2014 News Briefs - International Neuromodulation Society

Earlier News:

Later News:

January - December 2014


Company Opens U.S. Entity for Distribution of Deep Transcranial Magnetic Stimulation Systems

Dec. 30, 2014 - Beginning Jan. 1, 2015, Brainsway Ltd. will use its new entity, Brainsway USA Inc. for sales, marketing and customer support in the U.S. of its deep transcranial magnetic stimulation systems. Headquartered in the northeast, Brainsway USA also opened two U.S. regional service centers. (Globe Newswire)


Company Outlines Settlement for Shareholder Lawsuit

Dec. 29, 2014 - Covidien said it has proposed a settlement for a consolidated derivatives lawsuit blocking its pending merger with Medtronic, Inc. The $43 billion merger values its shares at $93.22 each, and the three shareholder lawsuits, first filed in July 2014, alleged a breach of fiduciary duty in agreeing to the merger. The company said that it created a memorandum of understanding in which it agrees to make certain additional disclosures related to the proposed transaction, as part of a stipulation of settlement. (Mass Device)


International Neuromodulation Society Members Present Difficult Pain Cases

December 2014 - International Neuromodulation Society members Timothy Deer, MD, and Jason Pope, MD, have published two reports in a series of articles about "Managing the Difficult Pain Case". The first concerns controlling pain from a brachial plexus injury with spinal cord stimulation (SCS), allowing the patient to wean off of several medications, including morphine. The second case concerned intrathecal ziconotide that relieved at least 80% of the pain from failed back surgery syndrome in a 63-year-old man who did not find sufficient pain relief from a trial of SCS. The patient next anticipated bilateral total knee replacement and plans to be weaned from all controlled-substance drugs. (Pain Medicine News)


Viewpoint: Deep Brain Stimulation and Biologics May Provide Combinatorial Treatment Strategies

Dec. 17, 2014 - Researchers in San Francisco propose combining cell transplantation and gene therapy with deep brain stimulation in Parkinson's disease to evaluate the biologic therapy. They list several potential advantages to such a clinical trial design, including the potential to reveal treatment paradigms relevant to other diseases of the brain. (Movement Disorders)


Company Receives Small-Business Funding for Home-Use Neurostimulation to Treat Overactive Bladder

Dec. 21, 2014 - Rosellini Scientific has launched nUro Inc. to develop a percutaneous tibial nerve stimulator for overactive bladder that can be operated at home. It involves an implanted neurostimulator and an unobtrusive external controller, which is only worn during therapy sessions. The company announced that to help fund the development, it has received a Phase I Small Business Innovation Research grant from the NIH's National Institute of Diabetes and Digestive and Kidney Diseases. (Virtual-Strategy Magazine)


Engineering Organization Receives R&D Funding to Work on a Micro-Stimulator

Dec. 18, 2014 - Draper Laboratory received $200,000 in Phase 1 funding from GlaxoSmithKline as part of its Innovation Challenge to develop micro-stimulators that may address one or more chronic health conditions - including cardiovascular disease, diabetes, arthritis, asthma, or cancer. Draper Laboratories previously developed an interface for the GSK Bioelectronics R&D group that can record the communication between individual populations of nerve fibers within the whole nerve bundle and deliver precision therapy when these electrical signals operate abnormally. The current funding will be applied to development of a hermetically sealed device that offers wireless processing and can be injected or inserted through a catheter. (PR Web)

Heart Failure, Hypertension Therapy Granted MRI-Conditional Status in Europe

Dec. 16, 2014 - CVRx Barostim neo is now cleared for MRI use in Europe under certain conditions, according to a company announcement. This second-generation carotid artery pulse stimulator is being developed as a therapy for some types of heart failure and drug resistant hypertension. (MedGadget)


Company Prepares for Shareholder Vote on Merger

Dec. 16, 2014 - Medtronic, Inc. announced it is ready for a shareholder vote Jan. 6, 2015, on the proposed merger with Covidien, now that the way has been cleared by anti-trust regulators from the U.S., European Union, China, South Korea and Canada. (Mass Device)

Company Says Patent Issued on Treatment for Balance Problems

Dec. 16, 2014 - Helius Medical Technologies, Inc. said it has received a U.S. patent "generally directed to a non-invasive neuromodulation therapy that includes stimulating the cranial nerves found in the mouth while the patient is engaged simultaneously in physical movement." The company's Portable Neuromodulation Stimulator (PoNS™) device induces neuromodulation by stimulating the cranial nerves found in the tongue, and is being studied for the treatment of balance disorder symptoms caused by traumatic brain injury and multiple sclerosis. (Business Wire)

North American Neuromodulation Society Issues Lifetime Achievement Award

Dec. 16, 2014 - The North American Neuromodulation Society presented a Lifetime Achievement award to Prof. Alim Louis Benabid, board chairman of Clinatec - The Edmond J. Safra Biomedical Research Center for his work on developing deep brain stimulation for Parkinson's disease. (News-Medical.net)


U.S. Agency Seeks Capabilities to Stimulate Peripheral Nervous System to Treat Disease

Dec. 15, 2014 - A news release says, "DARPA’s Electrical Prescriptions (ElectRx) program is seeking innovative research proposals to help transform neuromodulation therapies from last resort to first choice for a wide range of diseases." The agency has issued a notice of capabilities sought that "would leverage advanced sensing and stimulating technologies to target specific peripheral neural circuits that control organ functions." Both inflammatory disease and mental health disorders are being targeted. (Medical Design Technology)

Dorsal Root Ganglion Studies Presented

Dec. 15, 2014 - Twenty peer-reviewed abstracts were presented at the North American Neuromodulation Society meeting about dorsal root ganglion stimulation using Spinal Modulation's Axium neurostimulator system for chronic pain. The studies in Australia and Europe included chronic post-surgical pain, upper limb neuropathy, and visceral pain. (Business Wire)


Post-Traumatic Stress Disorder Clinical Trial to Start

Dec. 15, 2014 - Israel's Brainsway said it will carry out a clinical trial of deep transcranial magnetic stimulation with FDA clearance in 166 patients who have post-traumatic stress disorder. (Mass Device)

Brain Stimulation Said to Boost Performance on Anti-Anxiety Training

Dec. 15, 2014 - An article in Biological Psychiatry says transcranial direct current stimulation to a region of the frontal cortex helped subjects perform better at a task designed to retrain unhelpful patterns of attention that are known to maintain high levels of anxiety, in which participants endeavor to direct their attention away from "unhelpful information". (Health Canal)


Article Highlights Transcranial Magnetic Stimulation Use in Treatment-Resistant Depression

Dec. 15, 2014 - A news feature on transcranial magnetic stimulation for depression says up to one-third of patients can achieve remission, and about 50 - 60% of patients show some response. (U.S. News & World Report)

Neurosurgery Resident Presents Neuromodulation for Future Health Practitioners

Dec. 12, 2014 - International Neuromodulation Society member Shannon Hann, MD, has authored an article with INS President Simon Thomson, MBBS on a website devoted to future healthcare professionals that introduces neuromodulation as a modality they may see more of in their future. (Student Doctor Network)


Anti-Pain Device Clinical Trial Will Enroll Patients Who Have Axial Low Back Pain Without Prior Back Surgery

Dec. 12, 2014 - Stimwave Technologies Inc. announced a randomized, double-blind, placebo-controlled study, Tsunami, to evaluate its miniature, wireless anti-pain neuromodulation device in 45 patients who have chronic, non-specific-origin lower back pain. The study will begin enrollment in 2015 in the U.K., Netherlands, Switzerland and Belgium. In addition to pain reduction, secondary endpoints are quality of life, patients' global impression of change and reduction in opioid use. (Mass Device)

Company Presents Several Studies of Spinal Cord Stimulation at North American Neuromodulation Society Meeting

Dec. 12, 2014 - Retrospective data presented at the 18th North American Neuromodulation Society meeting show that stimulation targeting enabled by Boston Scientific Corporation's 32-contact Precision Spectra spinal cord stimulator system and anatomy-driven Illumina 3D™ software contributed to pain reduction that averaged more than 50% in 213 patients at 12 months. Other presentations included describing a 10-kHz spinal cord stimulation trial, ACCELERATE, and a clinical trial evaluating sub-perception multiple independent current control, WHISPER. (PR Newswire)


Scoliosis Patient Reported to Benefit From Spinal Cord Stimulation to Limit Chronic Pain

December 2014 - International Neuromodulation Society member Sanjay Sastry, MD, and colleagues in Florida report a case of a man with spinal curvature and chronic pain from spine surgery who successfully received a spinal cord stimulator implant to manage his chronic pain symptoms. (Pain Medicine News)


Business Column Describes Bioelectronic Therapies

Dec. 10, 2014 - In a healthcare innovation column the Financial Times mentions the GlaxoSmithKline initiative with SetPoint Medical to modulate the vagus nerve to treat inflammatory disease, and electroCore's research into vagus nerve stimulation therapies. The column also mentions FDA approval of the Inspire Medical Systems "bioelectronic" system to treat obstructive sleep apnea, and EnteroMedic's FDA-approved system to control food intake through vagus nerve stimulation. The column cites revival of a newborn by cardiac electrostimulation in 1928 as the start of the modern era of bioelectronic medicine. (Financial Times)


Membrane Might Add Sense of Touch to Prostheses

Dec. 10, 2014 - Researchers from Seoul National University report in Nature Communications development of stretchable ​silicon nanoribbon electronics for skin prosthesis that might transfer signals to nerves via an ultrathin multi-electrode array. (Business Insider Australia)

Optogenetics Research Suggests New Intervention Target in Temporal Lobe Epilepsy

 December/January 2014 - Data presented at the American Epilepsy Society’s annual meeting in Seattle indicate optogenetics may be a promising future therapy; researchers at the University of California in Irvine showed that in a mouse model of temporal lobe epilepsy, activating cells in the lateral cerebellar cortex or vermis with optogenetic lasers shortened seizures and in the case of the vermis, also prolonged seizure-free periods. The results indicate the cerebellum could be a good target for intervention, and reveal a strong influence between brain structures that are not typically thought to interact. (Neurology Now)


Political Leader Speaks Out in Favor of Bringing Deep Brain Stimulation to Ireland

Dec. 9, 2014 - After a session of the Oireachtas Health Committee, Dan Neville, the chair of the Fine Gael Party and assembly delegate to the Irish parliament, said that bringing a deep brain stimulation service to Ireland rather than flying patients to the UK for treatment will be kept under continuous review within the context of competing priorities. (Fine Gael)

Parents of Middle-Schooler with Dystonia Contemplate Future Deep Brain Stimulation Therapy

Dec. 6, 2014 - Relatives of a 12-year-old boy with dystonia describe their experience and how they are considering deep brain stimulation in the future, which is said to improve about 80% of the cases of his type of dystonia, DYTi. (American Epilepsy Society)

Physicians Update Recommendations on Deep Brain Stimulation in Severe Tourette Syndrome

December 2014 - International Neuromodulation Society members Andre Machado, MD, PhD; Alon Mogilner, MD, PhD; Joseph Neimat, MD; Barbara Changizi, MD; Verle Visser-Vandewalle, MD; Michael Pourfar, MD; J. G. Zhang, MD and colleagues have published updated recommendations regarding deep brain stimulation for Tourette syndrome, noting that the therapy can be a promising approach for a subset of medication refractory and severely affected patients. (Movement Disorders)

Ostomy Patient Publicizes Her Pain Relief from a Spinal Cord Stimulator

Dec. 8, 2014 - A woman who suffered neuropathic pain after a portion of her intestinal tract was removed says spinal cord stimulation relives 80-85% of her pain. (Great Falls Tribune)

Company's Pain Portfolio to be Presented

Dec. 8, 2014 - St. Jude Medical, Inc. will present data from 16 research abstracts about its product portfolio to provide spinal cord stimulation for chronic pain during the North American Neuromodulation Society annual meeting Dec. 11 - 14, 2014 in Las Vegas, NV. (Business Wire)


Authors Examine New Directions of Deep Brain Stimulation

December 2014 - International Medical Society member Jonathan Miller, MD, has co-authored an article about new directions in deep brain stimulation that says, "The intersection of advances in neuromodulation, neurophysiology, neuroimaging, and functional neuroanatomy has created an environment rife with new therapeutic possibilities." (PubMed)

Federal Agency, Patient Groups Team Challenge Developers to Devise Seizure Data Algorithms

Dec. 6, 2014 - The National Institute of Neurological Disorders and Stroke, American Epilepsy Society and the Epilepsy Foundation sponsored an online competition that drew 504 entrants who used recordings of seizures in both canines and people to try to develop algorithms to detect and predict the events. The winning team forecast abnormal brain activity with 82% accuracy. An article says the sponsors hope that one day the predictive algorithms will help to reduce seizures through being "married with the computing power of handheld devices and be used by epileptics." (Washington Post)


Company Starts Proof-of-Concept Anti-inflammatory Clinical Trial of Vagus Nerve Stimulation in Crohn's Disease

Dec. 4, 2014 - In conjunction with the  Crohn’s & Colitis Foundation’s annual conference in Orlando, SetPoint Medical announced the start of a clinical trial of a bioelectronic medicine therapy for Crohn's Disease. The proof-of-concept study will include patients at five centers in Europe whose condition did not respond to treatment with a tumor necrosis factor antagonist drug. SetPoint's implanted device will be used to stimulate the vagus nerve to produce a systemic anti-inflammatory effect. (Business Wire)

Merger Plans Receive Antitrust Clearance from China and Korea

Dec. 4, 2014 - The Chinese Ministry of Commerce and the South Korean Fair Trade Commission have accepted plans for Medtronic, Inc. to merge with Covidien Plc, according to Medtronic. With all antitrust clearances in hand, the companies now need sanction by the High Court of Ireland and shareholder approval. Covidien is based in Ireland and the combined company would have its tax domicile in Ireland, with operational headquarters in the U.S. (Mass Device)


Scientists Demonstrate Potential of Wireless Film to Serve as Retinal Implant

Dec. 3, 2014 - A collaboration between researchers in Israel and the U.K. has developed a light-sensitive film that could some day form the basis of a prosthetic retina. The film combines semiconductor nanorods and carbon nanotubes and has shown a response in neural tissue in preliminary studies. (The Hebrew University of Jerusalem)


Irish Health Officials Hear Benefits of Deep Brain Stimulation

Dec. 3, 2014 - The Ireland Committee on Health and Children planned to continue discussing deep brain stimulation benefits and how it can improve the lives of people with Parkinson's disease, a discussion started at its meeting last month with providers and patient representatives. (Houses of the Oireachtas)


Refractory Angina Pectoris Patients Showed Improved Perfusion After Spinal Cord Stimulation

Dec. 2, 2014 - International Neuromodulation Society members Pirkka Rautakorpi, MD and Markku Taittonen, MD, PhD, and colleagues from Turku University Hospital in Finland have published a prospective case series that indicated that three weeks of continuous spinal cord stimulation in 18 patients with refractory angina pectoris was able to alleviate myocardial perfusion abnormalities from coronary artery disease. (European Heart Journal Cardiovascular Imaging)


Pakistan Patient Expresses Appreciation for Deep Brain Stimulation Surgery

Dec. 4, 2014 - A patient who received a deep brain stimulation implant for an unspecified indication in Lahore last month spoke with the news media and expressed appreciation for government support for the surgery which he could not afford to have overseas. He said that the operation bestowed him a new life and he will not have to spend his life dependent on others. (Pakistan Observer)


First Auditory Brainstem Implants Performed on Preschoolers in India with Government Support

Dec. 3, 2014 - Two children in India had auditory brainstem implants with government support, which is usually available for the more-common cochlear implant procedure. The procedures, performed in November, were also written up in The Hindu. The surgery was presented as the first time it was done in Asia with government funding; a representative of a research foundation said the procedure has only been done in Korea, France, Germany, the U.S., Italy, Turkey and India. (The New Indian Express)


Article Highlights Military Research into Performance-Enhancing Technology

Dec. 3, 2014 - The U.S. military is researching brain-stimulation techniques for cognitive enhancement to improve focus or memory, as well as devices such as exoskeletons to permit carrying more weight. (Vox)

Company Reports Record Revenues, Plans to Present at International Neuromodulation Society Chapter Annual Scientific Meeting

Dec. 2, 2014 - Nevro Corp. booked its biggest revenue gain in the quarter ended Sept. 30, 2014, the company announced, with $8.7 million in revenues marking a 40% increase over the same period the year before. The company added that results of its randomized controlled clinical trial, SENZA-RCT, will be presented Dec. 12 in Las Vegas at the annual meeting of the North American Neuromodulation Society. The Senza spinal cord stimulation system is marketed outside the U.S. Combined with that revenue, the company also raised approximately $131 million in an initial public offering and secured a $50 million credit facility. (BusinessWire)


Feature Profiles Dystonia Patient Who Received Deep Brain Stimulation

Dec. 2, 2014 - A health care worker in Idaho who has dystonia described how her symptoms lessened after she had a deep brain stimulation implant. (Deseret News)

U.S. Patient Enrollment Complete for Study of Dorsal Root Ganglion Stimulation for Chronic Pain

Dec. 2, 2014 - Enrollment has been completed for the randomized, controlled pivotal trial of the Axium Neurostimulator System, Spinal Modulation announced. The study co-lead, International Neuromodulation Society member Timothy Deer, MD, commented that results from European studies have been promising. The U.S. study, ACCURATE, has 152 patients at 22 centers who either have pain from nerve injuries (peripheral causalgia) or complex regional pain syndrome. The Axium targets the dorsal root ganglion, unlike traditional spinal cord stimulators. The ACCURATE study is considered the largest study of patients who suffer from peripheral causalgia or complex regional pain syndrome. The design of the ACCURATE study will be presented at the annual meeting of the North American Neuromodulation Society, as well as clinical outcomes from Europe and Australia, where the system is commercially available. (CNN Money)


FDA Approves Injectable Wireless Spinal Cord Stimulator

Dec. 2, 2014 - Stimwave Technologies Incorporated announced it has received FDA clearance to begin marketing its wireless microtechnology device, the Stimwave Freedom Spinal Cord Stimulation (SCS) System (TM), which is expected to be available in January 2015. Bearing electrode contacts and a microchip, the device is 2-11cm in size, and can be implanted through a standard needle. The permanent implant is designed to allow a patient to have a whole-body MRI of up to 3 Tesla, greater than is currently available. David Kloth, MD, president of the International Neuromodulation Society's North American chapter, hailed the arrival of this new option for chronic pain patients. (Yahoo News)


Company Completes $17 Billion Debt Offering

Dec. 1, 2014 - Medtronic, Inc. raised $17 billion in a corporate-debt bond sale to finance its acquisition of Covidien Plc. The deal was the largest corporate debt offering in more than a year. The investment-grade bonds were given a provisional rating of A3 by Moody's Investors, and had maturities of three to 30 years, with a 10-year bond offering a total yield of 3.613. The offering reportedly attracted $45 billion in orders. (Wall Street Journal)


International Neuromodulation Society Member Comments on Value of Collaborative Database

Dec. 1, 2014 - The free-to-use, searchable, collaborative database of primary neurostimulation research data, WIKISTIM, announced in its monthly newsletter that it received two unexpected donations last month and will present two posters at the December annual meeting of the North American Neuromodulation Society. In addition to previous corporate donations and a new donation of $5,000 from Greatbatch in recognition of the value of the site to its employees, an individual donation came from International Neuromodulation Society member B. Todd Stizman, MD, PhD, who was quoted as remarking that the benefit of the resource "should be obvious to all [spinal cord stimulation] implanters, academic and private practice," adding that more should know about the initiative. Section editors include INS members Tracy Cameron, PhD; Elliot Krames, MD; Bengt Linderoth, MD, PhD; Robert Foreman, PhD; Richard North, MD; and Konstantin Slavin. MD. (A sacral nerve stimulation section editor is to be determined.) (WIKISTIM)


Imaging Studies Suggest Networks at Risk in Alzheimer's Disease and Schizophrenia

Nov. 24, 2014 - Imaging and modeling studies in 484 healthy subjects, published in the Proceedings of the National Academy of Sciences, indicate that a network of grey matter in the brain that develops in late adolescence and is responsible for coordinating "high-order" information from different senses covers the same region of the brain as the areas affected by Alzheimer's disease and schizophrenia. The finding may help in targeting treatments for the brain disorders. (BBC News)

Study Suggests That Motivation is a Factor in Cognitive Effects of Transcranial Direct Current Stimulation

Nov. 11, 2014 - Ensuring participants' incentives are high may expand cognitive benefits associated with transcranial direct current stimulation, according to experiments that compared performance, with and without financial incentives, between groups that had either high or low working memory capacity. The subjects with high working memory only showed an increase in oxygenated blood flow when the externally applied stimulation was coupled with a financial incentive, while the subjects with low working memory had improved oxygenated blood flow with and without the added incentive. The authors say that in clinical populations "motivation can be a concern" and so their finding is relevant for translational application of the technology. (Neuroimage)

European Regulators Clear Way for Companies to Merge

Nov. 28, 2014 - Medtronic, Inc. gained European regulatory approval for its $34 billion takeover of Covidien Plc on the condition it sells Covidien's Stellarex catheter business, which will be acquired by Spectranetics. The deal was cleared by US. authorities a few days earlier with the same condition. (Reuters)

Speaker Describes Influencing the Adoption of Neurostimulation Therapy

Nov. 28, 2014 - At the FT Global Pharmaceutical and Biotechnology Conference in London, JP Errico, founder and CEO of electroCore, explained its effort to reach coalitions of medical experts, patient advocacy groups, and payors in the U.S. and Europe to understand the benefits of their non-invasive neurostimulation technology and determine the placement of new therapies in the continuum of care through reimbursement approval processes. (PR.com)

Study Casts Doubt on Impact of Transcranial Direct Current Stimulation

Nov. 28, 2014 - Pooled results of more than 100 studies of the effects of transcranial direct current stimulation casts doubt on the physiological effects, and cognitive effects are at best small, short-lasting and not replicated across laboratories, according to a news feature. (New Scientist)

Study Suggests New Approach to Reducing Medication-Caused Dyskinesias

Nov. 26, 2014 - Researchers from the Institute of Molecular Bioimaging and Physiology of the National Research Council in Catanzaro, Italy, and the IRCCS Santa Lucia Foundation in Rome published in the journal Brain that transcranial magnetic stimulation of the lower frontal brain cortex inhibited dyskinesia from levodopa use in Parkinson's disease, suggesting new therapeutic protocols of combined medication and neurostimulation may improve function. (Research Italy)

Deep Brain Stimulation Surgeries for Movement Disorder Show Success in Iran

Nov. 24, 2014 - Iranian neurosurgeons at Shiraz University of Medical Sciences have successfully performed deep brain stimulation surgery on two patients, one with dystonia. They said the patients' movement symptoms were improved 70 percent. The dystonia patient was a 22-year-old woman who had difficulty moving some of her limbs and could not walk on her own. (Mehr News Agency)

Retinal Prosthetic Materials Researcher Thinks Promising Project May Fall Short of Funds

Nov. 23, 2014 - Researchers at Melbourne University are working on Bionic Vision Australia's high-acuity bionic eye that with 256 electrodes is far more sensitive than its 24-electrode early prototype that has been implanted in three patients. Due to lack the funds to do preclinical and clinical testing on the advanced version, they anticipate the project will fall into a "valley of death" prior to commercialization. Federal funding will run out in about six months and without a demonstrable next-generation product, private funding is unlikely, according to an interview with the professor who has led bench-top research on the electrode-dense interface, which is fashioned from artificial diamonds for durability and biocompatibility. (The Age)

European Parliament Member Speaks Up About Dystonia, Deep Brain Stimulation

Nov. 25, 2014 - European Parliament Member Glenis Willmott, chair of its Access to Medicines working group, notes that deep brain stimulation therapy is not widely available across the European Union. "In Romania for example, it is not reimbursed and in Ireland people have to travel abroad for treatment. In some EU countries the number of operations is capped," she writes, adding that when Parliament meets in Strasbourg, France, she will join an awareness event, a "Jump for Dystonia" photo call, on Nov. 25 and 26. (The Parliament Magazine)

Analyst Plans Webinar Regarding Factors Involved in the Evolution of Neuromodulation Technology

Nov. 25, 2014 - Innovations in neuromodulation technology are anticipated from advances in sensing, wireless communication, mircoprocessing, and mobile health approaches. Collaborative opportunities and trends in medical and non-medical applications will be addressed for registered participants in a webinar on Dec. 4, 2014 that touches upon the field's "technology and adoption roadmap" by a research analyst for the firm Frost & Sullivarn. (PR Newswire)

Northern India Facility to Provide Spinal Cord Stimulation for Chronic Pain

Nov. 25, 2014 - A man who suffered a crushed pelvis after being struck by a car several years ago is the first to successfully complete a trial stimulation with spinal cord stimulation at the pain clinic at the Postgraduate Institute of Medical Education and Research in Chandigarh in northern India. The man said that he feels like a normal person again after eight years and is experiencing better sleep at night. (Times of India)

Researcher Does Not Rule Out Therapeutic Potential of Spinal Cord Stimulation in Heart Failure

Nov. 24, 2014 - An investigator in the clinical trial of spinal cord stimulation (SCS) in heart failure DEFEAT-HF said at the American Heart Association annual meeting that although the trial did not meet its primary endpoint of a change in left ventricular end-systolic volume after six months of SCS for 12 hours a day, data on the 60 patients who completed the study and the trial parameters have not conclusively ruled out the hypothesis that SCS may be discovered to help under certain conditions in some patients. (Healio)

Researchers Work on Interface to Provide Feedback to Prosthetic Arm

Nov. 24, 2014 - Researchers at UCSF have created an 8-electrode brain-machine interface in preclinical work on developing proprioceptive feedback from a prosthetic device. The project is funded by the NIH and DARPA's REPAIR (Reorganization and Plasticity to Accelerate Injury Recovery) initiative. (UCSF)

Atlanta-Area Facility Starts Offering Deep Brain Stimulation

Nov. 24, 2014 - Northeast Georgia Medical Center near Atlanta has started offering deep brain stimulation services. An article about the therapy says it offers patients hope for a better life. (Gainesville Times)

Column Explores Brain Implant Technologies

Nov. 21, 2014 - The BBC covers "seven steps to creating a brain implant" in a column about future technology. The steps include choosing an interface, a stimulus code, a biocompatible electrode or optogenetic approach, an implant-friendly energy source, and choosing what functions to restore or augment -- currently for people with severe deficits. (BBC)

Overactive Bladder Treatment Touted in T.V. Interview

Nov. 21, 2014 - A woman whose overactive bladder symptoms were calmed by posterior tibial nerve stimulation says in a local television interview that she wants everyone affected by the condition to know there is hope. (KDKA)

Review Surveys Potential of Deep Brain Stimulation for Traumatic Brain Injury

November 2014 - Physicians at the University of Pittsburgh review deep brain stimulation in traumatic brain injury. (Journal of Neurosurgery)

Transcranial Magnetic Stimulation Studied in Rehabilitation Research

Nov. 21, 2014 - Ohio State University's Wexner Medical Center is one of the places that is conducting a clinical trial exploring the advantages of using transcranial magnetic stimulation in conjunction with stroke rehabilitation. The stimulation is intended to bring activity in the brain's hemispheres into better balance so exercises more productively help the stroke-affected hemisphere to rebuild connections. (Wexner Medical Center)

Man's Auditory Brainstem Implant a Success

Nov. 21, 2014 - A 48-year-old man is the first adult in New Zealand to have an auditory brainstem implant after losing his hearing in 2007 as a side-effect of antibiotics for blood poisoning. (New Zealand Herald)

Researchers Publish Progress Toward a Semiconductor-Based Pulse Generator

Nov. 20, 2014 - Collaborators in Taiwan and Israel have published their work to create a compact pulse generator on a CMOS chip. The 16-channel stimulation generator has five cascaded voltage doublers to boost the core voltage to more than 10 volts. Each channel is meant to be programmable and digitally controllable. They believe it could support already-implanted spinal cord stimulation leads, and are trying to improve performance for a wireless version to use ultrasonic transmitters and receivers. The article says that spinal cord stimulators "provide a low-cost alternative to pharmaceutical pain relief with fewer side effects . . . for a growing number of people." (Phys.org)

Company Announces Patent Allowances For Its Neurostimulation Power-Conditioning Technology

Nov. 20, 2014 - Solterix Medical Inc. of New York City announced the U.S. Patent Office has allowed claims for its technology, Limited Total Energy. Described as akin to gears on a car, it received a patent allowance to be applied to invasive neuromodulation devices as well as non-invasive, such as transcranial direct current stimulation. The company said their technology essentially reduces the power demand of electrical stimulation and makes it more energy-efficient. (Businesswire)

Vagus Nerve Stimulation Supplier Eyes New Neurostimulator Release Next Year

Nov. 20, 2014 - Cyberonics, Inc. may be offering a new version of its vagus nerve stimulation system for epilepsy as early as 2015 in the U.S., pending approval. The Houston, TX-area company recently opened its premises to a media tour. (Houston Chronicle)

Custom Provider of Skull Implants Acquires Neurostimulation Technology Supplier

Nov. 19, 2014 - Kelyniam Global, Inc. has supplied cranial and facial implants made-to-order to fill bony voids due to defects or disease. Now the Canton, CT-based business has acquired the custom neuromodulation active-implantable supplier MED-ALLY, LLC to diversify its product line. (Businesswire)

Company Has Started Testing Median-Nerve Stimulation for Refractory Hypertension

Nov. 18, 2014 - Valencia Technologies has created an implant to subcutaneously stimulate the median nerve to address hypertension. Their subcutaneous neuromodulation system has been tried in 38 people so far who have drug-resistant high blood pressure. The concept builds off the observation that acupuncture of the median nerve can lower blood pressure in some patients. (MedGadget)

Company Surpasses Goal in Opening Day of Trading

Nov. 19, 2014 - Second Sight Medical Products Inc. began trading 3.5 million shares on the Nasdaq exchange under the symbol EYES, opening at $9 each and more than doubling to $22.45. The company, which has the world's only approved retinal implant, reached a market valuation of $777.3 million. (Reuters)

Article Describes Benefits of Interventional Pain Management for Chronic Low Back Pain

Nov. 19, 2014 - International Neuromodulation Society members Elias Veizi, MD, PhD and Salim Hayek, MD, PhD published a narrative review in a special issue of Neuromodulation: Technology at the Neural Interface indicating that "some interventional pain medicine procedures have better risk-benefit and cost-effectiveness ratios than spine surgery." (HCP Live)

Study Presented at Conference Shows Brain-Stimulation Effect on Alertness

Nov. 19, 2014 - Military research that compared transcranial direct current stimulation (tDCS) vs. caffeine chewing gum and sham stimulation vs. placebo chewing gum and sham stimulation in sleep-deprived volunteers showed tDCS enhanced alertness for up to six hours after the 30-minute session. (The Guardian)

INS Member in Pennsylvania Noted for Role in Neurostimulation Guideline Development

Nov. 18, 2014 - International Neuromodulation Society member Steven Falowski, MD, was cited in a news brief for participating as a co-author of the Neuromodulation Appropriateness Consensus Committee's recently published guidelines. (Warren Hospital)

Device Makers May Offer Inspection Feedback in Brazil

Nov. 18, 2014 - The Brazilian medical device regulator ANVISA has begun taking feedback about medical device manufacture quality inspections, seeking evaluations on how the inspection went and what might be improved. (RAPS)

Company Says Tool Under Development Will Aid Neurostimulation Brain Surgery

Nov. 19, 2014 - A neurosurgical tool in early-stage development combines sensors and three-dimensional, previously acquired patient images to help surgeons avoid blood vessels and potentially to deliver neurostimulation, the developers said. Called "Chimaera," the handheld probe is under development by Cambridge Consultants. (Cambridge News)

Physicians in Calgary Enroll Patients in Depression Clinical Trial

Nov. 18, 2014 - Researchers affiliated with the University of Calgary’s Cumming School of Medicine have enrolled four patients in a study of deep brain stimulation in treatment-resistant depression, and are looking for 20 more. (CTV News)

News Coverage Explores Transcranial Magnetic Stimulation Treatment in Canada

Nov. 18, 2014 - An article about repetitive transcranial magnetic stimulation (TMS) for refractory depression in Canada says treatment-resistant depression costs the health-care system about $19,000 per patient per year, while TMS costs about $6,500 per person, and that patients who respond are likely to stay in remission with maintenance treatments. (CTV News)

Collaborators Make Flexible Potential Artificial Retina

Nov. 17, 2014 - A film of carbon nanotubes and semiconductor nanorods might function as a prosthetic retina in age-related macular degeneration, according to collaborating researchers in Israel and the U.K. (Photonics Online)

Start-Up With Pain-Relief Spine Implant Receives Funding

Nov. 17, 2014 - New funding was announced for a medical device start-up in Iowa that has a prototype spinal cord stimulator designed for direct implantation on the spinal cord. Direct Spinal Therapeutics, whose prototype was spun out of the University of Iowa Neurosurgery Clinic, received $140,000 from the Iowa Growth Fund and $1 million in funding from a private investor. The company calls its device the I (Iowa) Patch System. The concept was described in the spring in a presentation to the university regents. Developers say they anticipate more responders due to the direct spinal contact, and believe the implant below the dura would be safe. (University of Iowa)

Visiting Neurosurgeon Will Provide Deep Brain Stimulation in Oman

Nov. 17, 2014 - A neurosurgeon from India will be visiting the Al Hayat International Hospital once a month, offering deep brain stimulation at the Oman facility. Prior to this service, most patients with neurological disorders had to go out of the country to seek treatment and there were not many options for followup. (Muscat Daily)

Dose-Ranging Trial Shows Significant

Nov. 17, 2014 - In a dose-ranging Phase II clinical trial of external trigeminal stimulation in patients with treatment-resistant major depressive disorder, the 43 patients who received active therapy showed significant symptom improvement (41.2%) compared to 10.9% improvement in those who received sham treatment. NeuroSigma Inc., which funded the trial of its stimulation device, plans to present detailed results in 2015 at a scientific meeting, as well as to conduct a multi-center double-blind clinical trial. (PR Newswire)

Proxy Vote Schedule Set for Acquisition by Device Maker

Nov. 17, 2014 - Device maker Medtronic Inc. will hold a shareholders vote on Jan. 6, 2015 regarding its acquisition of Covidien. The same day, Covidien will hold shareholder meetings in Ireland, where it is based. (Minneapolis-St. Paul Business Journal)

Review Proposes Deep Brain Stimulation as a New Treatment for Refractory Hypertension

Nov. 16, 2014 - In patients who had both medication-resistant hypertension and neuropathic pain for which they were receiving deep brain stimulation (DBS), it was noticed that the treatment serpendipitiously lowered blood pressure and improved baroflex sensitivity. Clinicians in Bristol, UK, have prepared a review article that proposes the ventrolateral periaqueductal gray matter as the most promising target for DBS as a new treatment for drug-resistant hypertension. (Current Hypertension Reports)

Team Demonstrates in Lab Animals Gene Expression Via an Optogenetic Implant Wirelessly Controlled by Intentional Mental States

Nov. 11, 2014 - A European research team demonstrated in mice the ability to trigger expression of immune-system mediators in cultured, modified mammalian cells linked to the mice via a semi-permeable membrane. The resulting product was then detected in the animals' blood. The expression was controlled wirelessly by an infrared optogenetic switch that received electroencephalography (EEG) signals reflecting different consciously applied brain states in a human wearing an EEG headset. The researchers say mental states such as concentration or meditation led to differential control of the production of beta-interferon that was induced by the subcutaneous implants in the mice. Stimulation of the cultured cells in the implant produced an intermediary second-messenger compound that induced creation of the anti-infective protein. (Nature Communications)

Funding Opportunity Seeks Applications Regarding Recording and Modulation of the Nervous System

Nov. 5, 2014 - Applications for a funding opportunity at the National Institutes of Health, through the U.S. BRAIN Initiative, will be accepted starting in January 2015. The funding opportunity, "New Technologies and Novel Approaches for Large-Scale Recording and Modulation in the Nervous System" (RFA-NS-15-003), "seeks applications for proof-of-concept testing and development of new technologies and novel approaches for large scale recording and manipulation of neural activity, to enable transformative understanding of dynamic signaling in the nervous system." (NIH)

Article Describes the Forefront of Deep Brain Stimulation in Oregon

Nov. 13, 2014 - International Neuromodulation Society Director-at-Large Ali Rezai, MD, Ohio State University Associate Dean of Neuroscience and Director of the Neurological Institute, was interviewed in a news feature about deep brain stimulation (DBS). The article describes Dr. Kim Burchiel of Oregon Health Sciences University convincing the Oregon state medical board in 2013 that proper investigational use of DBS does not violate a state mandate against psychosurgery. Dr. Rezai is quoted as saying he believes in 20 years more than a million people will be walking around with brain implants, similar to the way cardiac pacemakers became better accepted over time. (Portland Tribune)

Book Presents the Stories of Neurotechnology-Implant Recipients

Nov. 12, 2014 - Jennifer French and James Cavuoto, executive director and vice president, respectively, of the nonprofit advocacy organization Neurotech Network, have published a new book profiling 10 individuals who have used a range of neurotechnology devices to address neurological conditions. Cavuoto, who is editor at Neurotech Press, calls the book Bionic Pioneers "one of the few health and medicine titles that pays tribute to the users who literally put life and limb on the line to help develop new neurotech therapies." (send2press)

Epilepsy Patient Describes the Benefits of Her Vagus Nerve Stimulator During Epilepsy Awareness Month

Nov. 12, 2014 - During Epilepsy Awareness Month, vagus nerve stimulation was described in a newscast as often appropriate for medically refractory epilepsy, yet not well-known. An epilepsy patient who has had an implanted vagus nerve stimulator for 10 years described switching to the therapy after having three grand mal seizures per day despite medication. The news coverage took place in Houston, where the device-maker, Cyberonics, is based. Cyberonics Chief Operating Officer Rohan Hoare, PhD, a member of the International Neuromodulation Society, commented that many more patients may be eligible for the device than receive one. (click2houston.com)

Spinal Cord Stimulation Device Maker Raises $145 Million in an Initial Public Offering

Nov. 12, 2014 - Nevro Corp. raised $144.9 million in its initial public offering. The Menlo Park, CA-based company said it hopes to market its high-frequency spinal cord stimulation device, Senza, by early 2016 if approved by the FDA. The company is conducting a prospective, randomized controlled pivotal trial comparing the treatment to low-frequency stimulation. (Mass Device)

Transcranial Magnetic Stimulation Device-Maker Raises More Than 15 Million Euros

Nov. 10, 2014 - Nexstim Oy raised EUR 15.3M in an initial public offering and expects to begin trading Nov. 14 on Nasdaq First North Finland and Nasdaq First North Sweden exchanges. The company sells navigated transcranial magnetic stimulation for pre-surgical mapping of motor and speech cortices. The company is investigating repetitive transcranial magnetic stimulation as part of post-acute stroke treatment in a clinical trial at 12 U.S. rehabilitation centers that participate in the NICHE study (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation). (Reuters)

Device Company Obtains External Debt to Finalize Acquisition

Nov. 10, 2014 - Medtronic, Inc. announced finalizing $16.3B in loans as part of its preparations to complete acquisition of Covidien. The financing includes a $11.3B bridge loan of 364 days, and an unsecured loan of $5B for a three-year-term. Two investment rating firms planned to lower the credit rating for Medtronic based on its approach to financing the deal, but the company hopes to maintain an investment-grade credit rating once the deal is final. (Mass Device)

Hypoglossal Nerve Stimulation Clinical Trial to Begin

Nov. 10, 2014 - ImThera Medical, Inc. has received FDA approval for a randomized, controlled, prospective, multi-center clinical trial of its aura6000® System for moderate to severe obstructive sleep apnea. The device, which is implanted under the tongue, has received CE mark approval in Europe. The trial will take place in Europe and in the U.S. under an investigational device exemption. The company calls the clinical trial THN3 (Targeted Hypoglossal Neurostimulation Study #3). In Texas, the Baylor College of Medicine said its Sinus Center will perform one of the first implants in that region. (Digital Journal)

Developer of Deep Brain Stimulation Receives $3 Million Life Sciences Prize

Nov. 10, 2014 - For his development of deep brain stimulation to control the tremors of Parkinson's disease, Alim-Louis Benabid, MD, PhD, has received a $3 million Breakthrough Prize that is funded by technology entrepreneurs including founders of Google and Facebook. The selection committee for the honor was comprised of the previous year's six winners in the life sciences. Initiated in 2012, the prize provides $3 million for each recipient and also includes awards in fundamental physics and mathematics. Its stated purpose is "to celebrate the best scientific work and also inspire the next generation of scientists." (streetinsider.com)

Researchers Demonstrate an Optogenetics Probe That Stimulates and Records Activity

Nov. 7, 2014 - In preclinical work, an MIT team demonstrated a flexible polymer optogenetics probe capable of recording neuronal activity and stimulating neurons with light. It consists of a transparent polycarbonate optical core; parallel conductive polyethylene electrodes for recording neuronal electrical activity; and cyclic olefin copolymer acting both as electrical insulation and optical cladding. (MIT News)

Initial Public Offering Opens Trading Above Expected Range

Nov. 6, 2014 - Nevro Corp. launched its initial public offering Thursday. The company priced 7 million shares at $18 a share (above the expected range of $15-17), and trading opened at $23.40. The company granted underwriters a 30-day option to purchase up to an additional 1,050,000 shares at the same price to cover any over-allotments. http://www.prnewswire.com/news-releases/nevro-corp-announces-pricing-of-initial-public-offering-281730441.html The company has developed a high-frequency spinal cord stimulator, and is trading on the New York Stock Exchange under the symbol NVRO. The offering was initially http://www.massdevice.com/news/nevro-boosts-ipo-126m?page=show expected to gross $126 million. (thestreetinsider.com)

Retinal Prosthesis Maker Seeks $31.5 million in Initial Public Offering

Nov. 6, 2014 - Second Sight Medical plans to raise $31.5 million in an initial public offering that may take place next week. The company makes the Argus II, the first retinal prosthesis approved for sale by the FDA. Second Sight plans to issue 3.5 million shares at $9 each on the NASDAQ exchange under the symbol EYES. (Mass Device)

Device Company Reports Progress in Seeking and Gathering Clinical Trial Data in Chronic Back Pain

Nov. 6, 2014 - Mainstay Medical International plc issued an update saying that more than 25 patients have been implanted with its investigational ReActiv8 device that addresses chronic back pain through helping to restore control of muscles that stabilize the lower spine. The company anticipates that data from 40 patients in its single-arm, prospective clinical trial should be sufficient to apply for CE mark approval. Meanwhile, the company met with the US. FDA regarding a proposed U.S. clinical trial under an investigational device exemption. Mainstay Medical anticipates making a submission to start s U.S. trial in the first quarter of 2015. (Mainstay Medical)

Patient from the United Kingdom Travels to India for a Less-Costly Procedure to Receive an Occipital Nerve Stimulator

Nov. 4, 2014 - A 32-year-old man from the UK with occipital neuralgia traveled to India to more affordably receive an occipital nerve stimulation implant to decrease his severe symptoms. He was quoted as saying the procedure cost half the amount it would have cost in the UK, where he said the NHS had declined to cover the cost of the surgery. (Hindustan Times)

U.S. FDA Seeks Comment on Soliciting Patient Input into Medical Device Development

Nov. 4, 2014 - The FDA has opened a docket, Docket No. FDA–2014–N–1698, for 30 days to receive feedback on how to include patient input on medical device development. Public comments are due Dec. 4, 2014. According to the announcement, the "FDA is currently using a variety of tools to help ensure that the patient community is involved in medical product discussions to enhance benefit-risk assessment." (Healthopolis)

Spinal Cord Stimulation Research Presentations Planned

Nov. 3, 2014 - Saying it is "reinforcing the company's commitment to developing innovative and effective therapies in neuromodulation," Boston Scientific Corporation announced it will present 12 months of data about its 32-contact Precision Spectra system and research into high-rate (10kHz) therapy and novel waveforms at the 18th annual meeting of the North American Neuromodulation Society taking place in Las Vegas Dec. 11 - 14, 2014. (Providence Journal)

Pakistan Adds a Deep Brain Stimulation Implant Capability

Nov. 2, 2014 - With a government grant to purchase deep brain stimulation equipment, a physician in Pakistan who was trained in the U.S. and the U.K. has performed the first two deep brain stimulation surgeries in the country, at the Lahore General Hospital. (The Express Tribune)

U.K. Researchers Look at Effects of Noninvasive Vagus Nerve Stimulation on Heart Function

Nov. 1, 2014 - Researchers at the University of Leeds have stimulated the vagus nerve externally through the tragus, a flap at the front of the ear, in 34 healthy volunteers, seeing a couple of positive effects on heart rate for up to 15 minutes after a 15-minute session. Those included about a 20 percent increase in heart-rate variability, and a 50 percent reduction in sympathetic nervous system activity, such as might be desired from drugs such as beta-blockers. (domain-b.com)

Preclinical Studies Support Option of Spinal Cord Stimulation for Parkinson's Disease

Oct. 30, 2014 - Researchers working in parkinsonian monkeys show that spinal cord stimulation disrupts a pathological, highly synchronized neuronal activity in the cortico-basel ganglia-thalamic loop, addressing the excessive functional coupling among these structures in a fashion similar to dopamine replacement therapy or deep brain stimulation. The research provides insight into the mechanisms underlying improvements in motor function through spinal cord stimulation in Parkinson's disease, providing support for consideration of this option as a slightly less-invasive treatment than deep brain stimulation. (Neuron)

International Neuromodulation Society Member Initiates U.S. Implantation of Advanced Spinal Cord Stimulation System

Oct. 30, 2014 - International Neuromodulation Society member Julie Pilitsis, MD, PhD, is credited as being the first in the nation to implant the new 32-contact spinal cord stimulator system, CoverEdge, intended to allow flexibility and better control of electrical impulses delivered to the spine through a computer algorithm that allows for multiple complex configurations during programming of the stimulation. (Health Canal)

Sound Therapy for Preschooler Who Received Auditory Brainstem Implant is Compared to a Triathlon

Oct. 30, 2014 - The family of a 3-year-old who had an auditory brainstem implant as the first child in a small U.S.-based clinical study said they hope that at minimum, the device will help him attend to auditory cues concerning safety, such as the honking of a car horn. He is returning for a followup clinic visit in November, after having been videotaped responding to music at an event in the summer. (Montreal Gazette)

Publication Publishes Editorial Urging Quicker Referral to Pain Specialists

2014 - An editorial about wait-times for spinal cord stimulation (SCS) includes a closing tribute to Krishna Kumar, MD, the editorial co-author, a member of the International Neuromodulation Society who died in April at the age of 83. The editorial suggests that if guidelines were adopted that call for wait times of no longer than eight weeks for assessment by a pain specialist, SCS would be considered early as recommended by various pain societies. (Pain Management)

Preclinical Neuromodulation Research Will Compete for a Large, Venture-Backed Funding Award

September, 2014 - An assistant professor at the Stanford University School of Medicine says she uses neuromodulation to try to answer questions about brains and aging in preclinical optogenetics research aimed at studying neural circuits at a systems level. She has submitted this work in competing for a new, privately funded research prize to fund biological investigations about longevity. The award comprises two components that each provide $500,000 in research funding. (paloatloprize.com)

Review: Stimulation of Dorsal Root Ganglion Minimizes Neuropathic Pain through Multiple Means

Oct. 29, 2014 - Upon reviewing the anatomical and physiological literature about the role of the dorsal root ganglion in the development of neuropathic pain, International Neuromodulation Society member Elliot Krames, MD, INS emeritus director-at-large, concludes that in the neuropathic pain state, electrical stimulation of this target has multiple effects that combine to stabilize and decrease hyperexcitability of dorsal-root-ganglion neurons, thereby decreasing the pain state. (Neuromodulation: Technology at the Neural Interface)

Columnist Calls for Long-Term View on Depression Recovery, Even with the Aid of Neurostimulation

Oct. 28, 2014 - A psychiatrist from the Cleveland Clinic observes that even after lifting of chronic depression through brain-stimulation therapy, many patients still need to rebuild their relationships and place in the world, a healing process that apparently cannot be rushed and requires emotional support without expectations of a short-term fix. (Scientific American)

National Institutes of Health Requests Input on New Program about Neuromodulation of Organ Systems

Oct. 28, 2014 - The National Institutes of Health would like to gather information and identify potential participants for a workshop about possible avenues to have interdisciplinary teams of investigators deliver circuit maps of organ systems and concepts for neuromodulation interventions that may require novel electrodes, tailored implant procedures, and stimulation regimes. The workshop's output will help to guide the new NIH cross-cutting research program, Stimulating Peripheral Activity to Relieve Conditions (SPARC). SPARC is anticipated to go into effect in fiscal 2015 through the NIH Common Fund, pursuant to available funds. (National Institutes of Health)

Interview Describes Plans for Brain Stimulation Research Aimed at Boosting Memory

Oct. 27, 2014 - The first human trials in epilepsy patients are expected this month in seven U.S. hospitals of a 256-channel brain stimulator by Medtronic, Inc. that is capable of recording, analyzing and stimulating. The research is part of a four-year Pentagon project to explore creating "prosthetic memory" for brain-damaged or demented patients, Restoring Active Memory. (Washington Post)

Spinal Cord Stimulation Developer Eyes Initial Public Offering in Early November

Oct. 27, 2014 - Nevro Corp., developer of a high-frequency Senza spinal cord stimulation device that is marketed in Europe and Australia, plans an initial public offering on the New York Stock Exchange, which is expected to price the week of Nov. 3. The Menlo Park, CA-based company seeks to raise $100 million by offering 6.3 million shares at a range of $15 - 17 per share. If its device receives FDA approval, the company would initiate a U.S. launch as early as 2016. (Nasdaq)

Conference: Neurotechnology Industry Appears Young, But Promising, and May Benefit from a Roadmap

Oct. 22, 2014 - A blog post about the Neurotech Leaders Forum in San Francisco says the conference presented a fairly sunny outlook for the neuromodulation industry, although the overall industry is still young. Some presenters discussed the possibility of hastening and optimizing development of the field through creation of an industry roadmap and technology standards. (Cirtec)

Nonprofit Research Center Wins Award

Oct. 25, 2014 - At the Neurotech Leaders Forum in San Francisco, the Cleveland Functional Electrical Stimulation Center was recognized by the publisher of the Neurotech Business Report newsletter with a Golden Electrode Award for being the most valuable nonprofit in neuromodulation research in 2014. The center was recognized for its translational research in neuroprosthetics, neurorehabilitation, and implanted devices. (Cleveland FES Center)

Acquisition Debt-Financing Plans Unveiled

Oct. 24, 2014 - Medtronic, Inc. plans to assume $16 billion in U.S. debt to help pay its $43 billion acquisition of Covidien, rather than using some $13.5 billion in overseas cash for the merger. The interest rate on the debt is expected to range from 4 - 4.5%. Standard & Poor's announced it would lower its short-term rating on Medtronic to A-1 if the deal goes through as described. Medtronic said the acquisition would be neutral to earnings by fiscal 2019, and that its overall tax rate will lower by 2%. (Mass Device)

Cardiologists Weigh Results of Clinical Trials of Vagus Nerve Stimulation in Heart Failure

Oct. 15, 2014 - According to a presentation at the annual Congress of the European Society of Cardiology, the ANTHEM-HF study met one primary endpoint by increasing the left ventricle ejection fraction, but the safety issues did not appear to be convincingly delineated. ANTHEM-HF was a prospective, multicenter study evaluating the effects of vagal nerve stimulation on various outcome parameters in 60 patients with advanced heart failure. In addition, the randomized, sham-controlled trial NECTAR-HF showed no objective difference from right-vagus-nerve stimulation after six months. More results of vagus nerve stimulation in heart failure should be seen in one to two years from INOVATE-HF, a study that is currently enrolling and will have approximately 650 patients. (Medscape)

Bioelectronic Innovation Challenge Fund Announced

Sept. 30, 2014 - GSK announced a $5 million Innovation Challenge Fund in bioelectronic medicine, for development of solutions for its previously announced Bioelectronics Innovation Challenge, which carries a $1 million award. Any tools or technologies developed through the fund and the Innovation Challenge's winning entry will be made freely available to the global research community. The application period for ICF funding is open and ends in the end of November. (Fierce Biotech)

Randomized Controlled Prospective Clinical Trial Demonstrates More Suppression of Painful Diabetic Peripheral Neuropathy with Spinal Cord Stimulation Than Medication Alone

November 2014 - International Neuromodulation Society member Robert van Dongen, MD, PhD, has co-authored a two-center randomized controlled trial of spinal cord stimulation (SCS) with best medical treatment, vs. best medical treatment alone, for lower limb pain from painful diabetic peripheral neuropathy. Of 22 patients trailed for SCS, 17 progressed to permanent implant and a control group of 14 patients received best medical care alone. Treatment success after six months was observed in 59% of the SCS patients and 7% of the patients who had received best medical treatment alone. The researchers also measured pain severity, pain interference with daily life, pain characteristics, health-related quality of life, pain interference with sleep, sleep quality and quantity, mood, and registered medication use at each followup. (Diabetes Care)

In Vitro Study: Slow-acting, Reactive Processes Constrain Neuromodulator Capacity to Suppress Network Synchrony

Oct. 23, 2014 - Researchers in Israel studying the tendency of networked cortical cells to return to synchrony over many hours (beginning at approximately 12 hours) after prolonged exposure to a cholinergic agonist write that the need to suppress synchrony might require periodic withdrawal of cholinergic input, such as what occurs naturally during non-rapid-eye-movement sleep. Their data were obtained using a feedback system and cultured neurons. (BMC Biology)

Physicians Express Concerns About Timely Access to Care

October 2014 - Three pain physicians in Florida write that insurance authorization for spinal cord stimulation (SCS) has changed to require face-to-face psychological screening rather than filling out a questionnaire due to concerns prompted by some "financially motivated physicians" about proper patient selection, care, and referral to permanent implants (that left some patients who experienced good pain relief with SCS trials not receiving permanent systems). They add that although early recognition of the need for SCS will minimize future use of narcotic pain medication, potentially saving money and allowing a return to work more quickly, they fear that wait times for SCS (that average more than 5 years in the U.S.) will grow even longer because of stricter criteria from insurers, long wait times for authorization and a decrease of 70 - 70% in reimbursement. They say that in contrast, the average wait time for SCS is one to two years in European countries that have nationalized health care. (Anesthesiology News)

Abstract: External Vagus Nerve Stimulation Reduced Migraine Duration, Severity

Oct. 23, 2014 - In an abstract from the 4th European Headache and Migraine Trust International Congress published in the Journal of Headache and Pain, a preliminary report on 30 patients who had migraine without aura showed that a single application of electroCore’s noninvasive vagus nerve stimulation device, gammaCore, completely resolved 44.8% of migraines within 30 minutes, and lessened an additional 11.4% of patients' attacks by 2 hours.  (BusinessWire)

Patients of Different Pain Durations Showed Similar Success Rates in Small Study That Included a Period of Burst-Mode Spinal Cord Stimulation

Oct. 21, 2014 - A comparison of pain suppression in 49 patients with an average pain duration of 9.6 years who had been undergoing spinal cord stimulation (SCS) for at least 6 months, and tried burst mode for two weeks, suggest that "the duration of pain is not an exclusion criterion for SCS and that similar success rates can be obtained for longstanding pain and pain of more recent onset." (Neuromodulation: Technology at the Neural Interface)

Study Explores Impact of Frequency in Burst-Mode Spinal Cord Stimulation

Oct. 21, 2014 - A study of burst spinal cord stimulation in 15 patients with failed back surgery syndrome showed no added benefit when the frequency was increased from 500 to 1000 Hz while keeping the total delivery of current to the spinal cord constant (five electrical pulses delivered at 500 Hz with 1000-μsec pulse width 40 times per second, vs. five spikes at 1000 Hz with 500-μsec pulse width 40 times a second.) (Neuromodulation: Technology at the Neural Interface)

Author Sets Forth Data for Vagus Nerve Stimulation and Responsive Neurostimulation

September/October 2014 - Comparing available data on outcomes of vagus nerve stimulation in medically refractory epilepsy and responsive neurostimulation presents a challenge in defining which patients would preferentially benefit from one or the other treatment, and how to best treat them with the stimulation, according to a commentary entitled, "Responsive Neurostimulation: The Hopes and the Challenges." (Epilepsy Currents)

Initial Public Offering Postponed Due to Market Conditions

Oct. 23, 2014 - Citing market conditions, EndoStim has postponed its initial public offering. The company markets a neurostimulation device for gastroesophageal reflux, with $1 million in sales for the year ending June 30, 2014. The company planned to raise some $35 million, trading under the symbol STIM. (Renaissance Capital)

Regulatory Filing Provides Companies' Merger Details

Oct. 22, 2014 - More details emerged in a regulatory filing Monday from Medtronic, Inc. regarding its merger with Covidien, which is based in Ireland and operated from Massachusetts. The deal is expected to close late in the fourth quarter or early in 2015, using external debt rather than Medtronic's offshore cash to finalize the transaction. Both companies' shares rose, and two asset-management firms were said to approve the financing structure. The filing said that structure was already approved by Japan, Russia, Israel and Turkey. (Mass Device)

Initial Public Offering Planned for Company Targeting Gastroesophageal Reflux

Oct. 22, 2014 - St. Louis-based EndoStim was scheduled for an initial public offering on Nasdaq of $35 million. The company's implantable system to address severe, medication-resistant gastroesophageal reflux disease has CE Mark approval, an investigative device exemption in the U.S., and is also marketed in South America and Asia. (equities.com)

Neurostimulation Lead with 32 Contacts Introduced at a Meeting in Boston

Oct. 21, 2014 - Boston Scientific Corporation introduced its 32-contact CoverEdge™ 32 and CoverEdge™ X 32 neurostimulation leads this week at the Congress of Neurological Surgeons meeting in Boston. The leads received CE Mark and FDA approval in 2012 and 2013, respectively. While the CoverEdge™ 32 contacts are closely spaced, the CoverEdge™ X 32 provides a wider and longer contact area. International Neuromodulation Society member Giancarlo Barolat, MD, said he believes the ability to cover a larger area of the spinal cord "will give patients, especially those with low back pain or pain in multiple areas, a better opportunity for relief." (PR Newswire)

INS Members Publish Summary of First Comprehensive Neurostimulation Guidelines
October 2014 - International Neuromodulation Society members Jason E. Pope, MD, Stanley Golovac, MD, Simon Thomson, MD and Timothy Deer, MD, have published a special report summarizing the findings of the the Neuromodulation Appropriateness Consensus Committee. (touch Neurology)

Subcutaneous Trigeminal Nerve Stimulation Patent Allowed

Oct. 21, 2014 - NeuroSigma, Inc. announced it has received a U.S. patent allowance for the use of  subcutaneously implanted electrodes and pulse generator for trigeminal nerve stimulation (TNS) for the treatment of neuropsychiatric disorders, including depression, ADHD, post-traumatic stress disorder and traumatic brain injury. The company markets an external system TNS system, the Monarch™ eTNS system, and anticipates using that to screen for responders who might then receive a fully implantable system, said International Neuromodulation Society member Ian Cook, MD, senior vice president and chief medical officer of the company, who led TNS development as a professor of psychiatry at the University of California, Los Angeles. The patent is co-owned by NeuroSigma and the University of California Regents, and exclusively licensed to NeuroSigma. (PR Newswire)

Article Examines Progression of Transcranial Magnetic Stimulation as a Therapy

Oct. 20, 2014 - A news feature about transcranial magnetic stimulation said it is firmly established as a depression treatment, and research is turning to other uses, from migraines to Parkinson's disease to post-traumatic stress disorder. (Stuff.co.nz)

Transcranial Magnetic Stimulation System to be Distributed in France, Reimbursed by Insurers in the United States

Oct. 20, 2014 - Brainsway Ltd. announced insurance coverage decisions in the U.S. representing about 17 million people, in addition to a distribution agreement in France for its deep transcranial magnetic stimulation system. Blue Cross Blue Shield will provide reimbursement for the use of the system in Florida, Kansas and Missouri, and Tufts provide reimbursement in Massachusetts. (Globes)

Neurostimulation Device Fabrication Methods Move Toward More Compact Systems

Oct. 20, 2014 - An article on vapor-deposition biocompatible coatings for neurostimulation devices claims neuromodulation therapy is becoming more readily accepted and mentions future energy-harvesting systems that will keep devices going from body heat, vibration, or radiofrequency waves. (MDT Design)

University Researchers Create Transparent Neural-Interface Electrode Array

Oct. 20, 2014 - Researchers at the University of Wisconsin have demonstrated in preclinical work a clear flexible graphene-based, carbon-layered electrode array, transparent to visible light and intended to  stimulate and record evoked response. The device was developed with funding from the Reliable Neural-Interface Technology program at the Defense Advanced Research Projects Agency. The researchers' work is published in Nature Communications. (University of Wisconsin-Madison News)

Article Describes Cooperative Research Development Agreement Involving External Trigeminal Nerve Stimulation

Oct. 16, 2014 - An article about the cooperative research and development agreement between Neurosigma, Inc. and U.S. Veteran's Administration offers details about regulatory approvals for the company's external trigeminal nerve stimulation system and its mode of action. The U.S. combat veterans in the Phase I trial will undergo eight weeks of stimulation at home at night, followed by assessment of changes in cognitive function and regional brain activity. The trigeminal nerve, near the surface of the forehead, was selected for bilateral stimulation since it is considered to offer a high-bandwidth pathway linked directly or indirectly to areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and cerebral cortex, that are involved in conditions such as epilepsy, depression, post-traumatic stress disorder, attention-deficit hyperactivity disorder. (PBR Drug Research)

Transcranial Direct Current Stimulation for Consumer Market Draws Investment and Media Interest

Oct. 8, 2014 - An ethics professor quoted in an article about a company that is pursuing transcranial direct current stimulation (tDCS) for the consumer market compares the state of the field's development to the Wild West of brain stimulation. The startup, Thync, raised $13 million in capital. Meanwhile, a writer for the BBC traveled to Boston to experience tDCS as an aid in concentration, describing some of the circuits and neurotransmitters involved in productive and unstressed attention-to-task. (Bloomberg Businessweek)

Neurostimulator to Be Tested in Traumatic Brain Injury; Initial Public Offering Postponed

Oct. 15, 2014 - NeuroSigma, Inc. is postponing its $50 million initial public offering due to poor market conditions. The company announced it has entered a cooperative research and development agreement with the Veteran's Administration to test its external trigeminal nerve stimulation device on veterans with traumatic brain injury. (Los Angeles Business Journal)

Subject of Real-Life Spy Flim Speaks Out About Treatments for Parkinson's Disease

Oct. 15, 2014 - A retired CIA agent whose subterfuge to arrange for six U.S. diplomats to escape Iran in the 1980 hostage crisis became the basis of the movie Argo revealed he was suffering from the effects of Parkinson's disease during the 2012 promotional tour. In an interview in the Washington Post, he said he turned to deep brain stimulation to help with his motor symptoms, although he still has unpredictable episodes of pain. He disclosed his diagnosis in conjunction with a symposium by the Focused Ultrasound Foundation. http://www.washingtonpost.com/blogs/local/wp/2014/10/15/argo-hero-tony-mendez-battling-parkinsons/ (Today Health)

TV Segment Features In-Depth Look at Deep Brain Stimulation Surgery at a U.S. Academic Center

October 2014 - In a TV segment, CNN medical correspondent Sanjay Gupta, MD presents deep brain stimulation, following physicians into the operating room at the University of Florida and explaining the role of the therapy to help manage effects of some neurological disorders. (CNN)

Materials Scientists Are Developing Dissolvable Medical Implants

Oct. 14, 2014 - University of Illinois researchers in Champaign-Urbana are working with transient electronic sensors patterned on ultra-thin pieces of silicon (with a 20- to 100-nanometer thickness) that can dissolve in a matter of weeks when implanted. They hope to find a way to actively trigger dissolution. (EE Times)

Deep Brain Stimulation Recipient Raises Funds for Parkinson's Disease Causes

Oct. 14, 2014 - The former assistant coach of the Predators, Brent Peterson, said his deep brain stimulation surgery in 2011 for Parkinson's disease was "very tough" but ended up being "really good" since he is not in a wheelchair and can move. With encouragement from Michael J. Fox to take constructive action, he started the Peterson Foundation for Parkinson's to raise money for awareness and education, has raised more than $400,000 since 2007. (Daily News Journal)

Columnist Presents the Option of Deep Brain Stimulation in Refractory Obsessive Compulsive Disorder

Oct. 14, 2014 - A columnist who is a clinical psychologist and researcher points out that deep brain stimulation may be an option for severe treatment-resistant obsessive compulsive disorder. (Huffington Post)

European Antitrust Regulators to Decide on Proposed Company Merger by Mid-November

Oct. 13, 2014 -  Medtronic, Inc.'s $43 billion purchase of Ireland-based Covidien Plc would put it on the same footing as Johnson & Johnson, according to Reuters, and will reduce the company's overall tax burden. The company said the goal was to boost its medical technology strategy rather than to acquire an overseas company to relocate its headquarters for tax purposes (a corporate "inversion"). European Union antitrust regulators plan to issue a decision on the deal by Nov. 14. The regulators' options are to approve, request concessions, or investigate. Analysts said since the companies are not competitors it is unlikely there will be significant regulatory worries. (Reuters)

Show Looks at Gains in Adapting Spinal Cord Stimulation for Post-Injury Functional Rehabilitation

October 2014 - In the "Next Big Thing," epidural stimulation to restore movement to spine-injured people is presented. The research takes place at the University of Louisville in Kentucky. (CNET)

Regional Award to Acknowledge Public Benefit of Federally Funded Brain-Stimulation Technology

Oct. 13, 2014 - Transfer of technology to the medical device company Brainsway through a license from the National Institute of Neurological Disorder and Stroke is being acknowledged with a regional Award for Excellence in Technology Transfer by the Federal Laboratory Consortium. The award recognizes a potential for substantial impact on public health, and will be presented Nov. 19 at an event for the Mid-Atlantic region of the consortium. The technology is being used to create deep transcranial magnetic stimulation systems, which have been FDA-approved for use in medication-resistant depression. (Nasdaq)

Neurosurgeons Publish Deep Brain Stimulation Guidelines for Obsessive Compulsive Disorder

Sept. 23, 2014 - The American Society of Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons have published a new guideline in Neurosurgery after assessing seven studies deemed high-quality that report research about deep brain stimulation in obsessive compulsive disorder. To date, bilateral stimulation of the subthalamic nucleus and nucleus accombens was shown to improve symptoms by around 36% in clinical trials. However, the authors say different subgroups, such as hoarders, may respond to different targets. (Medical News Today)

Study: An Artificial Arm with the Sense of Touch Has Permitted Recipients to Undertake Complex Tasks

Oct. 13, 2014 - According to a study in Science Translational Medicine two amputees who had under-the-skin wires and nerve electrodes implanted more than a year ago in their prosthetic arms to mimic a sense of touch performed such everyday activities as pulling a stem off a cherry or chopping wood. Healio reported on a news release on the topic from Case Western Reserve. (New York Times)

More Details Emerge on Proposed Merger of Device and Medical Supply Companies

Oct. 11, 2014 - Medtronic, Inc. announced that post-merger, it will operate Covidien PLC as a separate unit and overall will restructure around four international bases. The merger would be finalized upon approval by shareholders of each company, and is not anticipated until after Nov. 15, 2014. In addition to the Covidien medical supply group, the structure calls for a cardiac and vascular group, a diabetes group, and a restorative therapies group. (Minneapolis Star Tribune)

BRAIN Grant to Support Research into Using Nanoparticles for Neuromodulation

Oct. 10, 2014 - A research proposal by a research associate at Rockefeller University is one of 58 to receive the first grants from one of four federal agencies through the U.S. BRAIN initiative, the NIH announced. The $1.26 million grant over three years will support research into combining nanoparticles with radio waves or magnetic fields to turn neurons on and off. The approach might also be used to better understand the function of groups of cells, and would have the advantage of being able to access hard-to-reach cells or dispersed groups of cells. The molecular genetics researchers involved have termed this approach "radiogenetics". The BRAIN initiative is intended to ultimately create a dynamic brain map of neural circuitry. (Rockefeller University)

Foundation Aims to Expand Study into Stimulation that Restored Some Motion to Paralyzed Patients

Oct. 9, 2014 - The Christopher & Dana Reeve Foundation is hoping to raise $15 million to enable 26 patients with partial spinal cord injuries to participate in research into functional electrical stimulation at the University of Louisville in Kentucky. Four initial participants recovered some movement in the lower half of their body and improved cardiovascular and respiratory function. (People)

Report Discusses Current Neurostimulation Practice Updates Recommended by an International Neuromodulation Society-Convened Panel

October 2014 - International Neuromodulation Society President-elect Tim Deer, MD, was interviewed by Pain Medicine News about the issuance of the first comprehensive guidelines on neurostimulation for pain and ischemic disease, which appear in the August 2014 issue of Neuromodulation: Technology at the Neural Interface following work by the INS-appointed Neuromodulation Appropriateness Consensus Committee. He said updates to current practice include recommendations about thorough infection control and bleeding measures, as well as recommendations about credentialing. (Pain Medicine News)

Registration Opens for the North American Neuromodulation Society Annual Meeting in December

October 2014 - Registration has opened for the 18th annual scientific meeting of the North American Neuromodulation Society (NANS). The NANS meeting takes place from Dec. 11-14, 2014 in Las Vegas, NV, USA. (North American Neuromodulation Society)

Television Show Highlights How Veterans Have Benefited from Spinal Cord Stimulation

Oct. 7, 2014 - International Neuromodulation Society member Richard Maughon, MD, was quoted in a newscast about veterans using spinal cord stimulation, saying that worker's compensation studies show the therapy cost breaks even by the third year, and also that when veterans are taken off pain medications, their suicide rate goes down -- although no similar studies have been done in the general population. (WBRC)

Magazine Lauds Improved Spinal Cord Stimulator as a Breakthrough

Oct. 7, 2014 - Popular Mechanics profiles an athletic young woman with complex regional pain syndrome who is a patient ambassador for Boston Scientific Corporation in an article about the advantages of its spinal cord stimulation device with multiple independent current control, which she received last spring to manage pain in her foot and leg, replacing a previous model. The article calls the more precise targeting of nerve fibers an innovative achievement. (Popular Mechanics)

FDA Approves Trial System for Sacral Neuromodulation

Oct. 7, 2014 - Medtronic, Inc. received FDA approval for a system to identify which patients who have urinary incontinence may benefit from sacral nerve stimulation. The Verify Evaluation System is described as a more-discrete and user-friendly version of the external trial stimulator that had been used before. (Medgadget)

Patent Issued on Non-Invasive Brain Stimulation Technology Being Studied for Balance Disorders

Oct. 7, 2014 - Helius Medical Technologies announced its licensed technology, noninvasive neuromodulation for rehabilitation of brain function, has received a U.S. patent. The company is developing a Portable NeuroModulation Stimulator (PoNS™) that stimulates cranial nerves found in the tongue. The device is being investigated for treating balance issues caused by traumatic brain injury or multiple sclerosis. (Business Wire)

Foundation Funds Research into On-Demand Brain Stimulation to Address Gait Freezing

Oct. 6, 2014 - Research funded by the Michael J. Fox Foundation's program to improve or explore neuromodulation for Parkinson's disease will address gait freezing through on-demand stimulation to both the globus pallidus interna and the pedunculopontine nucleus -- which are hypothesized to be the gait "gas pedal" and "brake," respectively. (Michael J. Fox Foundation)

University to Open a Parkinson's Disease Research Center

Oct. 6, 2014 - The University of Michigan received a 5-year, $11.5 million grant from the National Institute of Neurological Diseases and Stroke to become a Morris K. Udall Center of Excellence in Parkinson's Disease Research, with a focus on the brain's cholinergic system and its role in gait and balance. As part of the center, the co-director of the university's deep brain stimulation program will lead an education and outreach effort. (Phys.org)

Neuromodulation Company Plans Initial Public Offering

Oct. 3, 2014 - Nevro Corp. has filed for an initial public offering under the symbol NVRO on the New York Stock Exchange. The company is reportedly seeking $125 million and intends to launch its Senza spinal cord stimulation (SCS) device by early 2016. The high-frequency stimulation device does not cause paresthesia. It would enter an SCS pain-relief market the company values at $1.5 billion overall. (San Francisco Business Times)

Retinal Prosthesis Maker Secures Additional Financing

Oct. 3, 2014 - Second Sight Medical, which filed for a $132 million initial public offering in August, is entering a bridge loan agreement with the Mann Group to provide operating capital through the end of November. The company developed the first retinal prosthesis approved for sale by the FDA, the Argus II implant. (Mass Device)

Device-Company Merger Will Not Involve Foreign Cash

Oct. 3, 2014 - Medtronic, Inc. announced that its previously announced merger with Covidien will use $16 billion in external financing rather than foreign cash, in the face of moves by the U.S. Treasury Department to tighten tax rules involving mergers or acquisitions of overseas companies. (Mass Device)

Patient Gets Rare Malaysian Deep Brain Stimulation Implant

Oct. 4, 2014 - Although deep brain stimulation (DBS) is rarely done in Malaysia due to its cost, Universiti Kebangsaan Malaysia Medical Centre performed its first DBS surgery Sept. 26 on a patient who has had Parkinson's disease since 2004 and had developed side-effects from the medication. The 67-year-old patient received some government funding. The surgeon said DBS is more cost-effective since reliance on medication is generally gradually reduced. He added DBS has a success rate of 80% and is superior to best medical treatment in improving quality of life. (The Star)

Researchers Receive Grant to Develop Electrodes to Sense Brain Neurotransmitters

Oct. 4, 2014 - The Mayo Clinic's Neural Engineering Laboratory received a $2.5 million grant to detect neurotransmitter release in the brain using diamond-coated electrodes and signal processing algorithms. The coated electrodes should provide durability and sensitivity over time. The grant was part of a first wave of investments from the U.S. Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which totaled $46 million. (Yuma News Now)

Survey Finds Functional Connectivity of Brain-Stimulation Targets

Sept. 29, 2014 - Looking at correlations in spontaneous brain activity shown in a database of MRI images, researchers have shown that deep brain stimulation affects brain circuits in higher brain regions, and the maps of those effects match maps showing effects of non-invasive brain stimulation for 14 different conditions, from Parkinson's disease to dystonia and Tourette syndrome. The authors of this analysis of functional connectivity data believe it will suggest stimulation approaches for more conditions. (Medical Daily)

Researchers Pursue a Variety of Implants to Augment Lost Vision

Sept. 29, 2014 - An article describes different implant locations and powering systems for retinal prostheses under development. (The Scientist)

Brain Scans Find Differences in Inhibitory Neurotransmitters in Patients with Tourette Motor Tics

Sept. 25, 2014 - A tic disorder specialist hopes to test the effect of transcranial direct current stimulation in Tourette syndrome, reasoning that the stimulation may boost GABA that would dampen the propensity for tics. This theory is supported by the recently reported finding in Current Biology that GABA is elevated in the supplementary motor area of brains of teens who have Tourette syndrome, compared to those who don't. (Everyday Health)

Preclinical Work in Neuroprosthetics for Paralysis Demonstrates Real-Time Control of Gait

Sept. 24, 2014 - Researchers who are planning a clinical trial with closed-loop robot-assisted stimulation in paralyzed patients report success in a rat model using a self-adjusting computational system so that electrical pulse width, amplitude and frequency need not be manually adjusted in real time for each individual. The animals showed fluid, precise movement in more than 1,000 steps, including climbing stairs of varying dimensions. This development of closed-loop epidural electrical stimulation to feed electric currents to sensorimotor circuits, appears in the journal Science Translational Medicine http://stm.sciencemag.org/content/6/255/255ra133. (Medical Xpress)

Interview Looks at Neurostimulation Development for the Coming Decade

Sept. 24, 2014 - A product leader at the UK-based Cambridge Consultants discusses a recent panel report forecasting neurostimulation market factors, saying clinical appetite will need to be enhanced and a vision of the future established for developers to align with that. (Medgadget)

Medical Center in Germany Will Offer Visual Prosthetic System

Sept. 23, 2014 - EBS Technologies' Next Wave device to restore a degree of vision in conditions such as stroke, glaucoma, traumatic brain injury and some other diseases will be available at the University Medical Center Hamburg-Eppendorf. The device consists of an EEG cap and special goggles that provide optical and electrical stimulation, and an EEG amplifier linked to the goggles. The process involves stimulating the retina while energizing the optic nerve to send signals to the brain. (Medgadget)

Small Study Documents Advantages of Electrical Current Steering in Deep Brain Stimulation

Sept. 23, 2014 - A Netherlands-based study of directional current steering in deep brain stimulation in eight patients with Parkinson's disease provided Class IV evidence that steering using the 32-contact electrode was well-tolerated and increased the threshold for side effects, increasing the therapeutic window by up to 1.5 mA. (Neurology)

Physicians Report European Study of Deep Brain Stimulation in Cervical Dystonia

September 2014 - A sham-controlled clinical trial in 62 patients with cervical dystonia who received deep brain stimulation showed that three months of active pallidal neurostimulation reduced symptoms of dystonia more effectively than sham, although 16 patients had serious adverse events, generally related to the device or the implant procedure. The multicenter study, funded by Medtronic, Inc., was reported by 33 co-authors, including members of the INS German chapter Wilheim Eisner, MD; Marcus Pinsker,MD; and Karl Kiening, MD. (The Lancet)

Article Describes Program to Develop Small Devices That Might Modulate Organ Function

Sept. 19, 2014 - An article compares tiny next-generation neuromodulation devices that are envisioned by the ElectRx program, which is sponsored by the Defense Advanced Research Projects Agency, to a smart pacemaker that would assess conditions and fix vital organs with stimulus patterns tailored to help maintain healthy organ function -- giving a boost to the body's natural processes of monitoring the status of organs and managing how they respond to disease The device might be used to treat inflammatory conditions and others, such as rheumatoid arthritis and inflammatory bowel disease, epilepsy, traumatic brain injury and even depression. (Mail Online)

Clinical Trial Starts to Investigate Deep Brain Stimulation in Dementia with Lewy Bodies

Sept. 18, 2014 - The first patient has been enrolled in a six-patient clinical trial of deep brain stimulation in a type of dementia called Dementia with Lewy Bodies. Because the cognitive impairments fluctuate in the condition, it is believed the "hard wiring" functioning on days when symptoms are worse could be aided by electrical stimulation to the area that has degenerated in the condition, the nucleus basalis of Meynert. (University College London)

Company to Launch Its Latest Brain-Mapping Device That Uses Transcranial Magnetic Stimulation

Sept. 18, 2014 - A next-generation device that combines transcranial magnetic stimulation and electromyography for presurgical mapping in neurosurgery will be launched at two meetings in October. The Nexstim NBS 5 will be showcased at the 6th International Symposium on Navigated Brain Stimulation in Neurosurgery, Oct. 10 - 11 in Berlin; and at the Congress of Neurological Surgeons 64th Annual Meeting from Oct. 18 - 22 in Boston. (PR Newswire)

Low-Back-Pain Device Company Details Plans

Sept. 18, 2014 - In an interview in the Irish Independent, Mainstay Medical CEO Peter Crosby, a member of the International Neuromodulation Society, said their strategy is to build a successful global company out of the Dublin-based business whose ReActiv8 muscle-stimulating device targets low back pain. The article said that at this phase, the company is not planning to be acquired or merged as smaller companies might. (Fierce Medical Devices)

Company Says Study Confirms Potential of Nerve-Stimulation to Improve Some Vision Loss

Sept. 18, 2014 - EBS Technologies, which offers a non-invasive brain stimulation for restoring partial vision to an impaired eye, issued a news release about a study by the company's co-founder, published in Neurology, that he said "confirms that repetitive transorbital alternating current stimulation (rtACS), otherwise known as electrical brain stimulation, can reactivate residual capabilities of brain function." The study said vision loss is not only caused by primary tissue damage, but also by a breakdown of synchronization in brain networks. The stimulation aims to bring about resynchronization of alpha band coherence. (Business Wire)

Company Plans to Present Data About Preventive Vagus Nerve Stimulation in Cluster Headache

Sept. 17, 2014 - ElectroCore announced that presentations this weekend at the European Headache and Migraine Trust International Congress in Copenhagen will include data from its PREVA study, a randomized, multi-center trial across several European countries, which showed that preventative use of non-invasive vagus nerve stimulation can reduce the frequency of cluster headache attacks by 43.4% versus the current standard of care, which resulted in only a 12% reduction. (EIN News)

Spinal Cord Stimulation May Enhance Drug Delivery to Ischemic Tissue

Sept. 15, 2014 - Researchers who theorized an improvement in oxygenated blood supply would facilitate enhanced delivery of the scheduled therapy in patients with recurrent high-grade gliomas report that in seven patients in a preliminary study, spinal cord stimulation during reirradiation and chemotherapy was associated with clinical improvement and longer survival than previously reported in this condition. (Integrative Cancer Therapies)

International Neuromodulation Society Announces Abstract Competition for its June 2015 12th World Congress in Montreal

Sept. 15, 2014 - The INS is pleased to announce its best abstract competition, in which the top five abstracts for the June 2015 12th World Congress in Montreal will be recognized for their quality, originality and ingenuity in basic or clinical science. For an abstract to qualify, its primary author must be a current member of the INS who has registered for the main congress. Recipients will receive their awards during the INS General Assembly of Members on the 9th of June. In addition, the primary author recipients will be refunded their congress registration fees. To access the abstract submission system please visit http://ins-congress.abstractcentral.com/. Download the instructions for authors here. The abstract deadline is 12 January 2015. (International Neuromodulation Society)

General-Practitioner Publication Features Guidance About the Role of Neuromodulation

Sept. 15, 2014 - International Neuromodulation Society Secretary Marc Russo, MD, and INS member Nick Christelis, MD, write in a publication geared to general practitioners in Australia a perspective on the role of neuromodulation in pain management. Indications for spinal cord stimulation, they say, include spinal cord stimulation include failed back surgery syndrome, complex regional pain syndrome, peripheral neuropathic pain, chronic peripheral ischaemic pain and refractory angina pectoris. (Pain Management Today)

Comparative Study Shows Benefit of Combined Sacral Neuromodulation and Drug Therapy

Sept. 15, 2014 - A research team reports in Urology Journal that a three-month study comparing sacral neuromodulation with antimuscarinic medication to medication alone showed greater benefit from the combined therapy in 240 women with idiopathic overactive bladder. (medwire News)

Pilot Study Proposed of Deep Brain Stimulation in Combat Veterans with Post-Traumatic Stress Disorder

Sept. 10, 2014 - A U.S.-based research team proposes a Phase I clinical trial of deep brain stimulation to the basolateral amygdala to address post-traumatic stress disorder in veterans, based in part on results in a rat model of the condition. The pilot randomized controlled trial will have a blinded, staggered onset of stimulation. (Trials)

Violinist With Essential Tremor Receives Deep Brain Stimulation

Sept. 11, 2014 - A former violinist with the Lithuania national philharmonic orchestra received a deep brain stimulation implant to treat her essential tremor in Tel Aviv. She played the instrument during surgery to help pinpoint the correct stimulation, and said it was a shame she didn't know about the surgery previously, having had to stop performing years ago. (Jerusalem Post)

Failed Back Surgery Syndrome Clinical Trial Comes to Long Island

Sept. 9, 2014 - International Neuromodulation Society member Brian Snyder, MD is participating at his Long Island practice in the multicenter SENSE™ (Subcutaneous and Epidural Neuromodulation System Evaluation) clinical trial of that compares spinal cord stimulation alone, and in combination with peripheral nerve field stimulation, for the treatment of chronic low back and leg pain due to failed back surgery syndrome. (EIN Presswire)

Cancer-Related Neuropathies Affect More Than One-Third of U.S. Cancer Survivors

Sept. 4, 2014 - The Neuropathy Association released an info graphic for Pain Awareness Month that explains the impact of cancer-related neuropathy, which affects more than on-third of the 14 million cancer survivors in the U.S. (The Neuropathy Association)

Newspaper Profiles International Neuromodulation Society President

Sept. 8, 2014 - International Neuromodulation Society President Simon Thomson, MBBS, FRCA, FIPP, describes his passion for ensuring access to appropriate neurostimulation treatments in a newspaper profile highlighting his work. He started an NHS pain service more than 20 years ago after being introduced to neurostimulation in the 1980s in Australia. “People with chronic pain are more at risk of depression and social isolation," the article quotes him as saying. “Often, they can feel they are passed from pillar to post, with very little answer to what is actually causing their agony.” (Echo)

Deep Brain Stimulation Pioneers Honored with Lasker Award

September, 2014 - The 2014 Lasker-DeBakey Clinical Medical Research Award goes to Alim-Louis Benabid, MD, PhD and Mahlon DeLong, MD, whose research helped to elucidate neural circuits involved in movement disorder and demonstrate brain targets for treating motor disorder through deep brain stimulation, which has been provided to more than 100,000 patients worldwide. (Lasker Foundation)

Company Offering Neurostimulation Therapy for Reflux Files for Initial Public Offering

Sept. 5, 2014 - St. Louis, MO-based Endostim Inc. has filed for an initial public offering in an offer valued at up to $40.25 million. The company plans  to trade on NASDAQ under the symbol STIM. Endostim previously received approval in Europe, Asia and South America of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD). The company plans a U.S. clinical trial. (247wallst.com)

Psychiatrist Anticipates More Use of Neurostimulation in Psychiatry

Sept. 5, 2014 - Neurostimulation can alter both neurochemicals and aberrant neuronal activity and is likely to become more common in psychiatric treatment, according to a question-and-answer column with a psychiatrist who favors its use the treatment paradigm. He said activity of the brain is as much electrical as it is chemical, and neurostimulation poses the advantage of being somatic and non-systemic. (Psychiatric Times)

Florida Patients Have More Access to Transcranial Magnetic Stimulation for Treatment-Resistant Depression

Sept. 4, 2014 - A Florida psychiatrist who added transcranial magnetic stimulation to his practice describes how it exerts an effect by polarizing areas of the limbic system. His first patient says in an interview that the therapy leaves her feeling clearer and more revitalized, in combination with counseling. She said it had been a last resort since she could not relieve the depression she felt since childhood with medications. (USA Today)

Researchers Visualize Neuronal Effects of Transcranial Magnetic Stimulation

Sept. 4, 2014 - Researchers in Germany have published in the Proceedings of the National Academy of Sciences work that shows for the first time, in cats, high-resolution imaging of the fleeting effects of transcranial magnetic stimulation in the cortex. The time-sensitive images were captured by using voltage-sensitive dyes anchored in cell membranes. The dyes fluoresce when neurons are activated or inhibited. (Medical Xpress)

INS President Speaks Out About the Evolution of Pain Management During His Career

Sept. 3, 2014 - In an interview publicized during Pain Awareness Month, International Neuromodulation Society President Simon Thomson, MBBS, FRCA, FIPP, describes the importance of listening to patients and his efforts to continually challenge the concept that chronic pain will always have a physical cause to be repaired through surgery. (Basildon and Thurrock University Hospitals)

Los Angeles-Area Medical Center Offers Recently Approved Neurostimulation Device for Obstructive Sleep Apnea

Sept. 3, 2014 - The first medical center in Los Angeles to offer the Inspire Upper Airway Stimulation system as a neurostimulation option for obstructive sleep apnea is Keck Medicine of the University of Southern California (USC). The device received FDA approval in April. (USC News)

MIT Bioelectronics Group Works on Nanoparticle Transducers and Flexible Polymer Probes for Optical Stimulation and Electrical Sensing

Sept. 3, 2014 - A materials science professor at MIT and her research team members are pursuing creation of flexible polymer probes that have been demonstrated to optically stimulate the spinal cords of mice whose neurons were altered to respond to light, as well as magnetic materials that might be injected into the brain to serve as a transducer for neural stimulation. The work is inspired by recent findings indicating that diseases that were previously not considered to have a neurological basis, such as diabetes, hypertension and infertility, may be treated with neuromodulation by employing bioelectronic medicine. (Phys.org)

Pilot Study Demonstrates Brain-to-Brain Transmission of Coded Information

Sept. 3, 2014 - By encoding letters of words into a binary code represented by a series of motor images, scientists have transmitted two simple four-letter words recorded with non-invasive brain-monitoring -- an electroencephalogram -- in one subject and received through non-invasive brain stimulation -- robot-assisted, image-guided transcranial magnetic stimulation (TMS) -- in three other subjects. Recipients sat with eyes and ears covered and received TMS stimulation to their visual cortex. The transmissions were perceived as bright lights in their peripheral vision, with the location of the light indicating its binary code (1 or 0). The data were transmitted from the sender's system to the receiving study subjects over a distance of 5,000 miles via the Internet. (CNET)

Dystonia Patient Shows Progress After Deep Brain Stimulation

Sept. 2, 2014 - A 9-year-old boy has made progress since his deep brain stimulation one year ago for generalized dystonia. He can now independently feed himself, drink from a cup, and stand unaided. (CBS-Denver)

Epilepsy Patient Receives Closed-Loop Vagus Nerve Stimulation Implant

Sept. 2, 2014 - A man in the UK who has had up to 60 epileptic seizures per day between ages 7 months and 40 years became one of the first people in the country to add, as an adjunct to his anti-seizure medication, use of the AspireSR implant, which delivers vagus nerve stimulation to deter a seizure upon sensing a change in heart rate. Since he has seizures even while asleep, the automated sensing and response is helpful to him. (Express)

Vagus Nerve Stimulation Improved Function and Reduced Symptoms in Heart Failure Clinical Trial

Sept. 1, 2014 - The Cyberonics, Inc. ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) open-label trial of vagus nerve stimulation (VNS), conducted at multiple centers in 60 patients who had moderate to severe heart failure and impaired heart function, indicate the treatment is safe, improves the heart's ability to pump blood, and reduces symptoms associated with chronic heart failure, according to data presented at the European Society of Cardiology meeting that was concurrently published in the Journal of Cardiac Failure. Stimulation of either the right or left vagus nerve appeared to help patients achieve changes in cardiac function. While the right vagus nerve had been believed to provide more of a baroreceptor impact, the left vagus nerve may be easier to access, and surgeons are used to working on that side for implanting other cardiac devices. Presenters said the left ventricular ejection fraction increased from 32.4% to 37.2% after six months of vagus nerve stimulation system treatment. (MedPage Today)

Vagus Nerve Stimulation Clinical Trial Does Not Show Remodeling in Heart Failure, Misses Primary Efficacy Endpoint

Sept. 1, 2014 - Boston Scientific reported at the European Society of Cardiology meeting that the primary efficacy endpoint was not reached in its vagus nerve stimulation clinical trial carried out in 96 New York Heart Association Class II-III patients who had heart failure and an ejection fraction of less than 35%, the NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) trial. After six months of treatment, blinded echocardiography showed no reduction in left ventricular end systolic diameter. Control patients begin to receive active therapy after six months of randomization, with all patients followed through 18 months to assess the safety endpoint. Despite no significant effect on cardiac remodelling or functional capacity, treatment did result in significantly improved symptomatic scores in quality-of-life metrics. (Medlatest)

Authors Review Studies of Transcranial Direct Current Stimulation in Learning, Behavior, Memory, and Motor Control

Sept. 1, 2014 - Psychology researchers at the University of Queensland have reviewed an escalating number of studies utilizing transcranial direct current stimulation (tDCS) to understand cortical substrates of behavior. The authors review its application in cognitive and motor training, its use to understand neuronal activity underlying perception, learning and memory (such as fluctuations in frequency and phase), and suggest how key methodological issues might be addressed. (Cell)

Expert Ponders Path Forward for Neuromodulation for Fecal Incontinence

September 2014 - In an article listed as most-read, "Neuromodulation in an Era of Rising Need and Cost: A Time for Multifaceted Consideration," a German surgery professor and expert in coloproctology notes that posterior tibial nerve stimulation offers moderate benefit as a fecal incontinence therapy and might elicit broader acceptance of more-invasive methods such as sacral neuromodulation. He questions how access may evolve, such as who should assess needs and deliver such therapies and what the expense may be. The author calls for "the guidance and support of the relevant professional societies" to approach the issue broadly beyond any particular commercial interest. (Diseases of the Colon and Rectum)

Benefit of Spinal Cord Stimulation in Painful Diabetic Neuropathy Shown in First Randomized Controlled Clinical Trial

Aug. 29, 2014 - International Neuromodulation Society members Kaare Meier, MD, PhD, Harold Nijhuis, MD, Wim Duyvendak, MD, Thomas Enggaard, MD, PhD, and colleagues report the first multi center randomized controlled trial of spinal cord stimulation (SCS) in medically refractory painful diabetic neuropathy. Sixty patients with lower-extremity pain were enrolled. After six months, patients receiving SCS plus best medical practice had average visual-analogue-scale pain intensity scores drop from 73 to 31. Patients who did not receive SCS remained at their baseline level of pain intensity, 67, during the six-month followup. (Science Direct)

Consensus On Benefits of Constant Current Over Time in Deep Brain Stimulation

Aug. 29, 2014 - Although epilepsy treatment has already embraced constant-current deep brain stimulation (DBS) devices, there has been little reporting of constant-current DBS devices in movement and neuropsychiatric disorders. The results of a consensus meeting sponsored by the Parkinson Alliance are reported by International Neuromodulation Society member Jay Shils, PhD and colleagues. They determined that since impedance varies considerably between patients and over time and encapsulation can occur, it makes sense that all new devices will likely use constant current even if, given the potential benefits, it will be unlikely that there will be many head-to-head comparator trials. Safety will not be impacted and science supports the use of constant current even if data are lacking. (Neuromodulation: Technology at the Neural Interface)

Small Study Indicates Noninvasive Brain Stimulation Boosts Memory in Healthy Subjects

Aug. 28, 2014 - Enhancing functional connectivity and plasticity in the hippocampus of 16 healthy volunteers through five daily sessions of transcranial magnetic stimulation allowed the study subjects to improve memory-test scores by 30%, according to research at Northwestern University that appears in this week's issue of Science. (BBC News)

After Noninvasive Brain Stimulation, Healthy Volunteers Reduced Appetite and Food Consumption

Aug. 28, 2014 - Eight daily sessions of transcranial direct current stimulation (tDCS) in 14 healthy volunteers led to a 14% reduction in caloric intake from a buffet and lower appetite scores, according to research published in The American Journal of Clinical Nutrition. The National Institute of Diabetes and Digestive and Kidney Diseases has launched a clinical trial on the effects of tDCS on weight. (Newsweek)

Brain-Mapping Study Indicates Trade-Offs in Boosting Cognitive Scores

August 2014 - Neuroscientists who conducted brain-mapping at the University College London on areas responsible for numerosity and duration judgments report in the Nov. 15, 2014 issue of NeuroImage that while transcranial direct current stimulation (tDCS) improved performance in one task, it impaired performance in another. They write, "application of anodal tDCS to the left-PPC and cathodal tDCS to the right-PPC . . . increased accuracy in the numerosity judgement task and impaired accuracy in the duration judgement task, while application of anodal tDCS to the right-PPC and cathodal tDCS to the left-PPC . . . increased accuracy in the duration judgement task and impaired accuracy in the numerosity judgement task." Their findings agree with the theorem that the parietal cortex may be the primary site for common neural processing of magnitudes in the different dimensions of time, space, and quantity. However, rather than support the general consensus that neuron firing-rate is affected globally by electrical stimulation, their findings show the modulation can be selective. (Science Direct)

Company Says the FDA Has Cleared Its Manufacturing Plant

Aug. 27, 2014 - St. Jude Medical said the FDA cleared a warning letter regarding manufacturing at its Plano, Texas plant where the Eon and Eon Mini spinal cord stimulation devices are made. The company had recalled some of the devices in 2012 due to battery failures and overheating during discharge. (Mass Device)

Defense Agency Starts a Bioelectric Medicine Program

Aug. 27, 2014 - "Like a tiny, intelligent pacemaker" is how a a program manager from the Defense Advanced Research Projects Agency describes a potential future means of managing a number of challenging medical conditions through precise modulation of the peripheral nervous system. The research program, ElectRx, would develop closed-loop systems that provide stimulus patterns that help maintain healthy organ function. (Medical Design Technology)

Emerging Neuromodulation Company Files for Initial Public Offering

Aug. 26, 2014 - Los Angeles-based NeuroSigma, Inc. has registered to undergo an initial public offering. The proceeds would help to fund a pivotal trial of is external trigeminal nerve stimulation system as an adjunctive treatment for drug-resistant epilepsy, develop a second-generation system, and advance clinical studies for neuropsychiatric indications. The company also plans retire $2.4 million of debt with the proceeds. (PR Newswire)

Device Maker Acquires Developer of Deep Brain Stimulation System

Aug. 26, 2014 - Medtronic, Inc. acquired Sapiens Steering Brain Stimulation for approximately $200 million in an all-cash transaction. Sapiens is developing a deep brain stimulation system with 40 individual stimulation points that may be more precise and require a shorter procedure time. Medtronic will keep Sapiens' site in Eindhoven, The Netherlands as a research and development center for its Neuromodulation business unit. Sapiens was spun out of Philips Healthcare in 2011 as a privately held enterprise. (NASDAQ)

Therapy to Undergo Evaluation as Adjunctive Treatment for Post-Traumatic Stress Disorder

Aug. 25, 2014 - Up to 74 combat veterans will be recruited for a double-blind study of external trigeminal nerve stimulation as an adjunctive therapy in post-traumatic stress disorder at the University of California, Los Angeles. The study, funded by the U.S. Army Medical Research and Material Command, will use devices provided by the emerging company NeuroSigma, Inc. (Drug Discovery & Development)

Evolving Science of Neuromodulation Described in News Release About First Comprehensive Consensus Guidelines

Aug. 25, 2014 - International Neuromodulation Society member Robert Foreman, MD, described synergies between basic and clinical pain-therapy research in a news release about the publication of neurostimulation guidelines from the Neuromodulation Appropriateness Consensus Committee. (University of Oklahoma Health Sciences Center)

Elderly Do Not Have Significantly More Complications From Deep Brain Stimulation for Parkinson's Disease

Aug. 25, 2014 - International Neuromodulation Society member Shivanand P. Lad, MD, PhD and colleagues retrospectively reviewed 1,757 patients who underwent deep brain stimulation for Parkinson's disease between 2000 and 2009, and in a multivariate analysis, found patients older than 75 years showed a similar 90-day complication risk compared with younger counterparts. (JAMA Neurology)

Metropolitan Newspaper Covers INS Member's Public Presentation on Deep Brain Stimulation

Aug. 24, 2014 - International Neuromodulation Society member Kathryn Holloway, MD responded to questions from the public at a seminar in Richmond, VA about deep brain stimulation, Parkinson's disease, specific symptoms, timing of therapy, research and the presence of other conditions. (Richmond Times-Dispatch)

Europe, Australia Issue Patents for High-Frequency Spinal Cord Stimulation

Aug. 25, 2014 - Nevro Corp. announced it has received patents in Europe and Australia related to spinal cord stimulation with its proprietary high-frequency system that delivers electrical pulses at a rate of up to 10,000 per second (10 kHz). The stimulation differs from lower-frequency spinal cord stimulation for back and leg pain by not causing tingling from paresthesia. More patents are pending the company said. (PR Newswire)

Experts Call for Regulation of Any Use of Transcranial Direct-Current Stimulation

Aug. 23, 2014 - Transcranial direct current stimulation has attracted consumer interest for its potential to enhance some cognitive activities. In response, academics are calling for its use to be regulated, even for non-therapeutic use, such as by the do-it-yourself community of technology enthusiasts. One neurologist at Yale University comments that the "marketing is a couple of steps ahead of the science." (BBC)

France to Fund Initial Implants of Retinal Prostheses

Aug. 22, 2014 - The French Ministry of Health will fund the first wave of patients to receive the Argus II retinal prosthesis, according to the device-maker, Second Sight Medical. The company said that 36 patients will receive the devices for vision loss from retinitis pigmentosa in a contract through France's Forfait Innovation program meant to support the emergence of medical innovation. (Mass Device)

Neuromodulation Appropriateness Details Presented

Aug. 21, 2014 - The Neuromodulation Appropriateness Consensus Committee's first comprehensive guidance on the use of neurostimulation in chronic pain is reported in the online, multi-disciplinary publication Phys.org. The coverage includes details about complications and their avoidance, as reported in the peer-reviewed findings of the committee in the Aug. 2014 issue of Neuromodulation: Technology at the Neural Interface. (Phys.org)

Neuromodulation Revenues Add to Company's Quarterly Earnings

Aug. 19, 2014 - Medtronic Inc. reported first-quarter 2015 earnings with Neuromodulation and Surgical Technologies businesses offsetting declines in its Spine business, with the Restorative Therapies Group overall showing an increase of 3% on a constant currency and reported basis. The group's overall sales for the quarter were $1.603 billion. Neuromodulation revenue was up 11% on a constant currency basis or 12% as reported, totaling $479 million for the quarter. The drivers included pain stimulation, deep brain stimulation and gastroenterology/urology. The company's overall revenue was $4.273 billion, up 4% from the same quarter a year ago on a constant currency adjusted basis, or 5% as reported. (MarketWatch)

First Cluster Headache Patient Receives Sphenopalatine Ganglion Neurostimulator

Aug. 18, 2014 - International Neuromodulation Society Director-at-Large Ali Rezai, MD, was quoted in a story about the first implant of the Autonomic Technologies, Inc. neurostimulator that is undergoing a clinical trial in the U.S. in cluster headache patients. The device stimulates the sphenopalatine ganglion beneath the cheek in the upper jaw when a patient uses a hand-held controller to elicit stimulation when a cluster headache starts. Dr. Rezai said the main advantage of neurostimulation is that "it's reversible and adjustable, and you're just modulating and blocking the pain signals." (Medical Xpress)

Study Indicates External Vagus Nerve Stimulation May Hold Promise for Helping Treat Heart Failure

Aug. 20, 2014 - Researchers at the University of Leeds have published in Brain Stimulation that transcutaneous vagus nerve stimulation may have benefits for heart health through reducing sympathetic nerve activity. They studied externally applied stimulation to the auricular branch of the vagus nerve (distributed to the skin of the ear) in 48 healthy subjects, resulting in increased heart rate variability. They postulate that indication of increased parasympathetic activity may suggest a potential intervention for conditions such as heart failure. (University of Leeds)

Commentary Notes Advantages and Concerns About Occipital Nerve Stimulation for Medication-Resistant Migraine

Aug. 19, 2014 - Occipital nerve stimulation effectively relieves medication-resistant chronic migraine for more than one year, providing good or excellent headache relief, although a high rate of adverse events remains a concern, according to a research highlight about a randomized controlled trial with 157 subjects. (Nature Reviews Neurology)

Deep Brain Stimulation Patient Resumes Classical Music Career

Aug. 17, 2014 - A concert violinist received deep brain stimulation in 2009 for essential tremor at the Mayo Clinic in an operation that included his playing a violin during the procedure with a bow equipped with an accelerometer to check the effectiveness of target stimulation. He returned to play with the Minnesota Orchestra within weeks. (CNET)

Private Vagus Nerve Stimulation Firm Selects Investment Banking Company

Aug. 18, 2014 - Saying it is fully funded until 2016, electroCore reports increasing interest in its non-invasive vagus nerve stimulation therapy over the last six months from Medical device companies and pharmaceutical and technology companies as well. The New Jersey-based privately held company has appointed the investment banking firm Piper Jaffray to assist in partnering discussions with pharmaceutical companies regarding commercialization of the technology. (Market Watch)

Neurology Group Updates Guidelines for Vagus Nerve Stimulation in Epilepsy

Aug. 18, 2014 - The American Academy of Neurology has updated its evidence-based guideline concerning vagus nerve stimulation for the treatment of epilepsy, saying it "may be considered progressively effective in patients over multiple years of exposure," and improvement in mood may be an additional benefit in adults with epilepsy, while overall, it may be considered an adjunctive treatment for children with partial or generalized epilepsy. (Clinical Neurology News)

FDA Calls for Workshop on Brain-Computer Interfaces Aimed to Augment Movement of Patients

Aug. 18, 2014 - In November the FDA will hold a workshop on brain-computer interfaces to discuss scientific, clinical and regulatory considerations of neuroprostheses under development to aid movement of paralyzed patients or amputees. That discussion could influence draft guidance. (The Gray Sheet)

Mice Showed Gains in Post-Stroke Recovery With Optogenetic Stimulation

Aug. 18, 2014 - A Stanford University research team has shown that stimulating the motor cortex in mice using optogenetics allowed the animals to improve their recovery from stroke, even five days afterwards. The study was published in the Proceedings of the National Academy of Sciences. The authors hope to identify which brain circuits might be most amenable to post-stroke intervention in a potential future human clinical trial. (BBC News)

Canadian Firm Works on Sleep Apnea Medical Implant

Aug. 16, 2014 - Canadian-based Ergoresearch Ltd. announced a $590,000 royalty payment to its medical device subsidiary Victhom Laboratory Inc. represents "a strong validation" of a neurostimulation approach to obstructive sleep apnea completed by its partner Otto Bock Healthcare. The technology records and stimulations peripheral nerves, delivering therapy only when necessary. Further royalties may be forthcoming if the device is commercialized. (Sleep Review)

Article Describes Deep Brain Stimulation for Dystonia

Aug. 15, 2014 - An article about deep brain stimulation for dystonia says it has been a gold standard for relieving symptoms for some patients since becoming available about a decade ago. (WWSB)

Article Highlights Neurostimulation Appropriateness Consensus Committee Findings

Aug. 14, 2014 - International Neuromodulation Society President Simon Thomson, MD, was interviewed for a news feature about work of the Neuromodulation Appropriateness Consensus Committee that resulted in the first comprehensive peer-reviewed guidance for neurostimulation therapy, which appears in this month's issue of Neuromodulation: Technology at the Neural Interface. The article cites the effectiveness and cost efficiency of the therapy, pointing out that the co-authors are addressing "current gaps related to this treatment modality". (Medscape)

Burglars Take Chronic Pain Patients' Investigational Neurostimulation Controller

Aug. 14, 2014 - A woman who was participating in a clinical device trial has lost the patient controller that allowed her to switch between stimulation parameters for her spinal cord stimulator implant, when the remote control was stolen along with other electronics during a residential burglary. News reports said her controller was only one of three in her country. She said she has endured massive spasms of pain since the burglary two weeks ago, missing sleep and cutting back hours at work. (New Zealand Herald)

Visual Prosthesis Company Plans a Public Stock Offering

Aug. 13, 2014 - Second Sight Medical plans a $32 million public offering, on NASDAQ under the ticker symbol EYES, while it considers trying to expand the market the its Argus II visual prosthetic beyond the relatively few sufferers of retinitis pigmentosa to the wider group of people who have age-related macular degeneration. Meanwhile, it is at work on a next-generation device, the Orion I, that its leadership believes could address nearly all forms of blindness, and that could be developed two to three years after the stock offering. (Mass Device)

Neuromodulation: Technology at the Neural Interface Publishes the First Comprehensive Neurostimulation Guidelines

Aug. 12, 2014 - The  Neuromodulation Appropriateness Consensus Committee, comprised of 60 experts convened by the International Neuromodulation Society (INS), publishes the first comprehensive guidance on the use of neurostimulation for chronic pain and ischemic disease in the August 2014 issue of the official journal of the INS, Neuromodulation: Technology at the Neural Interface. (Newswise)

German Health System Will Cover Retinal Implant

Aug. 11, 2014 - Retina Implant AG announced the German health system will cover its implant to partially restore vision in late-stage retinitis pigmentosa, Alpha IMS. The microchip-based device is implanted behind the retina, to stimulate healthy nerve cells there. The device received CE mark approval in 2013 and this is its first reimbursement coverage announcement. (Mass Device)

Medicare Administrator in New England and the Midwest Will Reimburse Posterior Tibial Nerve Stimulation for Overactive Bladder

Aug. 11, 2014 - Uroplasty, Inc. announced a positive coverage decision for its device that delivers posterior tibial nerve stimulation to treat symptoms of overactive bladder. The decision from National Government Services, a Medicare administrative contractor, applies to approximately 10 million Medicare beneficiaries in the states of New York, Illinois, Massachusetts, Wisconsin, Minnesota, Connecticut, Maine, New Hampshire, Rhode Island and Vermont. The company said it will increase its marketing to those areas. (Wall Street Journal)

Neuromodulation Recipients Are Among Long-Distance Runners for Company Race

Aug. 11, 2014 - Three patients who have deep brain stimulation implants and another who has a spinal cord stimulator are among the 25 runners who have medical technology implants and will compete as a team sponsored by Medtronic, Inc. in the Twin Cities, MN in October. Running as "Medtronic Global Heroes" the international team will compete in the Medtronic Twin Cities Marathon or TC 10 Mile on Oct. 5, 2014. (3BL Media)

Medical Center to Offer Deep Brain Stimulation for Obsessive Compulsive Disorder

Aug. 11, 2014 - The University of Pittsburgh Medical Center will be offering deep brain stimulation to certain patients who have obsessive compulsive disorder through an FDA Humanitarian Device Exemption, which generally enables patients to seek insurance coverage for the procedure. (Post-Gazette.com)

Public Media Program Features Boston-Area Research Into Brain Stimulation and Decision-Making

Aug. 7, 2014 - The Boston public radio station features reporting about research into decision-making and brain stimulation. An application of the research may be to help veterans with traumatic brain injuries who have difficulty weighing cost-benefit decisions, according to one researcher interviewed who is studying stimulation to the dorsolateral prefrontal cortex. (WBUR)

Children's Hospital Adds Sacral Neuromodulation Capability

Aug. 8, 2014 - International Neuromodulation Society member Steven Teich, MD was interviewed about a new pediatric sacral neuromodulation implant service offered by the Surgical Neuromodulation Program at Nationwide Children's Hospital in Columbus, Ohio. The interview concerned the case of a 16-year-old Northern California girl who had had to use a permanent tube in her abdomen to flush her digestive system with a saline solution in an often-painful and time-consuming process. The news coverage says the device "addresses communication problems between the brain and the nerves that control bowel and bladder function." For an average patient, it may take 6-12 months to have the colon begin functioning more normally. (WFMZ-TV)

Neuromodulation Company Completes Its Acquisition of a Private Manufacturer of Pain Interventions

Aug. 7, 2014 - St. Jude Medical, Inc. announced it has completed its acquisition of privately held NeuroTherm, Inc., a manufacturer of interventional pain management therapies. The acquisition for approximately $200 million was announced initially in July. (Fierce Medical Devices)

Article Sees Bright Future for Electrical Implants

Aug. 7, 2014 - An article about the newly emerging field of electroceuticals mentions a recently approved neurostimulation device for obstructive sleep apnea (as well as other neuomodulation products under development) and predicts, "Within a decade or two, electrical implants could treat a wide range of common conditions." (Newsweek)

Add-on Payment for Medicare Coverage Approved for Closed-Loop Device for Epilepsy

Aug. 6, 2014 - NeuroPace, Inc. received approval from the Centers for Medicare & Medicaid Services for a New Technology Add-on Payment (NTAP) for its RNS® System, a responsive neurostimulation system that uses closed-loop feedback as an adjunctive control for some types of medically refractory epilepsy. The NTAP program is designed to support timely access to innovative technologies for Medicare beneficiaries. (Biospace)

Sinus-Cavity-Based Stimulation Device is Under Consideration as a Potential Approach to Treating Alzheimer's Disease

Aug. 5, 2014 - Wedge Therapeutics, a privately held medical device development company in St. Paul, Minn., acquired technology for minimally invasive brain stimulation using a sinus cavity device, a sphenoid and olfactory nerve stimulation system (SONS), in 2013. To explore its potential application in treatment for Alzheimer's disease, the company is currently seeking investment and industry partnerships. (Business Wire)

Intrathecal Baclofen's Role in Regulatory Circuits Investigated

August 2014 - International Neuormodulation Society members Damianos Sakas, MD, PhD, and Stylianos Gatzonis, MD, are among the co-authors of an article describing the impact of intrathecal baclofen (ITB) on a neuropeptide, orexin-A, that is implicated in regulation of processes that include arousal and reward. The orexin-A levels in the cerebrospinal fluid went down in nine individuals who received ITB for hypertonia, such as spasticity associated with dystonia. (Journal of Clinical Psychopharmacology)

Review Examines Deep Brain Stimulation in Obsessive Compulsive Disorder

August 2, 2014 - International Neuromodulation Society member Veerle Visser-Vandewalle, MD, PhD, contributed to a review article about deep brain stimulation (DBS) for obsessive compulsive disorder (OCD). The article reviews 25 studies involving 99 patients and five different DBS targets, noting 200 individuals have received DBS for medically refractory OCD since 1999. The authors conclude that for treatment-refractory OCD, DBS seems relatively safe and promising although no superior target was identified, and more research is needed to personalize treatment of severely affected individuals. (BioMed Central)

Report Describes a Possibly New Stimulation Target for Medically Refractory Headache

July-August 2014 - International Neuromodulation Society member Chandan Reddy, MD, has co-authored a case report of what may be the first published report of stimulation to the great auricular nerve to treat medically refractory post-traumatic headache. (Pain Physician)

Researchers Identify Possible Biomarker for Parkinson's Disease Stimulation Target

July 30, 2014 - Microelectrode recordings may help optimize the location of deep brain stimulation for patients with Parkinson's disease, with the beta-band frequency peaks that are enhanced by the disease being recorded and weighed together to map neuroanatomical variability in patients in an off-medicine state, serving as a biomarker for the location of the subthalamic nucleus sensiorimotor neurons, according to a study of 20 patients over more than two years of follow-up. International Neuromodulation Society member Damianos Sakas, MD, PhD and co-authors validated this hypothesis by showing a statistically significant difference in maximum peaks in 9 patients who responded well to deep brain stimulation versus 11 who did not; saying that the putative biomarker could provide intra- and post-operative support in optimizing stimulation of the therapeutic target. (IEEE Journal of Biomedical and Health Informatics)

Neuromodulation is Called a Third Treatment Domain for Some Conditions

Spring 2014 - An article about non-invasive electrical stimulation for medically refractory depression or other conditions calls neuromodulation a "third domain" in addition to medicine and psychotherapy for treating difficult psychiatric conditions. (U Magazine)

Article Reviews Repetitive Transcranial Magnetic Stimulation Studies in Addiction

July 28, 2014 - In a review of 19 studies involving repetitive transcranial magnetic stimulation and addiction to tobacco, alcohol, cocaine or methamphetamine, a group of psychiatric researchers conclude that the currently experimental treatment appears to show promise. (Annals of the New York Academy of Sciences)

New Mode of Magnetic Stimulation Studied for Mood Disorders

July 28, 2014 - Low field magnetic stimulation appears to have an immediate effect on mood in study subjects with major depressive disorder or bipolar disorder, according to double-blinded research published in Biological Psychiatry involving 63 volunteers. The stimulation was administered with a portable, tabletop device designed by the study author. (Harvard Gazette)

Column Considers Challenges of Adding a Neuromodulation Device to a Psychiatric Practice

June 2014 - Adding a transcranial magnetic stimulation device to a psychiatric practice calls for skills not introduced during initial medical education, as well as ongoing device support and industry interaction, balancing business considerations with impartial assessment of clinical need, say guest columnists in an editorial in an issue of Psychiatric Annals focused on therapeutic neuromodulation. (Psychiatric Annals)

Startup Seeks Partnerships to Develop Clinical Data

July 28, 2014 - Soft, thin, stretchable leads that can be more affordably manufactured are under development by the Milan- and Berlin-based start-up WISE Srl (Wiringless Implantable Stretchable Electronics), which, in preparation for seeking CE mark approval, is looking for new partnerships with neurosurgeons focused on spinal cord stimulation and neurophysiologists focused on cortical grids recording. (Daily Buzz)

Woman Seeks Insurance Coverage for Deep Brain Stimulation for Tremor Related to Multiple Sclerosis

July 24, 2014 - A multiple sclerosis patient who was referred to deep brain stimulation for her tremor plans to appeal the decision by her insurance company to not cover costs of the procedure on the basis of not being medically necessary. (WUSA-9)

Child Who Received Auditory Brainstem Implant Now Notices Sounds

July 23, 2014 - A 3-year-old boy born deaf who became the first of 10 pediatric patients in a clinical trial of auditory brainstem implant therapy is now responding to sounds, two months after his surgery. (The Globe and Mail)

Closed-Loop Neurostimulation Device Maker Participates in Memory Research

July 22, 2014 - The maker of the first, and only, FDA-approved closed-loop responsive neurostimulation system, NeuroPace, Inc., announced its partnership with research teams at the University of Pennsylvania and the University of California, Los Angeles that are working with epilepsy patients on the Restoring Active Memory Projects of the Defense Advanced Research Projects Agency. (Digital Journal)

External Trigeminal Nerve Stimulation to Be Studied as Adjunctive Therapy in One Type of Childhood Epilepsy

July 22, 2014 - The National Institutes of Health is supporting an open-label trial of external trigeminal nerve stimulation (eTNS) in children aged 8 to 18 as adjunctive therapy for the treatment of Lennox-Gastaut Syndrome, a challenging form of childhood epilepsy. The study at the Olive View-University of California, Los Angeles Medical Center in Sylmar, CA will involve nightly stimulation using an eTNS device from NeuroSigma, Inc. (Digital Journal)

Neuroprosthetics Researcher to Head Center in Switzerland

July 18, 2014 - International Neuromodulation Society member John Donoghue, PhD, a neuroscientist at Brown University who works on brain-computer interfaces, will direct the new Wyss Center for Bio- and Neuro-Engineering in Geneva. Funded with more than $100 million from a foundation started by Hansjörg Wyss, the center will have more than a dozen labs for research such as neuroengineering and regenerative engineering. (Science)

Parkinson's Patient in the UK Describes Benefits of His Deep Brain Stimulation

July 22, 2014 - In a profile of a Parkinson's disease patient who received deep brain stimulation 13 years after his diagnosis, his neurosurgeon said that relatively few Parkinson's disease patients in the United Kingdom are offered deep brain stimulation due to lack of awareness among sufferers and throughout the medical profession. Also, a representative of the charity Parkinson's UK said disagreements about who should pay may have an impact in some areas. (Express.co.uk)

Article Considers the State-of-the-Art in Neuromodulation Methods

July 15, 2014 - An overview of therapeutic neuromodulation describes current and emerging methods of stimulating or inhibiting neurons, and concludes that there is a trend toward multimodal neuromodulation. The authors say electrical neural stimulation "remains the gold standard" in clinical use but "the days of using just electrical stimulation on its own may be numbered." (Frontiers in Neuroengineering)

Early Tests Reported Concerning Steering Technology for Deep Brain Stimulation

July 2014 - International Neuromodulation Society (INS) member Claudio Pollo, MD and colleagues report intraoperative testing of directional deep brain stimulation compared to omnidirectional stimulation in 13 patients with either Parkinson's disease or essential tremor; the first testing of directional stimulation suggested by computed models in humans. They report the therapeutic window was wider in the best direction of stimulation, while the therapeutic current threshold was lower, and call for chronic implantation to further confirm the findings. INS member Alexander Green, FRCS(SN) and Prof. Tipu Aziz published a commentary about this steering technology. (Brain)

Non-invasive Optogenetics Research Advances in Animal Studies

July 17, 2014 - Researchers at MIT are developing a light-sensitive protein in optogenetics research that, in mice, has been shown to suppress neuronal activity non-invasively, with exposure to a light source outside the brain, to a depth of up to 3 millimeters. (AANS Neurosurgeon)

Non-invasive Stimulation Studied to Improve Reasoning, Learning and Memory

July 16, 2014 - The U.S. Intelligence Advanced Research Projects Activity is funding a a three-and-a-half-year, $12.7 million program, "Strengthening Human Adaptive Reasoning and Problem-Solving," SHARP, through a Boston-based contractor, Charles River Analytics. The University of New Mexico (UNM)  and Georgia Tech are partnering to use brain-building games in combination with meditation or mindfulness training and transcranial direct current stimulation to improve memory and problem-solving. Over the months of the training in the study, progress is tracked using fMRI. A researcher at the UNM Psychology Clinical Neuroscience Center said that as the approach is developed, it might become a less-expensive alternative to pharmaceuticals to address mental conditions and try to restore more effective brain function. (Medical Xpress)

Proponent Calls for Cooperation and Collaboration in Brain-Research Efforts

July 14, 2014 - "We need to support and fund every rational strategy that could make headway in our understanding of the brain," says U.S. Rep. Chaka Fattah in a column responding to an open letter by scientists critiquing the European Union's effort to simulate the brain, the Human Brain Project. (Huffington Post)

Company Announces Device Approval in China

July 14, 2014 - Advanced Bionics said its waterproof cochlear implant, which allows users to go swimming, the Neptune, has been approved for use in China. (Mass Device)

Sister of Deep Brain Stimulation Patient Nominated for Award for Her Fundraising

July 14, 2014 - A woman who raised $18,000 for Parkinson's disease research by running a marathon after her sister's diagnosis was nominated for a Pride of Australia medal. Her sister received a deep brain stimulation impact after rigidity and tremors forced her to stop her work as a television producer. (news.com.au)

Company Broadens Its Stake in the Chronic Pain Intervention Market

July 14, 2014 - Adding to its chronic pain management portfolio, St. Jude Medical, Inc. agreed to acquire radiofrequency device-maker NeuroTherm, Inc. for approximately $200 million. St. Jude Medical described the acquisition as strengthening its position in chronic pain therapies, by becoming the only medical device manufacturer to offer radio frequency ablation products as well as spinal cord stimulation systems. The transaction is being structured so that it is expected to be complete before the fourth quarter, with some $10 - 15 million in revenue from NeuroTherm adding to St. Jude Medical's 2014 sales. (Seeking Alpha)

$22.5 Million Brain-Mapping Project Will Investigate Boosting Memory

July 9, 2014 - As part of a Defense Advanced Research Projects Agency initiative on "Restoring Active Memory" scientists and physicians at the University of Pennsylvania will be seeking biomarkers of memory by mapping brain activity of neurosurgical patients with epilepsy or Parkinson’s disease who participate in carrying out memory games as part of the study. In the four-year, $22.5 million project, patients will be recruited at the Hospital of the University of Pennsylvania and six other centers: Thomas Jefferson University Hospital, Dartmouth-Hitchcock Medical Center, Emory University Hospital, the University of Washington Medical Center, the Mayo Clinic and the National Institutes of Health Clinical Center. (Penn News)

Segment Features "Brain Radio" Technology Study

July 8, 2014 - Calling it a "stunning innovation" that is just beginning, a regional television segment features work on recording-and-stimulating brain targets in Parkinson's disease patients, which is being carried out in neuroscience research at Stanford University. The device is referred to as a "brain radio" since it can transmit information about neural activity as well as receive stimulating pulses. (KTVU)

News Feature Surveys Brain Research Providing Insight Into the Functional Basis of Memory

July 9, 2014 - International Neuromodulation Society member Ashwini Sharan, MD, was quoted in a story about brain recording in epilepsy patients to try to identify seizure origin -- evaluations that can simultaneously provide information about neural circuitry and memory. (New York Times)

External Trigeminal Nerve Stimulation Studies Presented at European Epileptology Meeting

July 8, 2014 - NeuroSigma, Inc. recapped a number of presentations made last week at the 11th European Congress on Epileptology in Stockholm, Sweden about external trigeminal nerve stimulation, which the company plans to evaluate for drug-resistant epilepsy in a pivotal clinical trial. (PR Newswire)

Device Maker Files Information Submission with the FDA

July 7, 2014 - Mainstay Medical has submitted a Pre-Investigational Device Exemption Information package to the FDA concerning the company's neurostimulation device for low back pain, ReActiv8. The submission can allow requesting feedback on a proposed study design or statistical analysis plan for an Investigational Device Exemption prior to a clinical trial to establish device safety and efficacy. (Becker's Spine Review)

External Headache Devices Now Classified as Moderate Risk by the FDA

July 7, 2014 - The FDA has downgraded external headache treatment devices from a Class III to a Class II medical device, no longer requiring premarket approval, but instead a shorter (510)k review pathway. (Mass Device)

Researchers Rule Out Gastrointestinal Transit Rate to Explain Improvements from Sacral Neuromodulation

July 4, 2014 - Small-intestine transit patterns remained steady in patients with diarrhea-predominant or mixed irritable bowel syndrome after four weeks of sacral nerve stimulation (SNS) during a small crossover trial at Aarhus University Hospital in Denmark. The researchers note that SNS helps limit frequency, urge, and time on the toilet and reason those benefits may come from moderating colorectal sensory perception. (Healio)

Non-invasive Brain Stimulation Pilot Study Planned in Treatment-Resistant Anorexia

July 2014 - A Toronto-based center is starting a clinical trial of repetitive transcranial magnetic stimulation in treatment-resistant anorexia nervosa. The pilot study targets the insula, which plays a role in perception, mood, anxiety and feeding. (Centre for Addiction and Mental Health)

Epilepsy Brain-Stimulation Study Finds Switch for Consciousness

July 2, 2014 - Researchers at the University of Washington found that stimulating the claustrum when probing the brain of an epileptic woman for the origin of her seizures led to a temporary, reversible loss of consciousness. At the same time her frontal and parietal brain regions increased synchrony of electrical activity. While the results may not be fully generalizable since she had previously had part of her hypothalamus removed, the researchers believe lower-frequency stimulation of this area may help arrest an epileptic seizure or potentially help with recovery from minimally conscious state. (New Scientist)

NIH to Invest in Organ-System Peripheral Neurostimulation Development

July 3, 2014 - The NIH is expected to announce a $248-million, 6-year electroceuticals project, tentatively called Stimulating Peripheral Activity to Relieve Conditions (SPARC), to map nerves and electrical activity of five yet-to-be-decided organ systems -- a task compared to monitoring passing cars to predict which freeway exits they will take -- and then develop disease-treating, recording-and-stimulation electrode interfaces for them. (Nature News & Comment)

Vagus Nerve Stimulation Company's Funding Round is Oversubscribed

July 1, 2014 - A funding initiative started last April by electroCore, a New Jersey-based electroceutical company, has been oversubscribed by $10 million, bringing the total investment to $50 million upon agreement of all the parties, including Merck's Global Healthcare Innovation Fund. The company's non-invasive vagus nerve stimulation device is currently in four randomized studies focused on cluster and migraine headache. The gammaCore device is CE marked in Europe for primary headache, bronchoconstriction epilepsy, gastric motility disorders, depression and anxiety. (MarketWatch)

Low-Back Pain Clinical Trial Expands to Belgium

June 30, 2014 - The Belgium Federal Agency for Medicines and Health Products has granted Mainstay Medical International plc permission to expand its clinical trial there of the ReActiv8 implantable neurostimulation device for low back pain. The clinical trial started in Australia in March 2014. (Wall Street Journal)

Guidelines for Overactive Bladder Treatment List Percutaneous Tibial Nerve Stimulation Third

June 30, 2014 - Percutaneous tibial nerve stimulation (PTNS) is listed as a third-line therapy for overactive bladder in the recently updated guidelines from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Uroplasty, Inc. announced. The company is the only manufacturer of a commercially available PTNS system, Urgent® PC. (MarketWatch)

Comparison Study Finds Burst Stimulation More Effective on Average Than Conventional Stimulation

June 26, 2014 - Burst stimulation was preferable to tonic stimulation in 102 patients who received spinal cord stimulation at a center in Belgium or one in the Netherlands. The patients had been receiving conventional (tonic) spinal cord stimulation and were either responders or had stopped responding to tonic stimulation. Of the group that no longer responded to tonic stimulation, 62.5% responded to burst stimulation, with an average pain suppression of 43%. Most responders to tonic stimulation responded further with burst stimulation, with average pain suppression in that group increasing from 50.6% to 73.6%. (Clinical Journal of Pain)

Pilot-Study Results Presented on Vagus Nerve Stimulation for Chronic Migraine

June 26, 2014 - Two posters at the American Headache Society meeting in California showed that a sham-controlled pilot study of electroCore's non-invasive vagus nerve stimulation therapy for chronic migraine met its safety endpoint and demonstrated a reduction in headache days for patients using the active device. (Digital Journal)

Sacral Neuromodulation Gains Ground with Increased Funding in the Province of Ontario

June 24, 2014 - International Neuromodulation Society member Magdy Hassouna, MD, PhD is mentioned as one of two urologic surgeons in Ontario, Canada who provides sacral neuromodulation. An increase in funding from the Ministry of Health means 120 patients a year can now be treated for symptoms of overactive bladder and other urologic dysfunctions. (Toronto Star)

Early Results Reported on New Neurostimulation Lead for Pain Control in Amputees

June 2014 - In a proof-of-concept trial of a peripheral nerve stimulator intended to be less invasive and more flexible and stretchable for use in amputees, 14 of 16 patients experienced significant pain relief in a two-week trial, according to a presentation by International Neuromodulation Society member Richard Rauck, MD, at the 2013 annual Pain Medicine Meeting of the American Society for Regional Anesthesia and Pain Medicine. (Pain Medicine News)

Review Documents Non-Motor Improvements from Deep Brain Stimulation in Parkinson's Disease

June 26, 2014 - A review of the scientific literature by a physician in Britain documents the effects of deep brain stimulation in improving non-motor symptoms, such as sleep disturbances, in addition to motor symptoms in Parkinson's disease, said to be the second most common neurodegenerative disorder in the United States. (Medical News Today)

Low-Frequency Stimulation of White-Matter Brain Tracts to Be Investigated in Temporal Lobe Epilepsy

June 25, 2014 - A clinical trial starting at the George Washington University School of Medicine in patients with temporal lobe epilepsy will explore low-frequency stimulation of a white matter tract, that includes the fornix, to see if it reduces seizures without unduly impacting memory. In a previous study that used this stimulation mode temporarily in patients being monitored prior to surgery, low-frequency stimulation reduced seizures 92% while activating the hippocampus and other areas of the declarative memory circuit. That study was published in the Annals of Neurology in 2013 by Mohamad Z. Koubeissi MD and co-authors who are members of the International Neuromodulation Society: Emine Kahriman MD; Tanvir U. Syed MD, MPH; Jonathan Miller, MD; and Dominique M. Durand, PhD. (Newswise)

Retrospective Study Fine-Tunes Target for Deep Brain Stimulation in Dystonia

June 25, 2014 - A retrospective modeling study of 21 patients with DYT1-type dystonia who responded well to deep brain stimulation indicates the optimal stimulation target was a region of 135.5 cubic millimeters within the globus pallidus -- a "target within a target". (Medical Xpress)

Television Segment Features Overactive Bladder Treatment

June 24, 2014 - A woman who has received seven of her 12 weekly treatments for overactive bladder using posterior tibial nerve stimulation says she already has stopped having to get up in the middle of the night to use the restroom. The Terre Haute, Indiana clinic where she receives her treatment has just started offering this service. (MyWaboshValley.com)

Tinnitus Patients are Sought for Clinical Trial in Detroit

June 24, 2014 - The Henry Ford Health System in Detroit is recruiting patients with tinnitus for a clinical trial that compares sham treatment to vagus nerve stimulation paired with audio therapy. After six weeks, separate active and sham treatment groups will all receive active treatment. The center is one of four worldwide carrying out the study, funded by the U.S. National Institutes of Health. (Newswise)

Child Receives Deep Brain Stimulation to Control Her Dystonia

June 23, 2014 - International Neuromodulation Society member John Honeycutt, MD, was interviewed in a television segment about a 7-year-old girl in California who received deep brain stimulation for dystonia. Her procedure was done while she was asleep, and she has been showing improvements that should continue in the months to come. (ABC30)

UK Woman Awaits Word on Request for NHS to Provide Recommended Sacral Neuromodulation

June 19, 2014 - Due to what a local health authority termed  "gaps and inconsistencies," a Nottinghamshire, UK woman who has applied three times for a sacral neuromodulation implant to help her void her bladder over the last three years is still awaiting a response to her third request to the National Health Service. The 29-year-old woman was recommended for the operation by her consultant, who said it could "transform her life," which now involves catheterizing four or more times a day. (BBC News)

Technology Allows Paralyzed Patient to Move Hand

June 24, 2014 - International Neuromodulation Society Director-at-Large Ali Rezai, MD, director of the Ohio State University Neuroscience Program, was interviewed by major news media about the first paralyzed patient to undergo a clinical trial involving technology developed by Battelle research labs to restore motion to a paralyzed hand. The technology enabled the 23-year-old patient to use an implanted microchip sensor and a "sleeve" of electrode stimulators to open and close his hand for the first time since a spine injury from a diving accident four years ago. Dr. Rezai performed the neurosurgery to place the sensor on the patient's motor cortex. The patient is the first of five potential participants in the six-month trial. His participation was described in the Washington Post. (CBS This Morning)

Five-Year Study Shows Significant Benefit of Adjunctive Vagus Nerve Stimulation in Treatment-Resistant Depression

June 23, 2014 - A five-year study of nearly 800 people with treatment-resistant depression showed that in the 494 patients who also had vagus nerve stimulation (VNS) as an adjunct to usual treatment, VNS was safe and resulted in significantly better response and remission rates than usual treatment alone. The data show a 20- to 30-point separation in response and remission between the two groups, according to the observational study presented in Florida at the American Society for Clinical Psychopharmacology Annual Meeting. (Medscape)

News Show Features Deep Brain Stimulation Patient Who Has OCD

June 23, 2014 - A man with obsessive compulsive disorder is featured in a CNN segment about deep brain stimulation that likens his condition to a "neurological hiccup". The segment follows him through post-operative programming. (CNN)

Injured Former Firefighter Becomes an Advocate for Spinal Cord Stimulation

June 22, 2014 - International Neuromodulation Society President-Elect Dr. Timothy Deer explains when to consider spinal cord stimulation (SCS) as an option for chronic pain in a news feature about a former triathlete who eventually found relief for chronic pain through SCS after a sustaining injuries in an accident that required multiple surgeries. The former firefighter was able to return to work and stop taking pain medication. (Scoop San Diego)

In a Small Randomized Controlled Clinical Trial, Most Back-Pain Patients Preferred Burst Stimulation

June 19, 2014 - International Neuromodulation Society member Stefan Schu MD, PhD and colleagues report a randomized controlled clinical trial in 20 patients who use spinal cord stimulation (SCS) for failed back surgery syndrome. In random order, for one week, the patients received 500-Hz tonic stimulation, burst stimulation, and placebo stimulation. Sixteen patients (80%) preferred the burst stimulation mode, which overall provided better pain relief and quality of life in the short term of the research study. The authors recommend expanded studies in patients who have not previously received SCS. (Neuromodulation: Technology at the Neural Interface)

Sacral Neuromodulation Offered to Children at Pediatric Hospital

June 17, 2014 - Nationwide Children's Hospital in Ohio is piloting sacral neuromodulation in children for bladder and bowel control. A 16-year-old girl's case was described in which she had a permanent implant in May. For nine years, she had been unable to attend high school and underwent strictly timed, painful colon flushes that limited her ability to participate in activities. Her doctor said it may take 6 months to 1 year for the colon to begin functioning properly. The center has used the procedure on patients who have a missing or blocked passage for elimination of stool due to congenital imperforate anus. (News-medical.net)

Repetitive Transcranial Magnetic Stimulation Study in Post-Stroke Pain Indicates Possible Brain Networks Involved

June 17, 2014 - In 14 patients with central post-stroke pain and deficits in thermal perception, five sessions of repetitive transcranial magnetic stimulation targeted to the motor region for the affected area provided moderate pain relief for up to four weeks post-treatment. The analgesia correlated with improvements in detection of warmth, indicating the treatment mechanism may share circuitry for the processing of noxious and thermal signals, such as the insula and the somatosensory and anterior cingulate cortices. (Neuromodulation: Technology at the Neural Interface)

Health Charity Brings Parkinson's Study of Deep Brain Stimulation to Parliament

June 16, 2014 - Saying "there's still a postcode lottery in the UK when it comes to accessing Parkinson's services," the health charity Parkinson's UK presented a study it funded with the Medical Research Council and the Department for Health on deep brain stimulation to the All Party Parliamentary Group on Medical Research's summer reception. (Parkinson's UK)

Survey Identifies Factors That Influence Conversion to Spinal Cord Stimulation Implants

June 13, 2014 - A national survey of rates of conversion to permanent spinal cord stimulator (SCS) implants after a percutaneous trial found that relatively younger patients, those who had commercial insurance, and patients who had not previously attempted a percutaneous SCS trial were more likely to convert to a permanent implant. Of more than 20,000 percutaneous trials from 2000-2009 surveyed in the U.S., the overall conversion rate was 41.4%, with the highest rate (44.5%) in the North-Central region and the lowest (36.1%) in the Northeast. (Neuromodulation: Technology at the Neural Interface)

Pilot Study Data Reported Regarding Spinal Cord Stimulation for Heart Failure

June 13, 2014 - The era of device therapy to modulate autonomic tone has arrived, and randomized controlled trials should help to discern the extent of the promise, according to a commentary on a report from the Heart Rhythm Society Annual Scientific Sessions regarding 17 heart failure patients who participated in a clinical trial of spinal cord stimulation (SCS). With a mean followup of 18 months, the results of the first-in-man trial of dual-targeted high-thoracic SCS for systolic heart failure demonstrated safety and improved symptoms, functional status, left ventricular function and remodeling. (Healio)

Flexible, Wireless, Sensing-and-Stimulating Electrodes to Be Prototyped in Research Collaboration

June 11, 2014 - Lawrence Livermore National Laboratory (LLNL) has received $5.6 million from the Defense Advanced Projects Research Agency as part of the agency's Systems-Based Neurotechnology Emerging Therapies (SUBNETS) program. The laboratory previously contributed to development of Second Sight Medical Products's artificial retina, and in the SUBNETS program will work with Medtronic and collaborate with the University of California, San Francisco; UC Berkeley; Cornell University' New York University; PositScience Inc. and Cortera Neurotechnologies. LLNL plans to use thin-film technology and 3D packaging to develop flexible neural interfaces with hundreds of electrodes that operate wirelessly. (Phys.org)

Friends of Trigeminal Neuralgia Patient Seek Funds for Neurostimulation Implant

June 11, 2014 - A woman who seeks an off-label neurostimulation implant to control her chronic face and head pain is the subject of a fund-raising drive to try to raise $72,000 for the procedure. She has had trigeminal neuralgia with attacks almost weekly for five years, possibly related to sinus infections and repeat surgeries. (Missoulian)

Michigan Epilepsy Patients Receive Responsive Neurostimulation Implants

June 11, 2014 - The Grand Rapids, MI-based Spectrum Health Butterworth Hospital is one of 10 U.S. centers approved to implant the new NeuroPace Responsive Neurostimulation System. The first two Michigan patients received implants there in May to control symptoms of their epilepsy. (Medical Xpress)

Cluster Headache Therapy Results Released

June 10, 2014 - In the 10-center PREVA clinical trial in Europe, after three to four weeks of non-invasive vagus nerve stimulation therapy, 45 patients with cluster headache saw their number of incidents decrease by 46.3%. Another 48 patients who were randomized to receive the best available standard of care had a decrease of 12.5%. The stimulation was delivered using the gammaCore device by New Jersey-based electroCore Medical, LLC. (News-Medical.Net)

Florida Television Station Interviews Patient Who Prefers Neurostimulation to Ongoing Painkiller Use

June 10, 2014 - International Neuromodulation Society member Louis Raso, MD, describes the advantages of a newer spinal cord stimulator system that captures back pain without paresthesia to the legs, in an interview that also features a chronic-pain patient who says he benefited from the device. (WPLG)

Study: Adjusting Pulse Width Can Limit Side Effects of Deep Brain Stimulation

June 10, 2014 - Shorter pulse widths may avoid deep-brain-stimulation-related side effects for Parkinson's disease patients, according to a 15-person clinical study in Europe that was announced at the 18th International Congress of Parkinson's Disease and Movement Disorders in Stockholm. The Boston Scientific Corporation CUSTOM-DBS study in used its Vercise DBS System, which is undergoing a U.S. clinical trial, INTREPID, for the treatment of Parkinson's disease. (MarketWatch

Developer of Transcranial Magnetic Stimulation Therapy Raises Capital
June 9, 2014 - The medical device-maker Cervel Neurotech of Redwood City, CA has raised $11.1 million and is near the close of a $11.9 million round of financing, through the sale of equity, rights, and securities. The company is developing repetitive transcranial magnetic stimulation for neurological and psychiatric disorders, in an approach that involves multiple magnetic coils to steer the magnetic field to targeted regions of the brain. (Mass Device)

Pennsylvania Women's Health Center to Offer Sacral Neuromodulation

June 9, 2014 - Following training in Washington, D.C., Virginia, Lebannon and London, an obstetrics and gynecology practitioner who joined the Women’s Health Center at Cole Memorial Hospital in Coudersport, PA offers sacral nerve stimulation for some cases of treatment-resistant urinary or fecal incontinence. (The Bradford Era)

More Spinal Cord Stimulator Patients Could be Accommodated by Newcastle-Area Clinic

June 6, 2014 - The pain management team at the Royal Victoria Infirmary of the Newcastle Hospitals NHS Foundation Trust treats some 600 patients with chronic pain who use spinal cord stimulators, but has room for at least 100 more to be referred by their general practitioner, according to a nurse consultant at the Northeast England facility. (BBC)

Magazine Publishes Experts' Roundtable Discussion of Spinal Cord Stimulation

June 2014 - Pain Medicine News has published roundtable discussion about spinal cord stimulation patient selection, imaging considerations, and advances, which was held by specialists in anesthesiology, neurosurgery, pain medicine and radiology, and moderated by the magazine at the December 2013 annual meeting of the North American Neuromodulation Society. (Pain Medicine News)

Station Features Tinnitus Patient Who Hopes to Join a U.S. Clinical Trial Involving Vagus Nerve Stimulation

June 4, 2014 - A church choir director hopes to participate in a U.S. clinical trial that combines sound therapy with vagus nerve stimulation, having already found some relief in sound therapy alone. (KFSN)

Researchers in Germany Report an Investigative Brain Stimulation Target for Severe, Refractory Tourette Syndrome

June 2, 2014 - International Neuromodulation Society member Veerle Visser-Vandewalle, MD, PhD and co-authors at the University of Cologne Department of Psychiatry and Psychotherapy report a case series of eight patients with medically intractable, severe Tourette syndrome who were treated with deep brain stimulation in the ventral anterior and ventrolateral motor part of the thalamus to improve motor and emotional stability. Follow-up of up to one year indicated these duel stimulation targets may be a valuable option with a low side-effect profile. (Biological Psychiatry)

Trade Association Will Establish an Office in Shanghai

June 3, 2014 - The medical technology trade association AdvaMed plans to open a China office where it will work on efforts to streamline China's medtech regulation, boost reimbursement and harmonize ethical standards with those in place elsewhere. AdvaMed also established a council of China representatives from several member companies. The association received official approval to open this new office in Shanghai. (Mass Device)

Clinicians Demonstrate Benefits of Directional Deep Brain Stimulation

May 30, 2014 - In the first demonstration in humans, neurologists and neurosurgeons in Switzerland and Canada report in the journal Brain that 13 deep brain stimulation patients were involved in an intraoperative double-blind pilot study that showed that when using a smaller, directional electrode for stimulation, 43% less current was required for beneficial stimulation than with omnidirectional stimulation, and the therapeutic window to achieve the stimulation target was 41% wider, although computational modeling indicated the volume of tissue activated was only 4.2 cubic mm in the directional mode, as opposed to 10.5 cubic mm in the omnidirectional mode. (Medical News Today)

Preclinical Study to Enhance Deep Brain Stimulation Identifies Neuronal Role in Stress Response

May 28, 2014 - A study of synaptic modifications in mice, published in the Journal of Neuroscience, might help to refine deep brain stimulation for depression, according to researchers at Cold Spring Harbor Laboratory. They found that neurons in the medial prefrontal cortex were more excitable in depressed mice, but harder to excite in mice that exhibited resilience to environmental stressors, and plan to look more closely into excitatory or inhibitory factors. (Scientific American)

Future Closed-Loop Brain Stimulation Systems Will Need Low-Power Embedded Microprocessors

May 27, 2014 - An electrical and computer engineering professor who heads Rice University's Realtime Neural Engineering Laboratory and is an assistant professor of neurology at Baylor College of Medicine is working on developing deep brain stimulation that uses real-time computer processing to monitor and respond to changes in the brain. He says energy demands from this more precise approach, which should limit unwanted stimulation beyond the target, is one challenge in realizing the advance. (Medical Xpress)

Pioneer in Using Functional Electrical Stimulation Holds Question-and-Answer Session

May 27, 2014 - Jennifer French, executive director of the Neurotech Network, participated over the weekend in a Reddit "Ask Me Anything" session about her use of a functional electrical stimulation system to stand and transfer after incurring a partial spinal cord injury during a 1998 snowboarding accident. (Medical Device and Diagnostic Industry)

Deep Brain Stimulation Viewed As Best of Options by Former Wales Rock Musician

May 27, 2014 - A 64-year-old former rock drummer from Wales, Pete Boot, describes how deep brain stimulation earlier this year has restored much of his mobility and should help slow the impact of the Parkinson's disease he has coped with for the past 20 years. (contactmusic.com)

Researchers Look to Light-Converting Nanoparticle to Devise Optogenetics Without Fiber Optics

May 23, 2014 - Researchers at the University of Massachusetts Medical School have received a three-year. $900,000 grant from the Human Frontiers Science Program for preclinical studies of "wireless" optogenetics in mice and fruit flies. The researchers will use a new nanoparticle that can convert infrared light to blue light, in lieu of needing fiber optics to deliver a light pulse. (R&D Magazine)

Engineers Publish A Way to Power Microstimulators Wirelessly

May 23, 2014 - A Stanford University electrical engineering team has published in the Proceedings of the National Academy of Sciences their results showing that a 2mm-long microstimulator deep within tissue can be powered at what is deemed to be safe exposure levels by using a flat, patterned external charger that causes radio waves to propagate in a focused fashion through tissue. The method was demonstrated in a miniaturized cardiac pacemaker in a rabbit. (R&D Magazine)

Data Analysis: Spinal Cord Stimulation is Superior but Underused for Chronic Pain of Failed Back Surgery Syndrome

May 20, 2014 - An analysis of 16,455 patients with failed back surgery syndrome (FBSS) from 2000 - 2009 showed that in the 395 who received spinal cord stimulation (SCS), they experienced lower complication rates at 90 days than the patients who underwent lumbar reoperation, and the overall cost at two years was lower. International Neuromodulation Society member Shivanand Lad, MD, PhD and co-authors conclude that although previous studies have demonstrated its superior efficacy for FBSS, SCS remains underused and warrants closer consideration for the management of chronic pain in patients with FBSS. (Spine)

Occipital Nerve Stimulation Study Presented at Physician Assistants' Annual Meeting

May 26, 2014 - A poster presented at the American Association of Physician Assistants meeting in Boston described a reduction in the severity and frequency of chronic recurring headaches in a small study of patients receiving occipital nerve stimulation in Indiana. The 17 patients had shown an improvement in symptoms through an occipital nerve block prior to stimulator implantation. The severity of headaches declined in six months from an average of 9 on a 10-point scale to 3.3. (Clinical Advisor)

Portable Transcranial Magnetic Stimulation Device Receives Food and Drug Administration Approval

May 23, 2014 - Maryland-based eNeura announced it received FDA approval for its handheld SpringTMS system to relieve pain from migraines preceded by an aura. When users feel a migraine coming on, the mobile magnetic stimulator is held to the back of the head to temporarily depolarize nerve cells in the occipital lobe. Use of the device led to 38% of patients being pain-free within 2 hours of using the device, compared with only 17% of patients in the control group, in double-blind, placebo-controlled studies of more than 200 patients. (Mass Device)

Stroke Rehabilitation Study Using Magnetic Brain Stimulation Expands to More U.S. Centers

May 22, 2014 - Use of externally applied magnetic brain stimulation during occupational therapy for stroke rehabilitation helped 80% of patients regain use of their arm and hand, which was 30% more than possible with standard therapy, according to a pilot study of 30 patients at the Rehabilitation Institute of Chicago. The study, which directs the brain stimulation using navigated GPS-like tracking created by Nexstim Corporation, has been expanded after its initial six months to include 12 more centers in the U.S. (PR Newswire)

Journal Article Analyzes Media Coverage of Transcranial Direct Current Stimulation

May 22, 2014 - Only 8 out of 218 popular news articles about transcranial direct current stimulation mention its possible adverse effects, or advised caution, according to an analysis by researchers at the Institut de Recherches Cliniques de Montreal, which was published in Neuron. The authors make recommendations for a more balanced public discussion and view of the non-invasive stimulation, which has been presented in some news accounts as a potentially affordable, and even homemade, approach to cognitive enhancement. (Medical Xpress)

Interview Focuses on the Head of a Firm That Developed Non-invasive Vagus Nerve Stimulation

May 24, 2014 - ElectroCore Medical's CEO, J.P. Errico, discussed the company's external, non-invasive vagus nerve stimulation system and evolution from an acute, self-administered therapy for bronchoconstriction during an asthma attack to other uses, such as cluster headache, migraine, and potentially also pain, sleep disorders, and depression and anxiety. (Medgadget)

U.S. Patent Issued for Nerve-Blocking Technology

May 22, 2014 - Neuros Medical, Inc. announced it received a new U.S. patent for application of high-frequency electrical nerve block technology in nerves from 3mm - 12mm wide, with broad claims for treating pain, spasticity, and bladder dysfunction. Neuros now has three issued patents in its portfolio, with others pending. (Business Wire)

Experts Note Significance of Data on Spinal Cord Stimulation Wait Times

May 21, 2014 - Appropriate patient selection and referral to evaluation for spine surgery or pain medicine specialists should help to shorten wait times for spinal cord stimulation (SCS) and improve its chance of success, experts commented in an article about a poster at the American Academy of Pain Medicine 2014 annual meeting by Drs. Syed Rizvi and Krisha Kumar of the University of Saskatchewan. The poster about SCS wait times examined 437 patients and reviewed data from 443 patients. International Neuromodulation Society member Tim Deer, MD commented, "This information should encourage insurance companies to seek out centers of excellence and try to obtain access to SCS early in the severe nerve pain patient." (Pain Medicine News)

U.S. Woman Recounts Her Positive Experience with Neurostimulation for Treatment-Resistant Migraine

May 20, 2014 - International Neuromodulation Society member William Rosenberg and his patient were interviewed about neurostimulation therapy in a segment on Kansas City television. The piece reported that after a long search for an effective chronic migraine therapy, his patient received relief through occipital/peripheral nerve stimulation, which was covered by her insurance despite being off-label in the U.S. (WDAF-TV)

Physician in India Describes Parkinson's Disease Patient's Benefits From Deep Brain Stimulation

May 20, 2014 - A U.S.-trained physician in India describes how his young-onset Parkinson's disease patient was able to better manage symptoms after deep brain stimulation. (Times of India)

Neurostimulation Technologies Are Described as Showing "the Future is Now"

May 20, 2014 - Cyberonics Inc.'s AspireSR vagus nerve stimulation (VNS) system for epilepsy and Cirtec Medical Systems LLC's shrinking active-implantable devices are among the technologies presented in a column about futuristic advances that are already in implementation. The seventh-generation, wirelessly programmable VNS system with seizure response has CE mark approval and may be presented to the FDA with data from a recently completed clinical study. Meanwhile, Cirtec specializes in compact, hermetically sealed components and has provided contract services for neurostimulators targeting the brain, spinal cord, and vision restoration. (Medical Design)

Neurostimulation System for Treatment-Resistant Depression Receives Marketing Approval in Europe

May 20, 2014 - BioControl Medical of Israel announced CE mark approval in Europe for its FitNeS™ vagus nerve stimulation system for adjunctive use in treatment-resistant depression. The system applies low-amplitude stimulation to the vagus nerve to preferentially activate nerve fibers leading to the brain. (Business Wire)

Infant Said to Be Youngest to Receive Auditory Brainstem Implant in U.S. Clinical Trial

May 19, 2014 - A girl slightly less than 1 year old received an auditory brainstem implant in March as part of a clinical trial in the U.S. to investigate using the technology in young children who are not candidates for cochlear implants and never had the ability to hear. In the U.S. the implants are approved for patients aged 12 and older who have lost function of their auditory nerve due to cancer or an injury. The patient in Boston became the youngest to receive the implant as part of the clinical trial. (WBZ-TV)

Essential Tremor Patient Spreads Awareness About Deep Brain Stimulation

May 17, 2014 - A woman who benefited from deep brain stimulation for her essential tremor now gives talks to second-year medical students at Dartmouth College and to patient-support groups. The therapy allowed her to return to her occupation in hospital nursing. (Union Leader)

Neural Prosthetic System Under Development to Aid Movement After Partial Spinal Cord Injury

May 16, 2014 - The NEUWalk project in Europe has received some 9 million euros for research into an implanted microelectrode array that stimulates nerve roots in the spine to aid locomotion. The neural prosthetic system incorporates sensing microelectrodes and microprocessing. Two patients who have partial spinal cord injury are due to receive a tailored version of the device in the summer prior to a potential larger clinical trial. The preclinical version of the technology will be shown at the Sensor + Test measurement fair in Nürnberg, Germany June 3 - 5. The researchers believe such a system may have an application in Parkinson's disease as well. (News-Medical.net)

Voiding Dysfunction Company Reports Quarterly and Fiscal 2014 Results

May 15, 2014 - Uroplasty, Inc. reported increased revenues for the fourth quarter ending March 31, as well as the full fiscal year. The Minnesota-based company said sales of its Urgent® PC Neuromodulation System for voiding dysfunction were up 27% in the fourth quarter in the U.S. and 74% globally. An expansion of the marketing team led to operating expenses that contributed to a loss of $1.1 million in the fourth quarter of 2014, compared to $1 million in the fourth quarter of 2013, on total revenue of $24.6 million for the full year. (Market Watch)

Technology Publication Features Vagus Nerve Stimulation for High Blood Pressure

May 14, 2014 - Saying it may not be until 10 years that an implantable vagus nerve stimulator system for high blood pressure that was demonstrated in preclinical work is ready, an article in Medgadget points out that the approach is inviting since a renal denervation trial of Medtronic's Symplicity system failed to meet a primary efficiency endpoint in its clinical trial. (Medgadget)

Retinal Implant Company Plans an Initial Public Offering in Paris

May 13, 2014 - Pixium Vision of Paris is planning an initial public offering on Euronext Paris, a development covered in the French media, including L'Express. The company is targeting a 2015 market launch and is seeking CE mark approval for its retinal implant system, IRIS. (BioCentury)

Data Presented Comparing Medical Treatment for Depression With Transcranial Magnetic Stimulation

May 13, 2014 - A study of 306 patients with major depressive disorder showed that treatment with transcranial magnetic stimulation led to 53% reporting no or mild depression, compared to 38% of people on antidepressants reporting similar outcomes after the same length of treatment, according to a presentation at the 167th American Psychiatric Association Annual Meeting. (Time)

Brain Stimulation Study Links Oscillation Frequency With Conscious Awareness

May 11, 2014 - A sleep study with 27 healthy volunteers in Frankfurt, Germany, used transcranial alternating current stimulation (tDACS) during periods of rapid eye movement to induce self-awareness through a lucid dream state that is considered closer to consciousness, in which without awakening, subjects could control the course of their dreams. The authors of the paper in Nature Neuroscience say this is the first time that stimulation (applied between the frontal and temporal regions of the brain at lower gamma frequencies of 25 and 40 Hz) linked, in a causal fashion, synchronous oscillations at that bandwidth to conscious awareness. They believe frontotemporal tACS might help restore dysfunctional brain networks involved in schizophrenia and obsessive compulsive disorder, or help patients overcome post-traumatic nightmares. (Medical Xpress)

Burst-Mode Spinal Cord Stimulation Presented at Singapore Meeting

May 9, 2014 - Burst stimulation in spinal cord stimulation was described as influencing the medial pathway and thus helping take away the salience of pain, during a presentation at the Australian and New Zealand College of Anaesthetists annual scientific meeting in Singapore by one of the developers of St. Jude Medical's Prodigy device, which was approved for sale in Europe in April. At the same meeting,  the immediate past dean of the Australian and New Zealand College of Anaesthetists' Faculty of Pain Medicine said he is trying to set up a registry for neurostimulation devices. (The Age)

Selective Stimulation of Barofibers Described in Preclinical Study of Vagus Nerve Stimulation for Lowering Blood Pressure

May 8, 2014 - Scientists writing in the Journal of Neural Engineering describe proof-of-concept data from five rats for a vagus nerve stimulation cuff device, with 24 electrodes, designed to address hypertension. The prototype device includes detection and signal processing to sense barofibers and selectively stimulate them to lower blood pressure while avoiding unintentional stimulation effects such as bradycardia and bradypnea. The rats' blood pressure was adjusted to 60% and the effect lasted up to five times longer than the stimulation. (Medical Xpress)

Six-Month Followup Data Presented for Spinal Cord Stimulation Programming Software

May 8, 2014 - In 140 patients who have used the Boston Scientific Corporation Precision Spectra(TM) Spinal Cord Stimulator System for six months to control low back pain, data show significant and sustained pain relief, according to results presented at the World Institute of Pain 7th World Congress in Maastricht, The Netherlands. The system includes 3D software to guide programming of stimulation, and the clinician programmer using this software has now been launched for sale in Europe. Patients with low back pain reduced their 10-point-scale pain scores from an average 7.15 to 2. 93, while those with severe low-back pain reduced their average score from an initial baseline of 8.78 to 3.68. (Wall Street Journal)

Auditory Brainstem Implant Procedure Performed on First Pediatric Enrollee in Los Angeles

May 7, 2014 - The first preschooler has received an auditory brainstem implant in a clinical trial of up to 10 young children who do not have intact functioning cochlear nerves and so would not respond to a cochlear implant. The 3-year-old boy from Montreal was operated on in Los Angeles. After confirming his brain was responding to stimulation of the cochlear nucleus on the brainstem, his physicians plan to turn the implant on in June. The procedure has been used on people who lost hearing due to a tumor or accident, and in non-hearing patients, would be expected to help the auditory system function if it is performed while the brain is still completing its development during early childhood. (Los Angeles Times)

Pilot Study of Deep Brain Stimulation in Alzheimer's Disease Shows Progress

May 6, 2014 - A team of researchers centered in Cologne, Germany report in Molecular Psychiatry that after 11 months, four of six patients in a pilot study of mild-to-moderate Alzheimer's disease responded to bilateral deep brain stimulation to the nucleus basalis of Meynert. The Alzheimer's symptoms in these four patients remained stable or improved. The target in the medial forebrain was selected to stimulate release of acetylcholine since Alzheimer's disease is associated with loss of cholinergic neurons in this area that projects to the limbic system, which plays a role in the processing of memories. (WebMD)

Article Explores Popular Interest in Transcranial Direct Current Stimulation

May 5, 2014 - Transcranial direct current stimulation is catching the interest of hobbyists interested in pursuing cognitive gains, according to a news feature in Wired magazine. (Wired)

Implant to Treat Obstructive Sleep Apnea is Approved for Sale in the U.S.

May 5, 2014 - Inspire Medical Systems, Inc. has received FDA approval for its hypoglossal nerve stimulation system to treat a subset of patients who are unable to use continuous positive airway pressure for obstructive sleep apnea. The company was spun out of Medtronic, Inc. in 2007 and projects a U.S. market of about 400,000. Sales are expected to begin in mid-20014. (Today's Medical Developments)

China's Medical Device Market Continues to Expand

May 3, 2014 - A news feature describes how the medical device market in China is growing despite fears of intellectual property piracy. The country has shown double-digit growth in this sector, although its current market is just one-tenth the size of that in the U.S. As an example of the changes, Medtronic, Inc. began doing business in China in 1970 and opened an Innovation Center in Shanghai in 2012. Medtronic’s China revenues have grown from $50 million a decade ago to $800 million today. (Star Tribune)

Study: Shorter Longevity for Implantable Pulse Generators Used in Deep Brain Stimulation in Dystonia

May 2014 - Researchers at the University of Alabama at Birmingham have evaluated 470 consecutive Soletra implantable pulse generators and found that dystonia patients receiving pallidal deep brain stimulation needed more frequent stimulator adjustments and had a shorter longevity of their implantable pulse generator, compared to patients who received suthalamic and thalamic deep brain stimulation for Parkinson's disease or essential tremor. (Brain Stimulation)

Enrollment Complete in Clinical Trial of Deep Brain Stimulation in Alzheimer's Disease

May 1, 2014 - Toronto-based Functional Neuromodulation announced it has completed enrollment of 42 patients in a study of deep brain stimulation in mild Alzheimer's disease. The double-blind randomized controlled clinical trial, the ADvance Study, compares stimulation to the fornix with a control group of patients who receive no stimulation for 12 months, after which time the control group patients will also have their stimulators turned on. (NeuroNews)

Dystonia Patient Documents His Treatment Journey to Deep Brain Stimulation

May 1, 2014 - A dystonia patient who received deep brain stimulation to control his symptoms has produced a short film that was submitted to a competition at the American Academy of Neurology annual meeting in Philadelphia. (YouTube)

Study Shows Dopamine Drops When Stimulation is Halted in Obsessive Compulsive Disorder

April 30, 2014 - Fifteen patients who had stable obsessive compulsive disorder one year after receiving deep brain stimulation were studied with molecular brain imaging in a study in Biological Psychiatry. The imaging tracked fluctuations in the release of dopamine, which decreased after stimulation was turned off. The results suggest that enhancing striatal dopamine signaling may help relieve treatment-resistant symptoms of the disorder. (Medical Xpress)

Man Who Uses Newly Approved Visual Prosthesis Describes Its Benefits

April 30, 2014 - A man who was one of the first commercial users of Second Sight Medical's Argus II "bionic eye" visual prosthesis described how helpful it is to be able to counteract the impairment of his retinitis pigmentosa by now being able to distinguish between light and dark shapes and see contrasts. That change allows him to navigate his world much better, he said. (Mass Device)

Company Developing Back-Pain Implant Raises €18 million

April 30, 2014 - Mainstay Medical raised €18 million in an initial public offering that is said to be the first by a medical technology company to be simultaneously held in Dublin and Paris. The company makes a novel implanted device designed to stimulate muscles that stabilize the lower back, in order to treat chronic back pain. (Irish Times)

Entrepreneurs Plan a Noninvasive Approach to Cognitive Enhancement

April 30, 2014 - Halo Neuroscience plans to use a range of electromagnetic approaches, including electricity, magnetic fields, infrared light, and radio waves, for its external devices to improve cognition. The company was started by Amol Sarva, PhD and includes former NeuroPace Inc. employees Daniel Chao, MD and Brett Wingeler, PhD. The company received a $1.5 million financing round backed by venture capital investor Marc Andreessen. (The Verge)

News Coverage Presents Spinal Cord Stimulation as an Option in Chronic Back Pain

April 30, 2014 - A special report on using spinal cord stimulation for back pain says it has been around since the 1960s but it has taken off in recent years, is covered by medical insurance, and can be an option a physician might consider in cases of chronic pain. A patient who did not receive relief from repeat back surgery is profiled. (Kiii News)

Community Turns Out to Help a Patient Who Plans to Travel to Receive Deep Brain Stimulation

April 29, 2014 - Friends organized a community event to help raise money for a Parkinson's disease patient who plans to have deep brain stimulation surgery out of town, in Kansas City. For a nominal fee, 300 people donned glow-in-the-dark attire to participate in the event, which included a 1.6-mile race followed by a dance and obstacle course. (Hays Daily News)

Authors Propose Ways to Foster Research into Neurological Devices

April 22, 2014 - International Neuromodulation Society member Andre Machado, MD, PhD, and co-authors write in Neurology that "both the structure of clinical trial funding and the current regulation of device research" dissuade "formal and prospective research with novel devices or novel indications". They suggest five remedies, including combining federal grant awards with regulatory approval and providing private insurance for clinical trials. (Neurology)

Neuromodulation Sales Contribute to Company's Quarterly Earnings

April 29, 2014 - Boston Scientific Corporation reported a higher adjusted profit in the first quarter of 2014 that ended March 31, partly due to higher sales of neuromodulation and heart rhythm management devices. Net earnings for the quarter were $133 million, or 10 cents a share. (Reuters)

Neuromodulation Company Appoints Chief Commercialization Officer

April 28, 2014 - Autonomic Technologies, Inc. (ATI) has appointed Karl Schweitzer chief commercialization officer. Previously, as a vice president at Medtronic, Inc. he served on the global leadership team for Medtronic's neuromodulation business. At ATI, he will lead global sales and marketing. The company received CE marking in Europe for its treatment for cluster headache, the ATI™ Neurostimulation System. The system is now being investigated in a multi-center, randomized study for the treatment of high frequency, high disability migraine. (Market Watch)

Two Executive Roles Announced for Vagus Nerve Stimulation Firm

April 28, 2014 - Cyberonics, Inc. has named its former senior vice president of strategic planning, Rohan Hoare, PhD, to the newly created role of chief operating officer for the company's epilepsy franchise. Cyberonics announced it has also recently names O'Neill F. D'Cruz, MD as Chief Medical Officer. The announcement described technology in its pipeline of vagus nerve stimulation products that focus on epilepsy: AspireSR™ pulse generator, with seizure detection and response technology, that has been CE marked in Europe; and the Centro™ and ProGuardian™ products that are anticipated to be nearing regulatory submissions. (Market Watch)

Consortium to Study Patient Preferences in Medical Devices

April 28, 2014 - The U.S. FDA announced http://us7.campaign-archive1.com/?u=cff97b5f3bf8acc54721b83b1&id=4e3f86eea4 it has awarded the public-private Medical Device Consortium $500,000 for a 12-month study of patient preferences regarding medical devices. The consortium formed in Minneapolic in 2012 as a partnership between the FDA and the medical device industry with the intent to improve how medical device safety is regulated. (Star Tribune)

Pediatric Dystonia Patients Receive Deep Brain Stimulation

April 28, 2014 - A girl who regained mobility after receiving deep brain stimulation for dystonia sat with her mother at a news conference while the doctor described the operation. She was one of six children treated at Phoenix Children's Hospital. (KTAR)

Review: Deep Brain Stimulation Reduces Symptoms of Treatment-Resistant Obsessive Compulsive Disorder

April 25, 2014 - Five randomized controlled trials of active vs. sham deep brain stimulation in obsessive compulsive disorder (OCD) through April 2013, comprising 44 subjects, indicate that the treatment had a significantly lower mean score in symptoms, representing partial remission of treatment-resistant OCD. However, there were significant adverse effects experienced in one-third of cases (16). (Psychological Medicine)

Interviewers Assess Impact of Patient's Approach to Being Referred to Deep Brain Stimulation for Parkinson's Disease

April 25, 2014 - Researchers interviewed 39 men and eight women who received deep brain stimulation (DBS) implants at the University Hospital of Northern Sweden between 2002 - 2010, and three additional female DBS patients to achieve a more gender-balanced sample. The results suggest that many patients "have to argue and struggle with their clinicians in order to be referred to a DBS-team," the authors write. They also believe that outlook and approach may contribute to a gender-skewed distribution of treatment. (BMC Neurology)

Combined Cochlear Stimulation and Nerve Growth Factor May Enhance Hearing, Animal Study Indicates

April 24, 2014 - Researchers at the University of New South Wales carried out studies in guinea pigs to see whether gene therapy can maintain the health of auditory nerves to enhance the dynamic range of cochlear implant stimulation while permitting a lower stimulus threshold. In deaf guinea pigs, the team used the phenomenon of electrically opening pores in the nerve cells to introduce naked DNA -- without a viral vector -- that codes for production of neurotrophin. As they report in Science Translational Medicine, the nerve growth factor was seen to influence nerve regeneration, so that the auditory nerve naturally grew toward the cochlea, improving the animals' hearing. (Medgadget)

Responsive Neurostimulation Called a "Welcome New Arrival" for Treatment of Medically Refractory Epilepsy

April 22, 2014 - A two-year followup on the capability to use responsive neurostimulation (RNS) to treat refractory epilepsy indicates, two co-authors write, that "long-term RNS treatment is safe, and that efficacy improves with time. . . . RNS is a welcome new arrival in the armamentarium of epilepsy treatments." (Nature Reviews Neurology)

Retrospective Study Looks at Spinal Cord Stimulation Conversion from Percutaneous Trials

April 23, 2014 - Using data from MarketScan, a database that contains longitudinal patient billing data for 170 million patients from 2000 - 2009, a medical student reported at the recent annual meeting of the American Association of Neurological Surgeons that 41.4% of U.S. patients had opted for a permanent spinal cord implant after a percutaneous trial. Conversion rates were higher in the North-Central and Southern states as opposed to the Northeast and West. (Medscape)

Company Offers Advanced Implantable Pulse Generator for Future Neuromodulation Devices

April 23, 2014 - A new implantable pulse generator (IPG) for next-generation neuromodulation devices is now available from Massachusetts-based AdvaStim, Inc., where developers say it provides tools to explore issues of neural adaptation. The IPG has a modular platform with embedded software that allows customization of output parameters for advanced waveform modes, such as modulating current amplitude and pulse duration, and allowing for multi-channel delivery of simultaneous, sequential or independent pulse rates. The architecture enables multi-channel switching, electrode programming, response to external sensor data, and suitability for shrinking form factors. (Businesswire)

Magazine Notes Shift in Deep Brain Stimulation Acceptance

May 2014 - A news feature about deep brain stimulation highlights a neurologist-neurosurgeon team who have worked since 2002 in Florida, saying the technique is "one of the most exciting treatments in modern medicine" and "it's easy to imagine a future where brain implants may become as common as hip replacements". (Smithsonian)

Preliminary Findings Presented About Spinal Cord Stimulation System Offering Additional Contacts

April 2014 - International Neuromodulation Society member Salim Hayek, MD, PhD, presented a retrospective study at the December 2013 annual meeting of the North American Neuromodulation Society INS chapter, in which more than 200 patients were trialed with the Boston Scientific Corporation Precision Spectra spinal cord stimulation system. The system allows for up to 32 contacts -- double what was previously available. Prospective and comparative effectiveness research studies have begun, and data from a three-month followup of 32 patients showed a drop in average pain score from 7.05 to 2.96. INS member Tim Deer, MD, was quoted as commenting that the three-month findings are interesting but a cost analysis and prospective data would provide more information. 

Profile of a Stanford University Professor Recaps Milestones in Optogenetics and Brain Mapping

April 21, 2014 - A feature in the New York Times describes the development of optogenetics, and profiles one contributor to its development, the Stanford University Professor of Bioengineering and of Psychiatry and Behavioral Sciences Karl Deisseroth, MD, PhD. The article is one of four news features about brain mapping that the newspaper has published in the past year, and it also mentions brain-mapping work that his team presented at the November 2013 annual meeting of the Society for Neuroscience in San Diego. (New York Times)

Husband and Wife with Chronic Pain Both Benefit from Receiving Spinal Cord Stimulators
April 18, 2014 - A husband and wife in Indiana who are in their 50s both had spinal cord stimulation systems implanted for chronic back pain and can now live more active lives and continue working. Their provider said the effects of neuromodulation are among the most dramatic in his pain practice. (News-Sentinel)

Korean Charity Agrees to Help Finance Vagus Nerve Stimulation for Children with Medically Refractory Epilepsy

April 17, 2014 - A charity group in South Korea agreed to provide support so that children with drug-resistant epilepsy can receive vagus nerve stimulation (VNS) to limit their seizures. Up to 25 patients will be supported each year, with priority to families that cannot afford medical care. The commitment will be for up to 2 million won (approximately $2,000 in U.S. dollars) in medical bill coverage per patient. The agreement was formalized in a memorandum of understanding between a medical society, the Korean Child Neurology Society, and a charity group, the Supporters Society for Korea Parents of the Disabled Association. Since April 2013 the charity group has already enabled eight pediatric patients to receive VNS implants. (Korea Times)

News Feature Describes Deep Brain Stimulation to Manage Symptoms of Movement Disorder

April 15, 2014 - In a news feature for Parkinson's disease month, Southern Illinois University School of Medicine neurosurgeon Jeffrey Cozzens, MD, a member of the International Neuromodulation Society, is interviewed about how some 80-90% of patients who meet criteria to receive deep brain stimulation to control tremors notice some improvement, even though the disease itself can still progress. Having performed more than 350 of these surgeries over the years, he remarked that these patients are his happiest and thrilled to "get their lives back". (Devils Lake Journal)

Profile Features Patient Who Received Robotic-Assisted Deep Brain Stimulation Surgery

April 15, 2014 - In a profile of a patient who received robotic-assisted deep brain stimulation surgery for essential tremor, a physician explains that the technology allows patients to be able to move a little and be more comfortable during the surgery, as well as shortening the time it takes to perform. (Florida Times-Union)

Device Maker's Earnings Report Anticipates Neuromodulation Growth

April 16, 2014 - In its first quarter 2014 earnings report, St. Jude Medical Inc. announced net sales increased 4% over 2013. Neuromodulation product sales were flat at $99 million compared to the same quarter one year ago, but CE mark approval and European launch of the Prodigy spinal cord stimulation system was explicated to be a future driver of growth. (Medical Product Outsourcing)

Article Centers on Importance of Training in Reducing Implant Risk

April 15, 2014 - A presentation submitted to an upcoming medical meeting by International Neuromodulation Society member Shivanand P. Lad, MD concerns data from 12,300 insurance claims for spinal cord stimulation implants that indicate almost one in 100 cases show some degree of spinal cord or spinal nerve-root damage, according to an article in the Wall Street Journal. INS member and journal Editor-in-Chief Robert M. Levy, MD, PhD was attributed to say that uneven training across medical specialties and a perception that such implants are easy to perform is often at the root of surgical complications. Among other sources, the article also quotes INS member Gilbert Fanciullo, MD, director of pain medicine at the Dartmouth-Hitchcock Medical Center, about the importance for practitioners to be familiar with implantation risks. (Wall Street Journal)

Primary Head Pain Case Series Examines Combined Occipital and Supraorbital Stimulation

April 15, 2014 - International Neuromodulation Society member Shannon Hann, MD, presented a case series at the American Association of Neurological Surgeons 82nd Annual Meeting in which 14 of 20 patients with medically refractory primary headache found pain relief of more than 50% through combined neurostimulation of occipital and supraorbital nerves over a mean followup of 34 months. Patients with facial pain developed allodynia and had to have the systems removed. She said the combined stimulation bears further investigation and on average appears that it may be more effective than occipital stimulation alone. (Medscape)

Urologists Stage Debate Regarding Overactive Bladder Treatment Options

April 14, 2014 - In a urology meeting debate concerning treatment with botulinum toxin or sacral neuromodulation for overactive bladder, sacral neuromodulation advantages mentioned included that it can enhance voiding and defecation, which may also present problems in these patients. (European Association of Urology)

Irish Neuromodulation Device Company Plans Initial Public Offering

April 9, 2014 - To fund ongoing development of its chronic back pain device to stabilize muscles of the lower spine, the Irish medical device company Mainstay Medical announced it plans an initial public offered on the Euronext market in Paris and Dublin’s junior Enterprise Securities Market to raise up to €26.4 million through sale of 851,175 shares. (Irish Times)

Patient Enrollment Starts in Deep Brain Stimulation Clinical Registry

April 10, 2014 - Boston Scientific Corporation announced enrollment of the first patient in a new registry of the Vercise(TM) Deep Brain Stimulation (DBS) System in patients with Parkinson's disease. Approved  for sale in Europe, Israel, Australia and select countries in Latin America, the system offers multiple independent current control and a Zero Volt(TM) battery designed for longevity. The registry will evaluate the system's clinical outcomes and the economic value. (Wall Street Journal)

Neuromodulation Company With Noninvasive Investigational Approach to Depression Expands Its Leadership Team

April 10, 2014 - In preparation for pivotal clinical trials of its low-field magnetic stimulation therapy for depression, Tal Medical, Inc. of Boston added Jan Skvarka as president, CEO and member of the board of directors, as well as Ben Shapiro, MD, also on the board of directors. The National Institute of Mental Health selected the technology for its RAPID treatment program evaluating novel rapidly acting antidepressant treatments. The company is preparing for multi-site clinical trials led by psychiatric researcher Maurizio Fava, MD, director of the Clinical Research Program at Massachusetts General Hospital. The trial will examine the efficacy and durability of the treatment over an extended period of time in patients with major depressive disorder. (Market Watch)

U.S. Neurostimulation Market Projected to Approach $4 Billion by 2022

April 9, 2014 - The value of the U.S. neurostimulation device market will approach $4 billion by 2022, according to the Decision Resources Group, due in part to first-time demand for replacement of implantable pulse generators in new patients -- as well as anticipated growth in chronic heart failure, obesity, and epilepsy. However, market penetration is still thought to be low generally "because many referring physicians are not exposed to neurostimulation in medical school." (Digital Journal)

Business Column Expresses Optimism for Industry Due to News of Neurostimulation Aiding Spine-Injury Patients

April 9, 2014 - A column by the Motley Fool says now that three paralyzed patients were able to move limbs through a combination of spinal cord stimulation and physical therapy, there should be potential optimism for investors and patients who could anticipate growth in the neuromodulation sector. The column points out that the implanted systems were manufactured by Medtronic, Inc. and mentions the latest business developments from St. Jude Medical and Boston Scientific Corporation. (Motley Fool)

Story Features Pediatric Patient Who Received Deep Brain Stimulation for Dystonia

April 8, 2014 - International Neuromodulation Society member John Honeycutt, MD, was interviewed about a 7-year-old girl who has always had dystonia and was able to start bicycling three months after she received a deep brain stimulation implant during a relatively new "asleep" procedure. (Ivanhoe Broadcast News)

Spinal Cord Stimulation in Four Spinal Cord Injury Patients Enables Voluntary Movement After Complete Paralysis
April 9, 2014 - Spinal cord stimulation allowed four people with paraplegia to move previously paralyzed muscles, according to a news release by the National Institutes of Health, which partially funded the study along with the Christopher & Dana Reeve Foundation. The research (also covered in the Wall Street Journal and other publications) was published Tuesday in the journal Brain. "Neuromodulation of the sub-threshold motor state of excitability of the lumbosacral spinal networks was the key to recovery of intentional movement," the authors write. (Los Angeles Times)

U.S. National Radio Broadcast Features Essential Tremor

April 7, 2014 - A woman who had deep brain stimulation for essential tremor 15 years ago was featured in a radio broadcast about the condition. She said she cried when stimulation was first applied and quoted her tremors, which have returned to a small degree but do not interrupt her life anymore. (NPR)

Restrospective Study Indicates Electrode Placement Affects Outcomes of Subthalamic Nucleus Stimulation

April 4, 2014 - Twenty-seven authors of a retrospective analysis of 309 patients who received deep brain stimulation of the subthalamic nucleus (STN) for Parkinson's disease in France report in Neurology that the STN is the best target to control motor symptoms, postoperative cognitive deficit is mainly related to the surgery itself, and hypomania induced by stimulation in 19 cases appears to stem from both the disease characteristics (younger age, shorter disease duration, higher levodopa responsiveness) and a more ventral location of the electrode in the STN. (News-Medical.Net)

FDA Approves First Spinal Cord Stimulation Implantable Pulse Generator Fashioned for Noninvasive Software Upgrades

April 4, 2014 - The FDA has approved St. Jude Medical's Protégé™ implantable pulse generator for spinal cord stimulation, the first such device to allow future technology upgrades through software updates. New stimulation modes -- such as the currently investigated burst mode -- diagnostic capabilities, or other features could be accessed noninvasively, without needing surgery. The device has a seven-year warranty and 10-year projected battery life. International Neuromodulation Society member Tim Deer, MD, was the first to implant the device, the smallest in its class. “In the first 40 years of SCS we’ve seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies,” he commented. (Enhanced Online News)

Vanderbilt Research Into Early-Stage Deep Brain Stimulation in Parkinson's Disease Enters Pivotal Clinical Trial

April 3, 2014 - International Neuromodulation Society members Peter Konrad, MD, PhD, and Joseph Neimat, MD, of Vanderbilt University are part of a long-term study of deep brain stimulation (DBS) in early-stage Parkinson's disease, which has moved into a large Phase III, multi-center safety and efficacy trial. (Vanderbilt)

Former Radio Host Expresses Gratitude for Access to Deep Brain Stimulation for his Parkinson's Disease

April 2, 2014 - A former resident of the U.S. who stopped hosting a radio show after developing Parkinson's disease describes in a radio interview how he got up out of a wheelchair and strolled down a hall after his deep brain stimulation implant was activated. He said he was grateful that the government in Canada covered the cost of the therapy, voicing concern that it might have been costly for him to try to obtain in the U.S. (CBC Radio)

Review Details Expanding Uses of Peripheral Nerve Stimulation

May 2014 - International Neuromodulation Society member Teodor Goroszeniuk, MD and co-author David Pang, FRCA write in a review of peripheral neuromodulation that new technologies for more easily and safely placing electrodes percutaneously should further expand its uses; in addition to intractable headache, uses include neuropathic, visceral, cardiac, abdominal, low back and facial pain. Also under extensive investigation is its use in modulating organ function in treatment of syndromes such as epilepsy, incontinence and obesity with vagal, tibial and gastric stimulation. (Current Pain and Headache Reports)

Study Presented About Heating of Conditionally Safe Spinal Cord Stimulation Leads During MRI Full-Body Scans

April 2, 2014 - Medtronic Inc.'s principal electrical engineer, Heather Orser, PhD, presented a poster at the American Academy of Pain Medicine Annual Meeting in March regarding safety of a new full-body, conditionally MRI-safe spinal cord stimulation lead. Based on animal data and simulations of lead paths in human models -- combined with lead characterization analyses -- the results showed that the design for reduced radiofrequency-induced heating produced temperatures below 43º C for the full range of scenarios during 30 minutes of active scanning. (Healio)

Company's Progress Reflects Northern Ohio's Growing Neurostimulation Industry

April 1, 2014 - Ohio-based Neuros Medical, Inc. was featured in an article about the regional industry for electrical stimulation technology to address "spinal cord injury, stroke, bladder incontinence and chronic pain." International Neuromodulation Society member Amol Soin, MD, was quoted about a pilot study of the company's Altius high-frequency nerve block device for limiting amputation pain. He anticipated the device might be commercially available within two years. (Cleveland.com)

Florida Hospital Uses Robot-Assisted Surgery for Implanting Deep Brain Stimulation Electrodes

March 31, 2014 - The Baptist Health medical center in Jacksonville, Florida has begun using the Mazor Robotics Renaissance Guidance System to perform bilateral deep brain stimulation. A patient who received the procedure for his essential tremor described how the implant helps control his symptoms. (First Coast News)

Noninvasive Brain Stimulation Platform Allowed Further Patent Claims

 March 31, 2014 - Soterix Medical Inc. of New York City announced an allowance of patent claims for controlling the targeting of high-definition transcranial direct current stimulation. The company says its technology combines the advantages of transcranial direct current stimulation and transcranial magnetic stimulation. The non-invasive system is being trialled in applications spanning depression, pain, epilepsy and stroke rehabilitation. The company uses individualized brain current-flow modeling and patented algorithms for placing and energizing high-definition electrodes on the scalp. (Digital Journal)


Growth-Stage Company Adds Chief Medical Officer

March 31, 2014 - Nevro Corp. announced appointment of David Caraway, MD, PhD as its chief medical officer. A member of the International Neuromodulation Society, Dr. Caraway is a pain management physician who has been active in developing the field of neuromodulation. Nevro's high-frequency spinal cord stimulation system, Senza, is authorized for sale in Europe and Australia. (Digital Journal)


Researchers Watch Neuroplastic Response of Brain Networks to Cortical Stimulation

March 31, 2014 - Researchers in Japan combined repetitive transcranial magnetic stimulation and diffusion-weighted MRI to observe plasticity-related changes in brain regions that are affected through neural networks by the stimulation, but are not themselves stimulated. (Medical Xpress)


Neuromodulation Device Early Stage Company Expands Its Financial Management Team

March 28, 2014 - Los Angeles-based NeuroSigma, Inc. has expanded its management team with two former Amgen finance executives. Carl Adams, who was briefly the company's controller and vice president, was promoted to chief financial officer.Craig Rostamian was appointed vice president of Finance, where he will oversee financial planning and analysis. NeuroSigma has Health Canada and CE Mark approval to market its external trigeminal nerve stimulation system, the Monarch™ eTNS™ System, for the adjunctive treatment of drug-resistant epilepsy and major depressive disorder for adults and children 9 years and older. (Wall Street Journal)

Girls Promote Epilepsy Awareness and Discuss Vagus Nerve Stimulation

 March 28, 2014 - A student who received a vagus nerve stimulator two years ago to help control her epileptic seizures, and her younger sister, participated in an annual worldwide Purple Day campaign to raise awareness by telling of their experiences with the condition. The young woman has gone three months without a seizure and would like to be eligible for a driver's learning permit if she goes six months seizure-free. (Cowichan Valley Citizen)


Study: Disparities in Deep Brain Stimulation for Parkinson's Disease

March 2014 - An examination of  2.4 million discharges for Parkinson's disease from 2002 - 2009, conducted through hierarchical multivariate analysis of the Nationwide Inpatient Sample, showed that although 4.7% of all Parkinson's disease discharges were of African American patients, only 0.1% of the Parkinson's disease discharges among African Americans were for deep brain stimulation (DBS), indicating a disparity in access to this care. The study authors say that even though African American patients are more often discharged from urban teaching hospitals with a higher-than-average density of neurologists, the patients received disproportionately fewer DBS procedures than their non-African American counterparts. (JAMA Neurology)

France Issues Neurostimulation Health Technology Assessment
March 27, 2014 - Chronic neuropathic pain, complex regional pain syndrome, and ischemic pain are considered indications in which neurostimulation can play a treatment role, according to a health technology assessment just published by the French commission for evaluation of medical devices and health technologies. (Vidal)


Fibromyalgia Study Links Repetitive Transcranial Magnetic Stimulation to Improved Quality of Life

March 26, 2014 - In a small, double-blind study in France, 38 fibromyalgia patients either received sham stimulation or repetitive transcranial magnetic stimulation to the left primary motor cortex. After 14 stimulation sessions over 10 weeks, the patients were assessed for quality of life. In addition, PET scans were periodically performed throughout the treatment period. The study found that patients receiving active stimulation reported an improved quality of life and also had an increase in metabolism in the right limbic area. The study authors report in Neurology that the study provides Class II evidence for effectiveness of the intervention. (Health Day)


Vision-Restoration Startup Names New Chief Executive Officer and Director

March 25, 2014 - Khalid Ishaque, most recently general manager of Boston Scientific's international neuromodulation business, has been named chief executive officer and director of a Paris company that works on retinal implants to restore sight, Pixium Vision. Pixium has a surface-retinal-implant system, IRIS®, that entered a clinical trial in 2013 with initial patient data expected in 2014 to form the basis of a CE Mark application. The company is also developing a sub-retinal implant system, PRIMA™. Formed in 2011 based on research from the Vision Institute and Université Pierre et Marie Curie, the company incorporates academic research from the U.S. and Europe, and has raised €24.5m from venture capital and investment firms including Sofinnova Partners, Omnes Capital, Abingworth, Global Life Sciences Ventures, Bpifrance, Seventure and Polytechnos. (Pixium Vision) 


Neuromodulation Startup Raises $32.6 Million in Series A Funding

March 25, 2014 - Axonics Modulation Technologies of Irvine, Calif. has raised $32.6 million in a Series A preferred stock financing led by Edmond de Rothschild Investment Partners of Paris, with participation by NeoMed Management of Genveva, and Legend Capital of Beijing as well as a number of private investors. The company is developing novel implantable neuromodulation technology licensed from The Alfred Mann Foundation. Initially the company will focus on chronic pain and overactive bladder. Among the company's leaders is co-founder and medical advisor Timothy Deer, MD, a member of the International Neuromodulation Society. (Fierce Medical Devices)

Technology Assessment Forum Seeks Comment on Migraine Treatment Options

March 25, 2014 - The California Technology Assessment Forum will take written comments prior to a public meeting July 11, 2014 in Los Angeles to examine treatment options for migraine headaches, including a newly approved, hand-held device that provides transcranial magnetic stimulation. The forum is intended to provide guidance to clinicians, insurers and patients. (Institute for Clinical and Economic Review)

Firm Announces First Use of Its Technology for Asleep Deep Brain Stimulation Surgery

March 25, 2014 - Mazor Robotics Ltd. announced the first deep brain stimulation surgery using its Renaissance® Guidance System with the patient asleep. The surgeon in charge of the operation said the system allows the patient to have less anxiety and the procedure to be performed more quickly with fewer probes into the brain. The operation in Littleton, CO took place on a 65-year-old man who was recently diagnosed with Parkinson's disease. (Mazor Robotics)

U.S. Patient Describes Her Heart Failure Symptom Improvement with Vagal Nerve Stimulation Device

March 24, 2014 - A woman who is controlling heart failure symptoms with investigational use of a CardioFit (TM) vagal nerve stimulation device by BioControl Medical is interviewed on Florida television. (WJXT - Jacksonville)

Motor Cortex Stimulation Shown to Improve Training in Controlling Robotic Arm through Brain Interface

March 24, 2014 - Collaborators at the University of Tubingen and National Institutes of Health report that training healthy subjects to use a brain-machine to control a robotic arm went better with electrical stimulation to the primary motor cortex than in a control group that did not receive that stimulation. As a follow-up, the procedure will next be tested in stroke patients. (Medical Xpress)

First Patients Begin to Receive New Responsive Neurostimulation System for Epilepsy

March 24, 2014 - Epilepsy specialists and patients discuss use of NeuroPace's RNS System and the advantages of responsive neurostimulation in controlling seizure activity, compared to the previously available option of continual vagus nerve stimulation. (New York Times)


Auditory Brainstem Implants May Slowly Become Less Rare

March 24, 2014 - More investigation in Europe in patients with congenital disease or trauma led to exciting results that spurred expanded interest in the U.S. for auditory brainstem implant which has been performed about 1,000 times worldwide in the last 30 years. Centers experienced in removing acoustic neuromas -- one main reason to seek the intervention -- may offer the technology. The capability is now offered in Northern Ohio at the University Hospital Case Medical Center and at the Cleveland Clinic. The House Clinic in Los Angeles developed and honed the procedure and performed the bulk of implantations in the U.S. (Cleveland.com)


Business Column Explores Positive News of CE Mark Approval for Neuromodulation Device

March 21, 2014 - Recent CE Mark approval for St. Jude Medical's Prodigy neuromodulation device should help the company in light of declining sales of pacemakers and ICDs and competition from Medtronic, Inc. and Boston Scientific Corporation, a column in the Motley Fool says. The column mentions that the company estimates more than 1.5 billion people worldwide suffer from chronic pain, so the market for devices like the Prodigy is potentially huge. Also, the column calls neuromodulation "an up-and-coming field" in medical technology. (Motley Fool)


FDA Approves Implant for Sensorineural Hearing Loss

March 20, 2014 - The FDA approved the first implanted device for severe or profound sensorineural hearing loss -- the most common type -- for patients for whom standard hearing aids are ineffective. The device, the Nucleus Hybrid L24 Cochlear Implant system, combines elements of conventional cochlear implants and hearing aids. Manufactured by Cochlear Ltd. of Australia, the device os intended for use in just one ear to improve the ability to hear middle or high frequencies. Approval was based on a clinical study of 50 people. (Health Day)


Burst Spinal Cord Stimulation Technology Receives CE Mark Approval

March 20, 2014 - St. Jude Medical, Inc. announced CE Mark approval and European launch of its spinal cord stimulation (SCS) system, Prodigy™, that offers both tonic and burst stimulation for expanded therapy options. The rechargeable SCS system is subject to a U.S. clinical trial, SUNBURST™ (Success Using Neuromodulation with BURST) http://clinicaltrials.gov/ct2/show/NCT02011893. (St. Jude Medical)

Implants That Sense Neural Signals are Leading to Understanding of Brain Circuits

March 19, 2014 - Deep brain stimulation systems that can read out neural signals are contributing to studies into patterns that correlate with different symptoms of Parkinson's disease, potentially leading to creation of more tailored, responsive neurostimulation regimes. (Nature)

Retrospective Study Ranks Which Specialists Refer Chronic Pain Patients to Spinal Cord Stimulation the Soonest
March 18, 2014 - International Neuromodulation Society member Krishna Kumar, MD said in an interview about a retrospective study of 532 patients who received spinal cord stimulation (SCS) that while SCS should be considered within the first 12 - 16 weeks of chronic pain (prior to changes occurring within the brain) to improve success rates, referrals varied by specialty, with neurosurgeons on average referring after 2.69 years, and orthopedic surgeons and anesthesiaiologists referring after 4.30 and 4.84 years, respectively. (Medscape)

Company Ships Next-Generation Device for Diabetic Pain
March 18, 2014 - A transcutanteous electrical stimulation system designed to relieve neuropathic pain during sleep has been released in its second-generation form by NeuroMetrix, Inc. The company's Sensus (TM) pain management system is intended for diabetics who have chronic pain, such as from painful diabetic neuropathy. In its second iteration, the device is thinner than the previous device released in 2013, and has several hardware improvements. (Wall Street Journal)


Woman with Auditory Nerve Damage First in Northeast Ohio to Receive Auditory Brainstem Implant

March 13, 2014 - A woman who lost hearing due to benign tumors received an auditory brainstem implant (ABI) at University Hospitals Case Medical Center in Cleveland. In an announcement, a medical school professor was quoted as saying the effectiveness of ABI is limited. After the device is turned on in 6-8 weeks, she will undergo rehabilitation therapy to maximize the benefit of the additional sense of sound provided by the device. She was the first in Northeast Ohio to receive an ABI. Her surgeons consulted with the Los Angeles-based House Ear Clinic, which has performed the bulk of these surgeries nationally since their development in the 1970s. (Newswise)

Peripheral Nerve Stimulation Helps Man's Chronic Knee Pain

March 13, 2014 - A 42-year-old man who has suffered more than 16 years of knee pain due to accidents and osteoarthritis, considered too young to receive a joint replacement that may last only 20 years, was given a peripheral nerve stimulation implant after a successful trial. This was considered an uncommon application of the fairly common pain intervention. (Chicago Tribune)

Research Funding Announced for Study of Brain Stimulation in Stroke Rehabilitation

March 13, 2014 - The National Institute of Child Health and Human Development has given a $1.5 million grant to a faculty member at the University of Illinois at Chicago's Brain Plasticity Lab to compare gait training with or without brain stimulation in patients who have experienced a stroke. The neuromodulation treatment group will receive transcranial direct current stimulation in advance, and electrical stimulation in combination with motor training of the ankle. The investigator will also use MRI to see if there were any changes in cortical activity associated with the therapy. (Phys.org)


FDA Approves Device For Preventing Migraine Attacks

March 11, 2014 - The FDA announced it has given its first approval to a transcutaneous electrical nerve stimulation device meant to be used prior to the onset of pain -- the Cefaly headband-like device that stimulates the trigeminal nerve above the eyes. Designed to prevent migraines by being used daily for 20 minutes, the device is available by prescription, and may help patients who cannot tolerate migraine-prevention medication. Approval was based on a clinical study of 67 individuals in Belgium who experienced fewer migraines through its use, as well as a study of 2,313 users in France and Belgium, 53% of whom said they were satisfied and willing to buy the device for continued use. Cefaly is manufactured by STX-Med in Herstal, Belgium. (FDA)

Cardiologist Describes Neurostimulator Undergoing Clinical Trial in Heart Failure

March 11, 2014 - Patients who are not making progress having given current treatment a chance would be potential candidates for heart failure treatment using an implanted neurostimulator to treat the parasympathetic nervous system, a cardiologist says in a question-and-answer section accompanying an article about the first patient in Florida to receive the CardioFit™ nerve stimulator in a U.S. clinical trial of the device, which is approved for marketing in Europe. The device from Biocontrol Medical combines a sensor in the heart and stimulator on the vagus nerve. (Ivanhoe Newswire via WWSB)


High-Frequency Spinal Cord Stimulation Study Publishes Data from Two-Year Follow-up

March 11, 2014 - Twenty-four months of results were published in the March 2014 issue of Pain Medicine regarding a prospective European clinical study of high-frequency spinal cord stimulation for chronic, refractory low-back and leg pain. In the study of Nevro Corp.'s Senza system, back pain was reduced from an initial 8.4 out of 10.0 to 3.3, and leg pain was reduced from 5.4 out of 10.0 to 2.3. Of 82 patients trialed, 72 went on to permanent implants and 65 were available for a two-year follow-up. In addition to reduced pain, patients reported increased function, better sleep, and decreased opioid use. Adverse events resembled those seen with traditional spinal cord stimulation. Senza is authorized for sale in Europe and Australia, supported by European data published in Pain Medicine and in Neuromodulation: Technology at the Neural Interface in 2012. In the U.S., the system is undergoing a pivotal randomized controlled clinical trial, with enrollment completed one year ago of 241 patients at 11 pain treatment centers. (PR Newswire)

Vagus Nerve Stimulation System Company Receives Positive Investment Analysis
March 10, 2014 - An investment analyst issues a positive report on the company Cyberonics, Inc., explaining that up to one-third of epileptic patients do not respond to medication, and that the Houston, TX company's implantable vagus nerve stimulation (VNS) system for treatment-resistant epilepsy has been implanted in more than 75,000 patients since 1997. The company recently released a VNS device that activates in response to abnormal heart rhythms associated with seizures. The analyst said one study showed that in about 62 percent of activations seizures were diminished or halted, adding that the cost of the device and Medicare reimbursements are climbing, while VNS saves an estimated $60,000 in treatment-related expenses. (Investing Daily)


Patient Recruitment Starts in Australia for Clinical Trial of Novel Back-Pain Stimulator

March 10, 2014 - Australia has cleared Mainstay Medical to begin a clinical trial of an implantable neurostimulation device for chronic low back pain, ReActiv8, which stimulates nerves that contract key muscles that stimulate the lower back. Patient recruitment has begun at three clinical trial sites in Australia. In June 2013, Mainstay presented results at the world congress of the International Neuromodulation Society regarding the company's recently concluded European Feasibility Study. (Medical Device Business Review)

Transcranial Magnetic Stimulation Company Raises Private Capital in Israel

March 9, 2014 - Brainsway Ltd. has raised NIS 41 million (US $11.9 million) in a private-equity placement. The investment house Yelin Lapidot received 772,585 of the company's shares (5.48%) in the exchange. Brainsway will apply the proceeds to market expansion for its Deep TMS (transcranial magnetic stimulation) system for neurological/neuropsychiatric disorders. (Globes)

India Starts Fellowship for Affordable Medical Technology Innovation

March 8, 2014 - A technology accelerator in India, InnAccel, has started a six-month fellowship program on Affordable Innovation in Medical Technology to train engineers and product designers in medtech invention and entrepreneurship. The first three fellows are undergoing two months of clinical observation at the trauma and emergency care unit at St. Johns National Academy of Health Sciences in Bengaluru, which already has a number of med-tech start-ups and venture capitalists, as well as a presence by multinational companies like GE Healthcare, Phillips and Siemens. (Pharmabiz.com)

Pain Registry Provides Evidence for Neuromodulation Therapy

March 7, 2014 - The Partnership for Advancement in Neuromodulation has published interim results of its pain registry in early view in Neuromodulation: Technology at the Neural Interface. The data from 579 patients at 40 study sites showed patient-reported pain relief was 58% at three months, 58% at six months, and 57% at 12 months. Slight more than 47% of patients stopped or decreased opioid use, while smoking was shown to significantly attenuate pain relief. (MDLinx)


Retrospective Analysis Indicates Spinal Cord Stimulation Success Increases When Started Within Two Years

March 6, 2014 - International Neuromodulation Society member Krishna Kumar, MD, presented a poster at the annual meeting of the American Academy of Pain Medicine showing that in 443 patients with chronic pain, those who waited less than 2 years for spinal cord stimulation had a 75% success rate, compared to 15% for patients who waited 20 years,  (American Academy of Pain Medicine)

Clinical Trial Starts That Pairs Audio Tones and Vagus Nerve Stimulation to Reduce Tinnitus Symptoms

March 6, 2014 - The National Institutes of Health is starting a study that pairs vagus nerve stimulation and exposure to audio tones to try to reduce symptoms in patients who have moderate to severe tinnitus. The vagus nerve stimulation, provided by a device manufactured by MicroTransponder, Inc., is supposed to help re-wire the brain in response to the audio stimulation that is intended to reduce the perception of ringing in the ears that occurs in tinnitus. The clinical trial at four U.S. centers involves daily 2.5-hour sessions over six weeks. (Health Day)


Company Formed to Commercialize Implantable System Conducive to Infusion of Biologic Agents

March 6, 2014 - The Alfred Mann Foundation announced creation of a Minnesota-based life sciences company to commercialize an implantable infusion pump that provides capability for delivery of large molecules associated with emerging biologic therapies for neurodegenerative diseases. The new company, Medallion Therapeutics, is conducting a pivotal clinical evaluation for pre-market approval of the device in the United States, and is pursuing CE Mark certification in Europe. The foundation said in a news release that the technology is the result of more than 10 years of development, and could address unmet need and expand indications for implantable drug delivery. International Neuromodulation Society member Don Deyo, a seasoned industry executive, is chief executive officer, and Eric S. Harris, also an industry veteran, is chief commercial officer. (Jewish Business News)


Physician Describes New Experiences with Auditory Brainstem Implants in Children

March 4, 2014 - An interview, an implanting physician describes the intricacies of new work in the United States with auditory brainstem implants for children who lack the neural structures for a cochlear implant. Three pediatric patients have been implanted so far by Craig Buchman, MD, professor of Otolaryngology and Head and Neck Surgery at the University of North Carolina School of Medicine, who directs the university's Ear and Hearing Center. (Ivanhoe Newswire via My Suncoast)

Transcranial Magnetic Stimulation Research Indicates Greater Plasticity in Brains of Insomniacs

March 4, 2014 - A research study comparing the ease of training insomniacs on a motor task to controls suggests that insomniacs may have a more-plastic brain. The study used transcranial magnetic stimulation (TMS) to the motor cortex to trigger a thumb movement. Subjects were asked to learn to counter the movement. Although it was hypothesized that insomniacs would be less-rested and do more poorly, they surprisingly did better, suggesting there is an association between this plasticity and "dysregulation of arousal" seen in insomnia. Potentially TMS might be used to treat insomnia, according to the author of the study at Johns Hopkins University. (Live Science)

Texas Medical Center Initiates Study of Emerging Deep Brain Stimulation Target in Treatment-Resistant Depression

March 4, 2014 - A clinical trial is starting at the University of Texas Health Science Center at Houston in which five adults with treatment-resistant major depression will receive deep brain stimulation to the supero-lateral branch of the medial forebrain bundle, part of the brain's reward system between the limbic system and prefrontal cortex, an area that showed promise in a Bonn-based pilot study in seven patients in which preliminary findings were published in June 2013. (Newswise)


Concern About Medicare Distinctions Potentially Curbing Research into Deep Brain Stimulation

March 3, 2014 - International Neuromodulation Society member Andre Machado, MD, PhD, and co-authors point out that a centralization of Medicare reimbursement policies for investigational medical devices, instituted in January 2014, offers two investigational device exemption categories, neither of which balances well reflecting potential therapeutic risks of applying these devices to emerging targets and indications while also being conducive to investment in development of these therapies. (Journal of the American Medical Association)

Deep Brain Stimulation Associated with Neural Stem Cell Proliferation in Parkinson's Disease Patients

March 3, 2014 - A comparative post-mortem tissue examination of the brains of individuals without Parkinson's disease, those with Parkinson's disease who did not receive deep brain stimulation (DBS), and 12 patients who had idiopathic Parkinson's disease and received deep brain stimulation from 0.5 - 6 years before dying of other causes showed that there was a 2-6 fold greater cell proliferation in the subventricular zone of the lateral ventricles, an area of neural stem cell growth that lies close to the electrode trajectory, in the brains of the subjects who had DBS. The results suggest DBS may increase cellular plasticity, potentially in areas beyond the electrode location. The effects on Parkinson's disease symptoms and therapy are not clear. (PLoS ONE)

Effects of "Asleep" Deep Brain Stimulation Surgery Comparable Over Time to "Awake" Method for a Common Parkinson's Disease Brain Target

March 3, 2014 - Of 213 patients who received deep brain stimulation surgery targeting the subthalamic nucleus for management of Parkinson's disease symptoms while under general anesthesia, 188 were followed up after one year and 65 after five years. The resulting short-term and long-term motor effects were similar to intervention under local anesthesia, the authors state, and there were no more adverse effects. (Journal of Neurology, Neurosurgery & Psychiatry)


Neuromodulation: Technology at the Neural Interface Adds an Enhanced Article Web Interface

March 3, 2014 - The International Neuromodulation Society journal, Neuromodulation: Technology at the Neural Interface, has added a new Enhanced Article (HTML) viewing option, accessible for logged-in readers from the Table of Contents page, that facilitates online viewing on any mobile interface, from as small as the screen of a smart phone to larger-sized devices. Called "Anywhere Article," the capability from publisher Wiley-Blackwell also allows readers to offer feedback or suggestions about the new display option. INS and chapter members may read the journal by logging in at http://www.neuromodulation.com/login and clicking on the image of the journal at the member menu item "Read Neuromodulation Journal Online" (International Neuromodulation Society)


Researchers Describe Early-Stage Neurostimulation Research in Anorexia Nervosa

March 3, 2014 - The start of a Phase II trial of deep brain stimulation in anorexia nervosa, is described by Toronto-based researchers who have implanted 15 adults with chronic, treatment-resistant, or malignant cases of the eating disorder. Based on experience tracking response in depression to stimulation of the anterior cingulate, the team is focusing on the subcallousal cingulate of the anterior cingulate, noting that mood appears to be involved in the pathogenesis of anorexia nervosa. Another six patients have been enrolled and were awaiting surgery. (Psychiatric Times)

Biological Chemist in Munich Publishes Research Papers on Potential "Light Switches" for Sensory Processing

 March 2, 2014 - A biological chemist has developed a light-sensitive compound, DENAQ, that acts on specific ion channels in response to white light, which has allowed it to restore light-sensitivity in the eyes of blind mice. The research on electrophysiological remodeling of mouse retinal ganglion cells was published Feb. 19, 2014 in Neuron; in Angewandte Chemie on Feb. 12, 2014, his research group showed that the painkiller fentanyl, when modified with an azobenzene unit, will bind opioid receptors and change shape when exposed to different frequencies of light, activating or deactivating receptor function. (Ludwig-Maximilians-Universität München)


Study: Intensity, Not Area, of Spontaneous Neuropathic Pain Linked to Quality of Life

March 1, 2014 - International Neuromodulation Society member Kaare Meir, MD, PhD and colleagues in Denmark studied 26 chronic pain patients who received spinal cord stimulation, measuring both the area of spontaneous neuropathic pain and the pain intensity. The study found a correlation in increased quality of life with decreased pain intensity, but not with decreased area of spontaneous pain. (Clinical Journal of Pain)


Authors Give Overview of Neuromodulation Approaches in Cocaine Addiction

March 2014 - Repetitive transcranial magnetic stimulation (rTMS), deep rTMS, and deep brain stimulation are discussed as possible interventions for cocaine dependence in an article that also suggests potential genetic markers for risk and objective treatment outcome measures. (Addictive Disorders & Their Treatment)

External Brain Stimulation Elicited Brief Increase in Awareness in Brain-Injured Patients

Feb. 26, 2014 - Using low-level transcranial direct current stimulation that makes neurons more or less likely to fire, a clinical research team was able to elicit briefly increased levels in awareness in 15 of 55 study subjects who had shown fluctuating awareness ("minimally conscious state") or an ability to be aroused but not aware (vegetative state). In the crossover trial published online in Neurology, patients received 20 minutes of active or sham stimulation to the dorsolateral prefrontal cortex one day, and then crossed over to sham or active stimulation, respectively, the next. The responders included 13 brain-injury patients who were in minimally conscious state and 2 who had been classified as being in a vegetative state. (New Scientist)

Chronic Pain Advocacy Organization Re-emerges

Feb. 20, 2014 - The National Pain Foundation has re-emerged as a nonprofit organization, having transferred its assets to the American Pain Foundation in 2010, which disbanded in 2012. The National Pain Foundation announced a goal of creating a "digital footprint" of people in pain, their behaviors, treatments, and needs -- through online communities, surveys and forums. (Pain Medicine News)

Special Report Focuses on Four Global Neuromodulation Companies

Feb. 25, 2014 - Saying neuromodulation is poised for major growth in the coming years, Fierce Medical Devices provides an overview of the four main global competitors -- Medtronic, Inc., Boston Scientific Corporation, St. Jude Medical, and Cyberonics, Inc. Part of the anticipated growth, the article says, would come from wider and long-term use of neuromodulation therapies. (Fierce Medical Devicesl)

Neurostimulation Technique for Chronic Migraine to be Offered at Arizona Facility

Feb. 20, 2014 - International Neuromodulation Society member Jonathan Carlson, MD, will be offering a peripheral nerve stimulation technique for chronic migraine in the Phoenix, Arizona area, according to a news release from the Migraine Treatment Centers of America. (Digital Journal)

Vagus Nerve Stimulation in Response to Seizure Detection Receives CE Mark

Feb. 20, 2014 - Cyberonics, Inc. has received CE Mark approval for its 6th-generation generator for vagus nerve stimulation, the AspireSR generator, which provides automatic stimulation in response to detection of a seizure as indicated by an increase in heart rate. (Wall Street Journal)

Presentation Recaps Advantages of Brain Stimulation During Stroke Recovery

Feb. 20, 2014 - Stroke patients who receive brain stimulation and occupational therapy recovered more than twice the arm and hand movement six months after their stroke than those who received occupational therapy alone, according to research presented at the American Stroke Association's International Stroke Conference 2014. (Clinton Herald)

External Vagus Nerve Stimulation Company Featured in Business Column

Feb. 20, 2014 - A columnist calls electroCore's external vagus nerve stimulation system "digital health's big secret" and adds that the company is working on a screening tool to predict responders. (Forbes)

Vagus Nerve Stimulation Company Plans Business Presentations

Feb. 19, 2014 - Cyberonics, Inc.'s Chief Financial Officer Greg Browne will meet individually with investors and participate in a neuromodulation panel discussion in New York City next week. The panel takes place Feb. 26 at the Citi 2014 Global Healthcare Conference. On March 11, the company's president and chief executive officer, Dan Moore, will present at the Barclays Global Healthcare Conference in Miami, with a live audio webcast available from the company's website, http://www.cyberonics.com, at 2:30 PM Eastern Time. (Market Watch)

Researchers Look at the Role of Inflammatory Mediators in Response to Deep Brain Stimulation Surgery in Major Depression

Feb. 18, 2014 - Animal research and evaluations of patients who received deep brain stimulation for treatment resistant depression indicate that immediate symptom relief is mediated by local inflammation, suggesting that post-surgical analgesics that are not anti-inflammatory would be preferable, say researchers from the University of Cadiz, Spain. They are trying to discern the molecular effects in case the therapeutic effect can be replicated less invasively. In May 2013, the team published findings in Molecular Psychiatry, "Early responses to deep brain stimulation in depression are modulated by anti-inflammatory drugs". (Medical News Today)

Developers Announce Low-Power Circuit for Body-Area Networks

Feb. 18, 2014 - A power-efficient wireless transceiver circuit for use in body area networks for medical applications that adheres to the 400MHz-band international standard has been developed by Fujitsu Laboratories Ltd. and imec Holst Centre. Rather than require more than 12 milliwatts to monitor brainwaves or other vital signs as typically is needed, the circuit power requirements are reduced by more than a factor of 10 to 1.6mW for receiving data and 1.8mW for transmitting. (Today's Medical Developments)

Peripheral Nerve Stimulation for Chronic Headache Reviewed

Feb. 14, 2014 - In a review, the current evidence for peripheral neurostimulation is summarized for treatment of chronic migraine, trigeminal autonomic cephalagias and occipital neuralgia, and other secondary headache disorders. (Headache - The Journal of Head and Face Pain)

Transcranial Direct Current Stimulation Product Manufacturer Opens Boston-Area Office

Feb. 13, 2014 - Neuroelectrics, a Spanish spinoff of Starlab Neuroscience Research, has opened its first U.S. office, which is based at the Cambridge Innovation Center in Massachusetts, where it will be near research laboratories that may use its non-invasive brain stimulation research products, a transcranial direct current stimulation device, Starstim, and a wireless EEG brain monitoring device, Enobio. (BioFlash)

Noninvasive Brain Stimulation System Company's System is Installed in Sweden

Feb. 17, 2014 - Brainsway Ltd. announced it has installed deep transcranial magnetic stimulation systems at Karolinska University Hospital for depression treatment. The Swedish health system is public, the company noted, enabling more access to this mode of treatment than in the U.S. (Globes)

Brain-Computer Interface Award Submissions Sought

February 2014 - The International Annual BCI Award submission deadline is July 1, 2014; the award -- $3,000 -- recognizes outstanding, innovative research in brain-computer interfaces and has been supported since 2010 by the Australian BCI equipment supplier g.tec. (g.tec medical engineering GmbH)

Neuromodulation Research Grant Proposals for Parkinson's Research Due Next Month

February 2014 - Up to two years of funding for neuromodulation research into Parkinson's disease to relieve motor symptoms is offered by the Michael J. Fox Foundation for Parkinson's Research. Pre-proposals are due March 19. Ideal proposals involve clinical research or late-stage preclinical research in non-primates. The call for proposals calls deep brain stimulation a viable therapeutic option that provides benefit at low risk in appropriate patients although noting that the varying efficacy and side effects among subjects limits its full potential. (Michael J. Fox Foundation for Parkinson's Research)

Insights About Biomarkers of Depression Expand Future Treatment Options

Feb. 13, 2014 - An overview of new treatments for depression in Current Psychiatry mentions neuromodulation approaches and discusses theories about differences in neuron density; feedback pathways, and the role of stress in inflammatory response and cell turnover. (Medical Xpress)

Crossover Study Shows Benefit of Sacral Neuromodulation in Irritable Bowel Syndrome Patients Who Respond to a Percutaneous Trial

Feb. 6, 2014 - Surgeons from the Neurogastroenterology Unit at Aarhus University in Denmark report that in a randomized, controlled crossover study of sacral nerve stimulation (SNS) for irritable bowel syndrome (IBS), IBS-specific symptoms were significantly reduced during stimulation in the 21 participants, and conclude that SNS improves quality of life for highly selected IBS patients. The study subjects had a minimum baseline IBS symptom score of 40 points, reduced at least 30% during a percutaneous nerve evaluation prior to implantation. At one-year follow-up, the median IBS symptom sore had dropped from 62 to 25. (Annals of Surgery)

Authors Present 15-Year Follow-up on Prevention of Percutaneous Lead Migration

Feb. 11, 2014 - International Neuromodulation Society member Richard North, MD and co-authors report a retrospective series of patients in which percutaneous lead anchors were secured with a small amount of adhesive in 291 patients from 1998 to 2006. When one case of migration was observed involving a short anchor, from 2007 to 2013, in 142 consecutive patients, only a long anchor was used and a fascial incision was added to accommodate its tip, as well as stronger suture material. With a mean follow-up of 2.86 years, no migration was observed in the second set of patients; in the first series, over a mean follow-up of 4.75 years, 1.37% (4) patients experienced lead migration requiring revision. (Neuromodulation: Technology at the Neural Interface)

Neurostimulation Company Executive Questions Patent Infringement Proposed Bill

Feb. 11, 2014 - The CEO of Autonomic Technologies, Inc. and a patent attorney write in an opinion piece that proposed anti-patent-infringement legislation is unnecessarily too broad and could harm companies that assemble goods with components sourced from many manufacturers. The article describes the benefits of the startup company's ATI Neurostimulation System, a small implant designed to halt headache. (San Jose Mercury News)

Health Column Examines Study of Transcranial Stimulation to Improve Math

Feb. 11, 2014 - A column in the Wall Street Journal looks at research at Oxford University into whether noninvasive transcranial electrical stimulation can help improve performance in math. (Wall Street Journal)

Researcher Presents Studies Into Depression and Neuromodulation in Ireland

Feb. 11, 2014 - Biomarkers are needed to screen for patients who would be most likely to respond to deep brain stimulation (DBS) for depression, according to Helen Mayberg, MD, who spoke to the Royal College of Surgeons of Ireland. Mayberg said the treatment relieves psychic suffering so patients can be re-trained to engage in life in ways they are unused to, and that their previous therapeutic interventions continue. She said about 200 people have received DBS and about 80% of those in a clinical trial based in Atlanta have a sustained response, and 63% in a clinical trial based in Toronto have a sustained response. She also discussed her collaborations on brain imaging before and after cognitive behavioral therapy, which impacts the frontal cortex primarily, while drugs primarily impact the brain stem and limbic system. (Irish Times)

Advantages of Early Screening and Implantation Documented for Diaphragm Pacing in Spine-Injury Patients

Feb. 7, 2014 - A retrospective study in the Journal of Trauma and Acute Care Surgery of 22 spinal cord-injury patients who had received neurostimulation to aid breathing through diaphragm pacing just 40 days after injury found that 72% were able to breathe independently without a respirator after an average of 10 days. All the others had delayed or partial weaning but one who was taken off life-prolonging support after entering long-term acute care. Eight patients completely recovered the ability to breathe and the neurostimulation wires were removed. The study looked at 29 patients, seven of whom not did receive an implant because laparoscopic diaphragm mapping to electronically read diaphragm nerves showed their phrenic nerves were not intact. The Diaphragm Pacing System by Synapse Biomedical, Inc., NeuRx, has FDA humanitarian device approval for spinal cord injury patients and patients with amyotrophic lateral sclerosis. It received Health Canada approval in November 2013 for patients with ventilator-dependent spinal injury, and CE Mark approval in 2007 for diaphragm dysfunction. (Medical Express)

Medical Device Companies Eyed as Leading Health Care Sector Growth

Feb. 6, 2014 - A 32% growth in neuromodulation in the last three months of 2013 for Boston Scientific Corporation and a 6% growth in Medtronic Inc.'s most recent quarter were mentioned in a column that asks if the medical device industry is the biggest player in health care. (Motley Fool)

Pennsylvania Insurer Will Cover Percutaneous Tibial Nerve Stimulation for Urinary Symptoms

Feb. 6, 2014 - Independence Blue Cross of southeastern Pennsylvania will cover percutaneous tibial nerve stimulation for treatment of overactive bladder, device maker Uroplasty, Inc. announced. The addition of 2.2 million people covered by the carrier brings to some 150 million people who are covered by private insurance or Medicare who now have access to the therapy. (Wall Street Journal)

Analyst Examines Market Penetration of Vagus Nerve Stimulation System Device Maker

Feb. 5, 2014 - Depression is called the likely biggest incremental driver for value of shares of Cyberonics, Inc., whose vagus nerve stimulation systems are FDA-approved for treatment of epilepsy and depression. (Seeking Alpha)

News Show Features Man's Success in Quieting Tourette Syndrome Tics through Deep Brain Stimulation

Feb. 5, 2014 - International Neuromodulation Society member Brian Kopell, MD was interviewed regarding a patient whose more extreme tics caused by Tourette syndrome were quieted instantly when his deep brain stimulation system was programmed in September 2013. The patient's tics had included stumbling, punching himself in the head, and uttering profanities. A news report focused on the fact that the patient and his wife can finally go for walks while holding hands. (Good Morning America)

Meta-Analysis Shows Benefits of Deep Brain Stimulation in Parkinson's Disease

Feb. 2, 2014 - An analysis of randomized controlled trials comprising almost 1,200 patients up to April 2013 indicates that deep brain stimulation for Parkinson's disease "significantly improves patients’ symptoms, functionality and quality of life," a research team writes in The Journal of Neurology. They add that although the number of studies included (6) is small, the relatively large sample size does confirm treatment efficacy. (Journal of Neurology)

Hazard Alert Issued in Australia for Some Neurostimulation Devices Regarding Potential Loss of Stimulation, Over-Stimulation or Stimulation in the Wrong Area

Feb. 4, 2014 - In consultation with the Australian Department of Health's Therapeutic Goods Administraton, Medtronic Australasia has issued a hazard alert and recall for product correction concerning deep brain stimulation (DBS) and spinal cord stimulation (SCS) models that may pose a potential for loss of stimulation or over-stimulation or stimulation in the wrong area under certain conditions: DBS models Activa PC, Activa RC and Activa SC models 37601, 37602, 37603, 37612 (Activa SC models 37602 and 37603 are not affected by the over-stimulation or stimulation in the wrong area issue); and SCS RestoreUltra and RestoreSensor models 37712, 37714. Avoiding over-discharge is advised for reducing the likelihood of over-stimulation or stimulation in the wrong area -- patients should call 1800 688 670 if their device is over-discharged. At the next visit a software upgrade to the clinician's programmer will correct the potential loss of stimulation issue. (Australian Therapeutic Goods Administration)

Device Maker's Neuromodulation Revenue Tops 30% at the End of 2013

Feb. 4, 2014 - Boston Scientific Corporation's fourth quarter results for the three months ending Dec. 31, 2013 showed a 33% increase in the neuromodulation sector of its medical-surgerical division -- the second quarter in a row that neuromodulation revenue topped 30% -- and overall 5% operational revenue growth and 1% revenue growth on a reported basis compared to the prior year period. (Yahoo! Finance)

Medical Device Component Vendor Announces Flexible Neurostimulation Platform

Feb. 4, 2014 - Los Gatos, Calif.-based CIRTEC Medical Systems has released a development platform for neuromodulation devices, VeraSTIM, that offers 4 channels, 32 electrodes, up to 10,000 HZ frequency, remote transcutaneous charging, and multiple pulse modes (burst, ramp up, ramp down, etc.). The flexibility enables testing multiple parameters during device development. (PR Newswire)

Researcher: Preclinical Optogenetics Work in Dopamine Circuits Might Influence Other Therapies

Feb. 4, 2014 - A researcher says her optogenetics work in rats might be used to understand and possibly treat other conditions by using similar viral vectors to infuse therapeutic genes into relevant brain regions. In her research, rats sought alcohol less after low-frequency, prolonged stimulation of dopamine neurons in the ventral tegmental area led to accumulation of dopamine in the nucleus accumbens, which had been thought to play a role in regulating alcohol consumption. Conversely, inducing phasic release of dopamine with brief high-frequency stimulation did not lead to less drinking of alcohol by the rats. (State University of New York at Buffalo)

Recordings Detail Coordination of Brain Centers in Planning and Executing Gait Control

Feb. 3, 2014 - A research team that took extracellular single-unit recordings in the pedunculopontine nucleus of 10 Parkinson's disease patients during "awake" surgery for implantation of deep brain stimulators writes in Nature Neuroscience that different synchronous networks were activated during initial motor planning and actual motion, suggesting that changes in gait initiation in Parkinson's disease may result from disrupted network activity. (HealthCanal)

Parkinson's Disease Researchers See Promise in Preclinical Neurostimulation Studies

Jan. 30, 2014 - In a student newspaper interview, Duke university researchers say that dorsal column stimulation is less costly and invasive than deep brain stimulation and might be applied at an earlier stage in Parkinson's disease. Their study of long-term effects in a rat model of the disease required innovating electrode designs and surgical procedures to ensure a stable implant. The team plans to translate the neurostimulation findings soon to clinical research in patients who have Parkinson's disease. (Duke Chronicle)

Neurosurgeons Provide Access to Quality Services and Information for Parkinson's Disease Patients


Jan. 29, 2014 - International Neuromodulation Society member Gary Heit, MD, PhD, is credited with helping Kaiser Permanente in Northern California to set up an advanced deep brain stimulation (DBS) service that pinpoints brain targets using diffusion tensor imaging. One recent patient at the Redwood City, Calif.-based medical center, Darcy Blake, described having DBS that helped control her tremors from Parkinson's Disease. She has helped create online information for women with Parkinson's disease that includes an entry about a recent talk on Parkinson's Disease by INS Director-at-Large Jaimie Henderson, MD given to a support group at the Sunnyvale, Calif.-based Parkinson's Institute and Clinical Center. (Palo Alto Patch)

Dubai Becomes New Regional Base for Medical Device Firm

Jan. 29, 2014 - Medtronic has moved its regional Middle East and Africa headquarters from Beirut, Lebanon to a Dubai freezone-based complex, the DuBiotech Research Park, citing its "infrastructure, accessibility, and strategic location." (Mass Device)

Patients Start Receiving Commercial Implants of Recently Approved Visual Prosthetic

Jan. 29, 2014 - The first commercial implants of the Argus II visual prosthetic took place at the University of Michigan's Kellogg Eye Center. The device maker, Second Sight Medical, plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete about three months of rehabilitation and training. The retinal implant, approved by the FDA in 2013, is designed to enhance vision in patients who have been progressively blinded by the condition retinitis pigmentosa. (Mass Device)

Photos Posted of Hospital's Milestone Deep Brain Stimulation Procedure

Jan. 27, 2014 - A business newspaper printed a photo montage from Monday's 500th deep brain stimulation surgery at Allegheny General Hospital involving a patient with cervical dystonia. (Pittsburgh Business Times)

Studies Suggest Astrocytes' Role in Lingering Impact of Deep Brain Stimulation on Brain Circuits

Jan. 24, 2014 - A review summarizes how deep brain stimulation (DBS) may both inhibit neurons and activate axons, while also triggering cellular and molecular changes in other cells, especially astrocytes. Astrocytes apparently contribute to synaptic plasticity through potentiating or mediating long-term effects; in addition, DBS may increase activity in astrocytes of delta-opioid receptor to confer neuroprotection. (CNS Neuroscience & Therapeutics)

Executive Appointed to Help Guide Commercialization Efforts for External Trigeminal Nerve Stimulation Start-Up

Jan. 27, 2014 - NeuroSigma, Inc., a Los Angeles, Calif.-based company commercializing noninvasive trigeminal nerve stimulation for neurologic and neuropsychiatric disorders, has appointed a former marketing executive from Allergan, Inc., Gregory F. Brooks, to be senior vice president and chief commercial officer. NeuroSigma's first product, the Monarch eTNS System, is available by prescription in the European Union and Canada. (Market Watch)

Maker of Devices for Voiding Disorder Names New Executive to Oversee Product Development

Jan. 27, 2014 - Suranjan Roychowdhury, PhD, has been appointed vice president of Research & Development and Clinical Affairs, a new position at Uroplasty, Inc. designed to guide clinical trials for their pipeline of products to treat voiding dysfunctions. As a materials scientist who has held leadership roles at several medical devices companies, he holds 20 issued U.S. patents in cardiology, orthopedics, urology and drug delivery. (Wall Street Journal)

Closed-Loop, Cortical Stimulation Proposed for Parkinson's Disease

Jan. 18, 2014 - Closed-loop cortical stimulation may offer clinical benefit for treating advanced Parkinson's disease, according to authors who review the issue, including the potential of mathematical modeling to contribute to its development. (Clinical Neurophysiology)

Voiding Dysfunction Medical Device Company Reports Quarterly Earnings

Jan. 23, 2014 - Uroplasty, Inc. reported a strong fiscal 2014 third quarter ending Dec. 31, 2013. Total revenues grew 14% over the same quarter the previous year to $6.4 million. The company forecasts 25-30% revenue growth for its Urgent PC neuromodulation system in the U.S. during the fourth quarter of fiscal 2014. Operating expenses were up, $6.3 million compared to $5.5 million the same quarter last year, reflecting investment in ongoing sales training, expansion and reorganization of the sales and marketing team and programs, and the medical device tax. The company booked a non-GAAP operating loss of $0.3 million compared with $0.1 million in the third quarter a year ago. (Market Watch)

Publication Cites Spinal Cord Stimulation's Neuroprotective Effects in an Animal Model of Parkinson's Disease


Jan. 23, 2014 - A study in rats indicates that repeated spinal cord stimulation may have a neuroprotective effect that could slow progression of Parkinson's disease. In the animals, six weeks of twice-weekly treatment led to such improved symptoms of depleted dopamine as better motor skills and a reversal of significant weight loss. The treated rats had better neuron survival and a higher density of dopaminergic innervation in brain regions controlled movement. (Duke University)

Landing Science Conferences Such As the INS 13th World Congress in 2017 is Considered a Coup for an Expanded Convention Center in Edinburgh

Jan. 22, 2014 - The International Neuromodulation Society's World Congress in 2017 is mentioned as one of three science conferences from 2015 - 2017 that are considered coups for the Edinburgh, Scotland International Conference Centre whose expansion opened in May. The state-of-the-art facilities and popular and natural draw of the city were cited by an executive for the British Neuroscience Association. In 2015 its Festival of Neuroscience will coincide with the Edinburgh International Science Festival. The International Congress and Convention Association rates the Edinburgh just behind London as a U.K. conference destination and 33rd worldwide. (Edinburgh News)

Neuromodulation Devices Count Heavily in Publications' Top-Ranked New Medical Technologies

Jan. 22, 2014 - Three of Fierce Medical Devices' list of the top eight FDA medical technology approvals in 2013 are neuromodulation devices -- Second Sight's Argus II Retinal Prosthesis System, NeuroPace's antiepilepsy neurostimulation implant, and eNeura's antimigraine device. (Fierce Medical Devices)

Small Piezoelectric Power Supplies are Under Development for Medical Devices


Jan. 21, 2014 - Research in large animals, published in the Proceedings of the National Academy of Sciences, shows that piezoelectric nanoribbons of lead zirconate titanate implanted on the surface of the heart, lungs and diaphragm can generate up to eight volts of electricity under mechanical stress. The prototype device stores the electrical current in a small battery, and the senior author says the device was able to power a few off-the-shelf pacemakers. An industry observer commented that in five years, such an approach to harvesting mechanical energy of the body, for instance, in arm or leg muscles or organs that move, may drive biosensors and biodevices. (Popular Mechanics)

External Trigeminal Nerve Stimulation Studies in Epilepsy Presented

Jan. 21, 2014 - Positive results in adjunctive treatment for epilepsy using external trigeminal nerve stimulation were announced last month by NeuroSigma, Inc. at the annual American Epilepsy Society meeting. The presentations concerned 10 patients who had reduction in seizures of 30 - 50% or more after 12 weeks and 8 of whom chose to continue treatment beyond the initial 18 weeks; as well as a Phase II sub-analysis of 26 patients who experienced a mean seizure reduction of 34.4% compared to an increase of 6.6% in the control group. Patients in the sub-analysis group met inclusion criteria of having 4 - 60 seizures per month -- the same criteria as will be used in an upcoming, recently approved pivotal trial. (PR Newswire)

Review Summarizes Published Studies of Tibial Nerve Stimulation in Fecal Incontinence

Jan. 21, 2014 - International Neuromodulation Society member Charles Knowles, MBBChir, PhD and co-authors reviewed 12 published clinical studies of tibial nerve stimulation to control fecal incontinence. In a randomized controlled study and case series reports, percutaneous tibial nerve stimulation (PTNS) resulted in a weekly reduction of at least 50% in occurrences of fecal incontinence in 63-82% of patients; transcutaneous tibial nerve stimulation (TTNS) resulted in similar success in 0-45% of patients. In a randomized controlled trial of PTNS vs. TTNS vs. sham, treatment success was 82% with PTNS, 45% with TTNS, and 13% in sham. (British Journal of Surgery)

Percutaneous Tibial Nerve Stimulation for Bladder Symptoms Most Effective When a Sensory Response is Present in Patients with Multiple Sclerosis

Jan. 20, 2014 - A study of percutaneous tibial nerve stimulation in 83 patients with multiple sclerosis and lower urinary tract symptoms indicated that despite the effects of the disease on neuronal pathways, the most frequently observed perception of bladder condition was a sensory response, with or without a motor response, and this was associated with a more successful therapy outcome than motor response alone. (Multiple Sclerosis Research)

Company Seeks CE Mark for Spinal Cord Stimulation System

Jan. 20, 2014 - After filing for pre-market approval of its spinal cord stimulation system last month, Greatbatch filed a CE Mark application for the system with the German notified body TÜV SÜD America. (Mass Device)

A Medical Technology Assessment Board is Formed in India

Jan. 20, 2014 - India is setting up a Medical Technology Assessment Board to evaluate appropriateness and cost-effectiveness of available and new health technologies in the country. The board will operate within the Department of Health Research, which signed a memorandum of understanding with the National Institute of Clinical Evidence (NICE) to exchange information about regulatory procedures. Although a Parlimentary panel has asked for a timeframe for the board to become functional, the government does plan to consult like technology generators, industry, regulators, economists, user groups and experts knowledgeable about similar models from UK, Canada, Australia, Thailand etc. (Pharmabiz.com)

Percutaneous Tibial Nerve Stimulation for Bladder Symptoms Most Effective When a Sensory Response is Present in Patients with Multiple Sclerosis

Jan. 20, 2014 - A study of percutaneous tibial nerve stimulation in 83 patients with multiple sclerosis and lower urinary tract symptoms indicated that despite the effects of the disease on neuronal pathways, the most frequently observed perception of bladder condition was a sensory response, with or without a motor response, and this was associated with a more successful therapy outcome than motor response alone. (Multiple Sclerosis Research)



Cardiologist Considers Hypoglossal Nerve Stimulation for Sleep Apnea Potentially Helpful for Heart Health



Jan. 15, 2014 - Future studies of hypoglossal nerve stimulation for obstructive sleep apnea should evaluate cardiovascular outcomes, a cardiologist says in a column discussing the promising study published in the New England Journal of Medicine about the therapy. The author writes that obstructive sleep apnea worsens outcomes in heart disease, and treating the sleep disorder may help to prevent heart disease. (Everyday Health)



Health Economy Model Predicts Nerve Stimulation for Refractory Hypertension is Cost-Effective



Jan. 10, 2014 - Compared to optimal medical management, therapeutic electrical stimulation of the carotid baroreceptors in patients who have medication-resistant hypertension is projected to add 2.17 quality-adjusted life years (QALY), according to a health-economic modeling analysis published in the Journal of Hypertension. Its incremental cost-effectiveness ratio is 7,797 euros per QUALY gained in a European payer setting, well below the recognized threshold of 35,000 euros. CVRx Inc. announced the findings concerning its Barostim device. The second-generation Barostim neo is commercially available in Europe and the therapy is also subject to a pivotal clinical trial in the U.S. (Diagnostic and Interventional Cardiology)


Chief Medical Officer Will Oversee Development of Sphenopalatine Ganglion Stimulation for Chronic Headache

Jan. 20, 2014 - Autonomic Technologies, Inc. has appointed as chief medical officer Shashidhar Kori, MD. With a background in establishing and running large academic training programs in pain management, he was previously vice president of Clinical Development and Medical Affairs at Allergan and MAP Pharmaceuticals, and senior director of Clinical Development and senior medical advisor on the pain/migraine team at GlaxoSmithKline before that. He will oversee clinical trials of the ATI™ Neurostimulation System for cluster headache and migraine in the United States and in Europe. (Business Wire)



Neurology Researchers Develop Mobile Application to Facilitate Quicker Programming of Deep Brain Stimulation Systems



Jan. 16, 2014 - An iPad-based clinical decision support system in preliminary testing reduced the time to program deep brain stimulation systems more than 99% (less than two minutes, rather than four hours). The project at the Medical College of Wisconsin has received a $25,000 grant from the Clinical and Translational Science Institute of Southeast Wisconsin for a prospective randomized study in Parkinson's disease patients at Froedtert Hospital. (Medical College of Wisconsin)



New Insight Into Opioid Receptor Function May Aid Development of Pain and Mood Interventions



Jan. 14, 2014 - The doorway to treating pain and mood disorders through interfacing with opioid receptors may have widened with discovery of the architecture of a sodium channel that seems common to all three types of opioid receptors. As reported in Nature, the work was achieved by crystalizing the receptors and visualizing their structure through X-ray crystallography. (Medical News Today)


Randomized Prospective Clinical Study Favorably Compares Sacral Neuromodulation to Standard Medical Treatment


Jan. 10, 2014 - Sacral neuromodulation to manage mild symptoms of overactive bladder is superior to standard medical treatment in controlling symptoms and contributing to better quality of life, according to a six-month prospective, randomized, multicenter clinical trial. The study was sponsored by the InterStim® Therapy device maker, Medtronic, Inc. (Neurourology and Urodynamics)

TV Pain Documentary Introduces Spinal Cord Stimulation for Neuropathic Pain


Jan. 10, 2014 - Spinal cord stimulation is described as a non-drug approach to controlling back pain in a Discovery Channel documentary, "Pain Matters." (Newsmax Health)

Article Discusses Activity of Deep Brain Stimulation in Motor Disorder


January 2014 - Recent animal and human evidence strongly suggests that antidromic activation from the subthalamic nucleus desynchronizes motor cortex activity. The implications for the pathogenesis and treatment of Parkinson's disease are discussed. (JAMA Neurology)

Expert Panel on Occipital Nerve Stimulation for Medically Refractory Primary Headache Starts Today for INS Members


Jan. 13, 2014 - The International Neuromodulation Society is hosting an Expert Panel for members on occipital nerve stimulation for medically refractory primary headache, co-moderated from Jan. 13 - 27 by specialists who have published groundbreaking studies about the technique since its inception -- Prof. Peter Goadsby, MD, PhD, director of the Headache Center at the University of California, San Francisco; and Richard L. Weiner, MD, clinical associate professor of neurosurgery at the University of Texas Southwestern Medical Center and Chairman of Neurosurgery at THR Presbyterian Hospital of Dallas. (International Neuromodulation Society)

Gene Therapy Dosing Trial in Parkinson's Patients


Jan 10, 2014 - In a dosing trial involving 15 patients with advanced Parkinson's disease, researchers have injected a gene-therapy vector bilaterally into the patients' putamen to produce dopamine there. Patients who received the highest dosages had to reduce their intake of levodopa. In a publication in Lancet, the researchers report that motor scores improved at 6 and 12 months, and the therapeutic, ProSavin, was safe and well-tolerated with mild to moderate side-effects. Kyriacos Mitrophanous, head of research at Oxford BioMedica in England, the company that developed the therapy and funded the study, said he thinks the treatment will eventually outperform deep brain stimulation or levodopa. (Imperial College London)

Small-town Neuromodulation Center Has Big Plans

Jan. 9, 2014 - The Greenville Neuromodulation Center is offering distance learning to clinicians about deep brain stimulation and has opened a facility on the main street of its small hometown north of Pittsburgh, PA to bring together patients, their families, and visiting healthcare professionals, as well as facilities for treatment, diagnosis and recovery, and training and research. In addition, the center has established a teaching relationship with neuroscience students at the local Thiel College. (Keystone Edge)

Study: Neurostimulation Device for Sleep Apnea Reduced Symptoms 70%

Jan. 9, 2014 - An office-based low-magnetic-field stimulation approach to relieving depression, accidentally discovered when bipolar patients were receiving MRIs 12 years ago, has become the first to be selected for a 90-day proof-of-concept trial under the NIH's Rapidly Acting Treatments for Treatment Resistant Depression program, according to the company, Tal Medical of Boston. Tal (Hindi for rhythm) believes the oscillating magnetic field of the MRI was resetting the brain's rhythm while being too low to trigger neuron firing. The company is being incubated by PureTech Ventures of Boston. (Fierce Medical Devices)

Study: Neurostimulation Device for Sleep Apnea Reduced Symptoms 70%

Jan. 8, 2014 - Medtronic, Inc.'s spinout Inspire Medical Systems of Maple Grove, MN reported in the New England Journal of Medicine a prospective study of 126 patients with obstructive sleep apnea in whom symptoms of interrupted breathing at night dropped some 70% within a year of being implanted with a hypoglossal nerve stimulator. The company is scheduled to present the device for FDA review next month. The implant was studied in patients who had trouble accepting or adhering to the current standard treatment, a sleep mask called a continuous positive airway pressure device, or CPAP. (MedPage Today)

Magnetic Field Treatment Approach to Depression Will Enter a Fast-Tracked Proof-of-Concept Trial

Jan. 8, 2014 - Medtronic, Inc.'s spinout Inspire Medical Systems of Maple Grove, MN reported in the New England Journal of Medicine a prospective study of 126 patients with obstructive sleep apnea in whom symptoms of interrupted breathing at night dropped some 70% within a year of being implanted with a hypoglossal nerve stimulator. The company is scheduled to present the device for FDA review next month. The implant was studied in patients who had trouble accepting or adhering to the current standard treatment, a sleep mask called a continuous positive airway pressure device, or CPAP. (MedPage Today)

Migraine Therapy Device Maker Receives $2.2 Million Investment

Jan. 6, 2014 - Sunnyvale, Calif.-based eNeura Therapeutics received a $2.2 million investment in late December in an equity transaction with an unnamed investor, on the heels of FDA clearance for its Cerena transcranial magnetic stimulator for migraine relief. The device is designed to be held to the back of the head to stimulate the occipital cortex when a patient senses a pre-migraine aura. (Mass Device)

Optogenetics Study Pinpoints Activity of a Brain Center in a Rat Model of Alcoholism

Jan. 3, 2014 - A low and prolonged level of dopamine release accomplished through optogenetics stopped rats from bingeing or consuming alcohol, and the cessation continued even after stimulation ended, according to a university press release about experiments reported in Frontiers in Behavioral Neuroscience. The stimulation centered on a region that was known to be activated through alcoholic behavior, the ventral tegmental area. Its role had not been clear. The study indicated that tonic, but not phasic, stimulation led to attenuated alcohol consumption by the rats. (State University of New York, Buffalo)

Medicare Recipients are Under-Represented Among Parkinson's Disease Patients Receiving Deep Brain Stimulation

Jan. 3, 2014 - An analysis of more than 665,000 Medicare recipients between 2007-2009 by collaborators at the University of Pennsylvania and Washington University in St. Louis found that patients with Parkinson's disease from lower socioeconomic strata are less likely to receive deep brain stimulation (DBS) for motor symptoms. The study, published in Neurology, states that out-of-pocket costs for DBS are 41% higher than non-DBS care, so low-income seniors may be less willing to pay the approximately $2,200 per year, and referring and treating physicians may be less likely to consider the treatment.(Medical Xpress)


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Last Updated on Monday, November 22, 2021 02:23 PM