INS 11th World Congress in Berlin
Jan. 23, 2015 - Medtronic announced a Humanitarian Device Exemption for its Enterra II neurostimulation implant for treating gastroparesis. (Mass Device)
Jan. 23, 2015 - A former biomedical engineer with Boston Scientific Corporation has created a small implanted device to stimulate nerves in the lacrimal gland to treat dry eye. After four years of work, the device is now a product-candidate undergoing clinical trials through the new company Occuleve. (Stanford Medicine)
Jan. 23, 2015 - According to the Modern Healthcare/ECRI Institute Technology Price Index, the average cost of spinal cord stimulators is now $16,957, up 8% from this time last year. The article mentions that advanced versions released in 2013 by Boston Scientific Corp. and Medtronic cost on average $19,000 while older models cost hospitals on average $13,000, although more hospitals are choosing to buy the newer devices. (Modern Healthcare)
Jan. 23, 2015 - MED-EL USA says it will launch its Synchrony cochlear implant in the U.S. following FDA approval for this model, which the company says is the only U.S.-approved one that can be used with 3.0 Tesla magnetic resonance imaging devices without surgical removal of the internal magnet. (FDA News)
Jan. 22, 2015 - Nevro Corp. announced the FDA has written to say that, subject to check-off on a number of inspection, audit, labeling, and similar compliance issues, its Senza spinal cord stimulation system is approvable under the premarket approval application, based on the application's supporting data. (PR Newswire)
Jan. 19, 2015 - Flownix Medical Inc. announced a PMA-Supplement approval from the FDA for is intrathecal Prometra® II system with a flow-activated safety valve that allows an MRI without the need to remove the drug from the reservoir in advance. (PR Newswire)
Jan. 21, 2015 - The International Neuromodulation Society 12th World Congress "Neuromodulation: Medicine Evolving Through Technology" will feature traditional and cutting-edge ways to address chronic disease through interfacing with the body’s nervous system, according to a news announcement. The event takes place June 6-11, 2015 in Montreal, Canada. (Newswise)
January 2015 - International Neuromodulation Society member Timothy Deer, MD, is quoted in an article about the Neuromodulation Appropriateness Consensus Committee guidelines that appeared in the August 2014 issue of Neuromodulation: Technology at the Neural Interface. (Anesthesiology News)
January 2015 - International Neuromodulation Society member David Provenzano, MD presented an international survey of infection-control practices during spinal cord stimulation implantation and trials. The survey was filled out by 506 respondents. In the presentation in a poster at the American Society of Regional Anesthesia and Pain Medicine 13th annual pain medicine meeting, the responses showed best practices and also areas for improvement, such as the responsibility for deep infection up to one year after implant, according to the Centers for Disease Control and Prevention definition. (Pain Medicine News)
January 20, 2015 - Ten patients with Parkinson's disease have undergone a test period of so called "noisy" electric stimulation of their balance organs (stochastic vestibular galvanic stimulation) to smooth out the effects of dopamine shortage and improve their motor skills and balance, after the concept was demonstrated in preclinical studies. The investigation in Sweden was published in the Journal Brain Stimulation. (Medical Express)
January 2015 - With volunteer effort, the collaborative neuromodulation literature database WIKISTIM is expanding to include deep brain stimulation citations as well as spinal cord stimulation citations, according to the January issue of the nonprofit organization's newsletter. (WIKISTIM)
Jan. 14, 2015 - EnteroMedics, Inc. received FDA approval for its vagus nerve stimulation therapy, VBLOC®, delivered through the Maestro® System. In an announcement, the FDA called it "the first FDA-approved obesity device since 2007," saying the device is approved for adults with a body mass index of 35 to 45 who have not been able to lose weight with a weight loss program and have at least one other obesity-related condition, such as type 2 diabetes. The approval requires a five-year post-market study of safety and effectiveness in 100 patients. (IEEE Spectrum)
Jan. 7, 2015 - Medtronic, Inc. said shareholders who have more than 75% of the stock voted in favor of its merger with Ireland-based Covidien, whose shareholders approved the deal hours earlier. The $43 billion merger should close in two weeks, turning Medtronic into an Irish-based entity, Medtronic PLC. (Mass Device)
Jan. 5, 2015 - NeuroSigma®, Inc. announced its external trigeminal nerve stimulation will be subject to a Phase II clinical trial of up to 90 children, aged 8-12, who have Attention-Deficit/Hyperactivity Disorder. The double-blind controlled trial will be supported by the U.S. National Institute of Mental Health (NIMH) and collect data on mechanism of action in alignment with the NIMH's Research Domain Criteria that emphasizes behavioral dimensions and neurobiological measures. The clinical trial will be carried out at the Semel Institute for Neuroscience and Human Behavior, located at the University of California, Los Angeles. (PR Newswire)
Jan. 4, 2015 - After a shareholder vote tomorrow on the $48 billion merger of Medtronic, Inc. and Covidien, an article in the Minneapolis Star Tribune says, Medtronic would become a new Irish-domiciled, multinational conglomerate called Medtronic PLC. Top executives will remain based in Fridley, MN. The New York Stock Exchange ticker will remain MDT, with the new shares expected to begin trading at the same price as the closing price from the day before. (Star Tribune)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Dec. 11, 2014 - Medtronic, Inc. planned to exhibit a variety of pain-control products during the North American Neuromodulation Society annual meeting, and to highlight two in particular; the high-density programming option AdaptiveStim®HD and the SureScan® spinal cord stimulation system that provides access to MRI imaging of the body under specific conditions. (Nasdaq)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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, MD, PhD; Richard North, MD; and Konstantin Slavin. MD. (A sacral nerve stimulation section editor is to be determined.) (WIKISTIM)
To see select neuromodulation news by category, as well as news about the INS in particular, please visit the Newsroom. To see archived news briefs dating back to January 2011, visit the News Archive.
How Has Neuromodulation Been Developed and Used?
Conventional medicine has typically had four modes of treating diseases or disorders: counseling or “talk therapy”; physical therapy involving manipulation and strengthening of muscles and range of motion; pharmaceuticals that act on a chemical level; and altering or augmenting tissue through surgery, injections, or filtering methods like dialysis. The growing field of neuromodulation is a new class of therapies that involves directly treating the nervous system itself, often through small implanted devices that target a specific area, to rebalance the activity of neural circuits and manage symptoms.
Progress has been spurred by advances in our understanding of the nervous system, as well as new technologies and clinical experience, enabling treatments to modify nerve cell activity in brain, spinal cord and periphery to restore function, minimize pain, and treat disease symptoms. Developed over the last 45 years, neuromodulation has grown rapidly into a family of therapies that applies stimulation or agents directly to the nervous system, often using small implanted medical devices that are powered in a similar fashion to a cardiac pacemaker. By delivering electrical or chemical stimulation, neuromodulation has increasingly been used to treat motor disorders such as Parkinson’s disease, refractory chronic pain ranging from neuropathy to cancer related pain to severe headaches, spasticity, epilepsy, and incontinence. It is also under study for conditions ranging from gastroparesis to medically refractory depression. Providers of such therapies include neurosurgeons, pain physician specialists and rehabilitation physicians. They may often work with other specialists such as neurologists, psychiatrists, psychologists, gastrointestinal or colorectal specialists, urologists, primary care physicians, and physical therapists to achieve best outcomes.
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Clinical trials that involve a wide range of emerging neuromodulation approaches are listed on our Resources and Research pages. Neuromodulator trials address symptom control through nerve stimulation in such condition categories as:
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The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation - the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its peer-reviewed journal Neuromodulation: Technology at the Neural Interface, explanatory content, and chapter websites.
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