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 National Institute of Mental Health
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Media Materials & Backgrounders
Press Releases
13 June 2013
International Panel of Expert Physicians and Neuroscientists Looks to the Future of "Digital Drugs," Implantable Devices for the Treatment of Pain - Exciting New Options Include Focus on Dorsal Root Ganglion; New Frequencies of Neurostimulation; and New Devices for Peripheral Nerve Stimulation
13 June 2013
Deep Brain Stimulation Trial in Treatment-Resistant Obesity Links Weight Loss Trend to Metabolism Increase Programmed in Metabolic Chamber
12 June 2013
Expert Panel of Physicians and Neuroscientists Announce International Guidance on Implantable Devices for the Treatment of Head and Body Pain
12 June 2013
Traumatic Brain Injury Patients Treated with Anti-Spasm Agent Partially Recover from Disorders of Consciousness
11 June 2013
Neurostimulation Helped Children’s Intractable Constipation
11 June 2013
Neuromodulation Increased Scores in Study of Impact on Sexual Dysfunction
10 June 2013
Expert Panel of Physicians and Neuroscientists Announce International Guidance on Using Neurostimulation for Chronic Pain
Expert Panel of Physicians and Neuroscientists Announce International Guidance on Using Neurostimulation to Significantly Reduce the Need for Opioids in Chronic Pain
19 April 2013
Abstract Highlights Precede June Neuromodulation Congress - International Neuromodulation Society Accepts a Record Number of Abstracts at Its 11th World Congress
10 April 2013
Innovations in Neuromodulation: Discover the latest industry trends from key opinion leaders, acquirers, and 13 early-stage companies
9 January 2013
International Neuromodulation Society 11th World Congress, Technology Transforming Chronic Illness Management, Expects 1,500 Participants in June 2013 in Berlin - The biennial scientific conference draws participants from six continents and presents the most comprehensive breadth of all neuromodulation therapies . . .
26 April 2012
International Neuromodulation Society Announces Public Education Funding - Grants from Boston Scientific, Medtronic and St. Jude Medical will help the International Neuromodulation Society (INS) develop public education materials . . .
24 Feb 2010
10 Things to Know about Neuromodulation. Minimally Invasive Procedures to Reduce or Alleviate Pain
04 Dec 2008
Largest Gathering of Neuromodulation Experts Explores Breaking Developments in Neurodevice Technologies at 12th North American Neuromodulation Society Meeting – Leading researchers and clinicians from the field of neuromodulation assembled today at the 12th annual meeting of the North American Neuromodulation Society (NANS)...
20 Feb 2008
The International Neuromodulation Society Reports Record Growth in Professional Membership and Attendance at World Congress – Milestones Parallel Major Progress in the Field of Neuromodulation...
11 Dec 2007
First Study to Reduce Depression with Cortical Neuromodulation Implant Announced at International Neuromodulation Society World Congress –Implant Designed to Deliver Electrical Pulses to Dorsolateral Prefrontal Cortex Shows Promise in Major Depression Disorder...
Significant Improvement in Post-Stroke Upper Limb Function Announced at International Neuromodulation Society World Congress
10 Dec 2007
The International Neuromodulation Society Announces Promising Results for Treating Anorexia Nervosa with Deep Brain Stimulation – Two-Year Study Reveals Effective Alternate Therapy for Devastating Eating Disorder...
03 Dec 2007
International Neuromodulation Society Announces Eighth World Congress in Acapulco, Mexico –Results to be presented from cutting-edge studies on novel treatments for depression, addiction disorders and stroke recovery... – Nerve Stimulation Results in Recovery of Arm, Hand, and Finger Movement...
06 Nov 2007
Media Alert - Neuromodulation 2007: Technology at the Neural Interface Conference –This year’s 8th World Congress of the International Neuromodulation Society (INS) will cover groundbreaking new clinical data and real-life applications for treating such diseases and impairments as Obsessive Compulsive Disorder, Depression, Stroke, Cardiac Disease, Eyesight & Hearing Loss and Paralysis using today’s newest neuromodulation therapies...
INS In the News
14 May, 2013
INS President Comments on Spinal Cord Stimulation Advantages
29 January 2013
INS President Comments on European Chronic Pain Survey
21 January 2013
INS Chapter President Leads U.S. Study of Deep Brain Stimulation in Early-Stage Alzheimer's Disease
17 January 2013
Member Discusses Deep Brain Stimulation for Parkinson's Disease
28 December 2012
Colorado Community Gains Neuromodulation Capacity with Recruitment of INS Member
17 October 2012
Member Describes Neuromodulation Therapies in NY Daily News
25 September 2012
Member Comments on New Insight Into How DBS Works
17 September 2012
Failed Back Surgery Syndrome Patient, Physician Recount Use of High-Frequency Spinal Cord Stimulation
13 Septembeer 2012
Los Angeles Times Interviews INS Member About Link from Brain Mapping to Therapy
11 September 2012
Member, Patient Discuss Her Deep Brain Stimulation for Chronic Facial Pain
6 September 2012
Member Interviewed about Israel Deep Brain Stimulation Trial in Medically Refractory Depression
5 September 2012
Member Interviewed about Brain-Computer Interfaces
28 August 2012
Argentinian Chapter Leaders to Coordinate Unique Regional Neuormodulation Program
27 August 2012
Member and Patient Discuss Her Peripheral Nerve Stimulation for Chronic Migraine
21 August 2012
Rheumatology Publication Covers Presentation by INS Member on Spinal Cord Stimulation
31 July 2012
Financial Times covers BrainGate System
12 July 2012
Member Explains Spinal Cord Stimulation in a Column in a Local Paper
9 July 2012
INS President Presents Views about Neuromodulation Benefits and Access in a United Kingdom Technology-Policy Publication
15 May 2012
INS Member Explains Deep Brain Stimulation on YouTube
3 May 2012
Neurosurgeon Who Belongs to INS Speaks on TV Show about Deep Brain Stimulation Therapy for Parkinson's Disease
April 2012
INS President Describes Benefits of Spinal Cord Stimulation in Neuropathic Pain in Publication for Healthcare Administrators
29 March 2012
Article Highlights Spinal Cord Stimulation Treatment by INS Member
28 March 2012
INS Member Featured in Article about Hard-to-Treat Headache
22 March 2012
INS Member Mentioned in Article That Describes What May Be the First Epileptic Patient to Receive Deep Brain Stimulation in India
20 March 2012
INS Member Honored by Brain Injury Association
7 March 2012
INS Leader Featured in Chicago Tribune Article about the Use of Spinal Cord Stimulation for Preventing Post-Aneurysm Stroke
23 February 2012
Science Daily Reports a Swiss Study, Involving INS Members, That Uses Sensors to Track Pain States
21 February 2012
INS Leaders Participate in a Conference about Neuromodulation for Back Pain in Ireland
1 February 2012
INS Switzerland Chapter Leader Helps Organize First Session of a Pain Management Course in Vietnam
27 December 2011
Neurosurgeon Who Belongs to the INS is Interviewed in UK Daily Mail Article about Migraine
22 December 2011
INS Leaders Featured in UK Daily Mail Story About Back Pain Relief
22 November 2011
INS Leaders are Featured in Daily Mail Article about the Use of Spinal Cord Stimulation for the Treatment of Chronic Sciatic Pain
12 September 2011
Neurotech Reports - Neurotech Startups Participate at International Neuromodulation Society Meeting
27 September 2010
The Daily Mail Online - Me and my operation: The remote control that switches off angina pain
29 Jan 2008
Virtual Medical Centre - New insights into deep brain stimulation were explored...
01 Feb 2008
Medical News Today - Promising Results For Treating Anorexia Nervosa With Deep Brain Stimulation...
Virtual Medical Centre - New insights into deep brain stimulation, an emerging therapy used to treat a number of diseases of the brain...
15 Feb 2008
Does Noninvasive Brain Stimulation Hold Promise For Treating Eating Disorders?
09 Dec 2008
Sacramento Bee - Magnets offering jolt out of dark
Click here –to view an image of Ms. Smith being treated with transcranial magnetic stimulation
27 May 2007
Phoenix Business Journal - Initiative seeking proactive approach to pain management
31 Dec 2007
NeuroInsights - Highlights of the International Neuromodulation Society World Congress
Emerging Therapies & Diagnostic Tools 
Interim Data Presented from Clinical Trial of Parkinson's Disease Patients Using New Deep Brain Stimulation System
June 18, 2013 - Six months of data from 40 Parkinson's disease patients were presented at the annual International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia concerning the Boston Scientific Vercise deep brain stimulation system, with multiple independent current control for fine, selective control of stimulation. The system is approved for sale in Europe, Israel and Australia. The interim data showed the patients from six European centers experienced approximately 60 percent mean improvement in motor function compared to baseline after six months. (Stockhouse)
Study of Deep Brain Stimulation for Alzheimer's Disease Expands
June 12, 2013 - Twenty patients with mild Alzheimer's disease have been implanted with deep brain stimulation systems in a clinical trial that was expanded from 20 to 30 patients in the U.S. along with 20 subjects approved in Canada. The trial by Functional Neuromodulation Ltd., the ADvance Study, is being supported by a $2 million grant from the U.S. National Institute on Aging. The investigation of stimulation to the fornix, a major hub in the brain's memory circuit, to slow the disease progress now includes six U.S. centers as well as the Toronto Wester Hospital. It is co-chaired by by Andres Lozano, MD, PhD, of the University of Toronto and scientific founder of the company; and Constantine Lyketsos, MD, who directs the Johns Hopkins Memory and Alzheimer's Treatment Center. (Business Wire)
Clinical Trial Initiated of Auditory Brainstem Implant in Children in the U.S.
June 11, 2013 - The Massachusetts Eye and Ear Infirmary is enrolling deaf children and infants who are not candidates for a cochlear implant in a clinical trial of an auditory brainstem implant, the Nucleus 24 ABI. The ABI stimulates auditory neurons directly at the brainstem. The device is currently FDA-approved for adults and children 12 and older who are diagnosed with neurofibromatosis type 2. The FDA issued an investigational device exemption for the current trial, which is taking place in consultation with international experts on pediatric ABI surgery, (Newswise)
Neuromodulation Appropriateness Consensus Committee Looks to the Future of Digital Drugs
June 13, 2013 - Emerging and potential future advances in neurostimulation for chronic pain are examined in recommendations of the Neuromodulation Appropriateness Consensus Committee that are being submitted for peer review to the journal Neuromodulation: Technology at the Neural Interface. The committee considered such new options as electrical stimulation to the dorsal root ganglion; new frequencies of neurostimulation; and new devices for peripheral nerve stimulation. (Newswise)
Metabolic Studies Aid Research Into Deep Brain Stimulation for Morbid Obesity
June 13, 2013 - A deep brain stimulation trial in treatment-resistant obesity linked a weight loss trend to a metabolism increase programmed in a metabolic chamber, according to a pilot study presented at the International Neuromodulation Society’s 11th World Congress by International Neuromodulation Society member Michael Oh, MD of the Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, Pa. (Newswise)
Neuromodulation Appropriateness Consensus Committee Announces Guidance on Digital Drugs for Head and Body Pain
June 12, 2013 - Six authors of Neuromodulation Appropriateness Consensus Committee guidelines are quoted today in a news release about implantable "digital drugs" for the treatment of head and body pain. The announcement was made in conjunction with the International Neuromodulation Society's 11th World Congress in Berlin. (Newswise)
June 11, 2013 - International Neuromodulation Society member Magdy Hassouna, MD, PhD, professor of surgery (urology) at the University of Toronto, presented results of a prospective study in which 23 women treated with sacral nerve stimulation for bladder disorder showed an improvement in sexual dysfunction averaging 18 percent post-treatment. (Newswise)
Study: Neurostimulation Helped Children's Intractable Constipation
June 11, 2013 - At the 11th World Congress of the International Neuromodulation Society, Bridget Southwell, PhD., of the Murdoch Childrens Research Institute of the Royal Childrens Hospital in Melbourne, Australia presented results of a novel use of transcutaneous electrical stimulation, in which home care by parents using transabdominal, noninvasive stimulation improved hardest-to-treat chronic constipation in children. (Newswise)
First Global Guidance Announced on Neurostimulation for PainJune 10, 2013 - The Neuromodulation Appropriateness Consensus Committee, an international group of more than 60 leading pain specialists led by the International Neuromodulation Society (INS) President-Elect Tim Deer, MD, announced at the INS 11th World Congress it has created the first consensus guidelines for the use of neurostimulation for chronic pain, which can significantly reduce the need for opioids. The guidance will be submitted for peer review to the journal Neuromodulation: Technology at the Neural Interface. (International Neuromodulation Society)
June 2013 - Mounting evidence for electrical stimulation therapy is fueling expanded investigation into new indications, according to a news feature in Nature Medicine that quotes International Neuromodulation Society (INS) member Kristoffer Famm, head of bioelectronics research and development at GlaxoSmithKline, which recently announced an initiative to fund up to 20 external research projects in so-called electroceuticals. The article references research presentations at the INS 11th World Congress June 8 - 13 in Berlin on clinical trials of electrical stimulation therapy in fibromyalgia and refractory angina. (Nature Medicine)
Physicians Model Cost-Effectiveness of Spinal Cord Stimulation in Chronic Pain ManagementMay 24, 2013 - Costs and effects of spinal cord stimulation (SCS) and conventional medical management alone were modeled over 20 years in a study published by International Neuromodulation Society members Krishna Kumar, MD, and Syed A. Rizvi, MD in Pain Medicine. They found the incremental cost-effectiveness ratio for SCS in failed back surgery syndrome (in Canadian dollars) was $9,293; in complex regional pain syndrome was $11,216; in peripheral arterial disease was $9,319, and in refractory angina pectoris was $9,984. (Pain Medicine)
Brain-Computer Interface Demonstrated in Noninvasive System to Control Model HelicopterJune 5, 2013 - A team at the University of Minnesota in Minneapolis demonstrated control of a model helicopter in three dimensions by an operator using a noninvasive cap of electrodes to detect changes in the strength and frequency of nerve firing in the motor cortex. The operators imagined making a fist with either or both hands to signal moving left, right, or up. Several hours of training were required in modulating sensorimotor rhythms, first with a computer cursor, then while watching the robotic vessel's progress through a camera mounted on the hull. The demonstration was reported in the Journal of Neural Engineering as a proof-of-concept for brain-computer interfaces. (Nature)
11th World Congress Presentation on Therapy for Chronic Amputation Pain PlannedJune 4, 2013 - Neuros Medical Inc. announced it will present details of its pilot study of its patented Electrical Nerve Block treatment at the upcoming International Neuromodulation Society’s 11th World Congress in Berlin, Germany, June 8-13. In the pilot study, seven out of nine patients with chronic amputation pain who received on-demand, high-frequency stimulation over the course of a year received significant pain relief, averaging 83% pain reduction. (BioPortfolio) Brain Stimulation Shows Promising Results in Vision TherapyJune 4, 2013 - Berlin-based EBS Technologies GmbH plans to expand a clinical trial of patients with neurological vision deficits after announcing that its repetitive transorbital alternate current stimulation, coupled with EEG feedback, resulted in a mean 24% increase in stimulation of the visual field compared to controls in a clinical trial of 82 patients. The treatment, approved for sale in Europe, involves 40-minute treatments over 10 consecutive days, and is designed to revitalize optical neural pathways damaged by trauma, stroke, or tumor surgery. (BusinessWire) Israeli Nonprofit Announces 10 Finalists for $1 million R&D PrizeJune 3, 2013 - International Neuromodulation Society member John Donoghue, PhD's BrainGate neural interface and nine other research competition finalists are being considered for the Israel Brain Technologies' (IBT) $1 million R&D award, B.R.A.I.N. (Breakthrough Research and Innovation in Neurotechnology). The finalists will be judged in October after presentations in Tel Aviv. IBT is a nonprofit organized to advance Israel's neurotechnology industry and increase collaboration with counterparts around the world. (Sacramento Bee)
June 1, 2013 - Researchers comparing the neuroplastic effects of brain stimulation in healthy subjects and untreated depressed subjects found that the ability to form new neural connections was stunted in the brains of depressed people. That may contribute to the lack of ability to think clearly, impacting the ability to adapt and learn, and indicates the condition is more than just a chemical imbalance in the brain. Depression treatments do increase brain plasticity. (Sydney Morning Herald)
Neuromodulation Pioneer Wins $100,000 Research Prize for Contributions to Parkinson's Disease Surgical Interventions
May 31, 2013 - For his pioneering contributions to developing strategies such as deep brain stimulation to treat Parkinson's disease, Alim Louis Benabid, MD, PhD, has received the 2013 Robert A. Pritzker Prize for Leadership in Parkinson's Research from the Michael J. Fox Foundation for Parkinson's Research. The prize comes with a $100,000 research grant. (Herald Online)
May 30, 2013 - A man who suffered from chronic pain despite repeat surgery and painkillers found relief through spinal cord stimulation, according to a newspaper account that profiles the patient, a U.S. Navy veteran. His procedure was one of the first in the Dallas-Ft. Worth area with Boston Scientific's 32-contact Precision Spectra™ system. (Star-Telegram)
Deep Brain Stimulation Field-Shaping Trial DescribedMay 29, 2013 - Sapiens Steering Brain Stimulation B.V. announced preliminary clinical trial results at the 16th international meeting of the World Society for Stereotactic and Functional Neurosurgery of its high-resolution deep brain stimulation (DBS) probe. To reduce stimulation-induced side-effects, the SureStim-1 lead shapes the stimulation field to the intended target area. In the trial, during a conventional DBS implantation surgery, the Sapiens` lead was temporarily inserted for stimulation and recording tests in eight Parkinson`s disease patients. Initial observations demonstrated the ability to steer stimulation. (Yahoo Finance) Child is First to Receive Auditory Brainstem Implant in the U.S.May 29, 2013 - In an operation at the University of North Carolina in Chapel Hill, a 3-year-old boy born without a cochlear nerve as a result of Charge syndrome became the first child to receive an auditory brainstem implant as part of a clinical trial. He will receive hearing and speech therapy to adjust to and work with his new perception of sound. (WRAL.com)
Next Challenge in Neural Interfaces May Be Developing Small, Precise ElectroceuticalsMay 28, 2013 - Getting neural interfaces to access information flowing through the nervous system and immune system is both a computing challenge and an even greater engineering challenge to see how neuroscience, disease biology and circuit design can come together, according to a news feature about GlaxoSmithKline's initiative to create small-scale, precise therapeutic interventions known as electroceuticals. The anatomical aspect of the mapping of neurons is relatively easy, but it's also important to map how electrical signals travel along them and what immune responses they provoke, the article says, referring to the immune system and the nervous system as "the two memory systems of the body". (Wired.co.uk)
Hospital Live-Tweets Deep Brain Stimulation SurgeryMay 23, 2013 - A 39-year-old actor who has had essential tremor for seven years became the 500th person at the University of California, Los Angeles Medical Center to undergo deep brain stimulation surgery. International Neuromodulation Society member Nader Pouratian, MD, performed the operation that was publicized in short videos while the patient checked his symptom improvement by playing guitar. (Huffington Post)
External Trigeminal Nerve Stimulation Study Results ReportedMay 20, 2013 - Twenty children with Attention Deficit Hyperactivity Disorder saw mean improvements of more than 45 percent after eight weeks of external trigeminal nerve stimulation in a clinical trial that was reported Monday at the American Psychiatric Association Meeting in San Francisco. (PR Newswire)
University of Oxford Research Looks at Learning Effects of Transcranial Random-Noise StimulationMay 16, 2013 - Transcranial random-noise stimulation can induce long-term enhancement of cognitive and brain functions, according to research published in Current Biology that shows students who received the stimulation while practicing math problems remained quicker than a control group at similar problems six months later. (Nature) Mood Effects of Transcranial Ultrasound Stimulation ReportedMay 16, 2013 - In a pilot study http://dx.doi.org/10.1016/j.brs.2012.05.002 of volunteers with chronic pain, researchers found that transcranial ultrasound stimulation improved mood, possibly due to "tuning" microtubules that grow and extend neurons and form and regulate synapses. The researchers who published the results in Brain Stimulation plan to study the effect in traumatic brain injury, Alzheimer's disease and post-traumatic stress disorder. (Medical Xpress) Patient Discovers Benefits of Spinal Cord Stimulation for Intractable PainMay 14, 2013 - In an interview in the Daily Express about a patient's success using a rechargeable spinal cord stimulator (SCS), International Neuromodulation Society President Simon Thomson, MD, points out that studies show SCS systems recoup their costs in 1 - 3 years due to due to a reduction in spending on drugs and repeat hospitalization. His patient found relief from SCS for her chronic back pain after relying on medications proved inadequate and risky over the long term. (Daily Express)
Neuromodulation: Technology at the Neural Interface Publishes Results of Pain Study Investigating Dorsal Root Ganglion StimulationMay 14, 2013 - International Neuromodulation Society member Liong Liem, MD, PhD, was quoted along with co-author Frank Huygen, MD, PhD about their study published yesterday in Neuromodulation: Technology at the Neural Interface regarding pain relief from neurostimulation of the dorsal root ganglion (DRG). The six-month study of 32 patients suffering from long-term nerve damage following surgery (chronic post surgical pain), complex regional pain syndrome, amputation pain, or failed back surgery syndrome showed that 70% of patients suffering from leg pain and 89% of patients suffering from foot pain reported clinically significant pain relief. The multi-center study examined the Axium spinal cord stimulation system by Spinal Modulation, which is available in Europe and Australia. (Wall Street Journal)
May 10, 2013 -- A study published in the Journal of Urology shows that most overactive bladder patients who responded to 12 weekly percutaneous tibial nerve stimulation treatments safely sustained symptom improvement over three years with an average of one treatment per month. After a 14-week treatment tapering protocol, 29 patients completed the 36-month continuing treatment. (Market Watch)
May 10, 2013 - A health column about emerging uses of deep brain stimulation (DBS) mentions Prof. Tipu Aziz of the University of Oxford, who has been investigating DBS in chronic pain. (Daily Mirror) Review: Neuromodulation Offers Potential to Manage Chronic Pelvic Pain in MenMay 10, 2013 - A review of neuromodulation (sacral nerve stimulation and percutaneous tibial nerve stimulation) in chronic pelvic pain in men (chronic prostatitis) concludes "at least a subset of patients in most of the published studies and case series derive some benefit in the short term and limited evidence suggests that long-term improvement of symptoms is possible." (Uro Today -- requires free registration)
News Report Describes Deep Brain Stimulation Surgery for Parkinsonian SyndromeMay 6, 2013 - A woman who was living with stiffness and tremors after an accident received deep bain stimulation (DBS) surgery to try to control her motor symptoms. Her neurologist plans to publish the case describing this use of DBS in Parkinsonism. (CINewsNow) Varied Response to Motor Cortex Stimulation Examined in Brain MappingMay 1, 2013 - In motor disorders such as Parkinson's disease, oscillatory activity at beta frequency is elevated, and is modulated during the generation of movements. Continuous theta burst stimulation using repetitive transcranial magnetic stimulation can inhibit motor activity for up to an hour, but the neuroplastic effects are highly variable between individuals. Brain mapping of 16 healthy research subjects with magnetoencephalography suggests the observed variability may relate to GABAergic mechanisms that govern the presence of oscillatory beta activity in the motor system. (Journal of Neuroscience) Study Shows Subthalamic Nuceus Stimulation Impacts Metabolic StateApril 30, 2013 - A study of a nonmotor impact of deep brain stimulation to the subthalamic nucleus in patients with Parkinson's disease showed on-stimulation decreases endogenous glucose production by 22% compared to off-stimulation or controls, without altering whole body glucose disposal, suggesting that cross-talk between the central nervous system and peripheral tissues may regulate glucose homeostasis. (Journal of Clinical Endocrinology & Metabolism)
Tennessee Pain Practice Begins Offering 32-Contact Spinal Cord Stimulation Systems
May 1, 2013 - International Neuromodulation Society member William Newton, DO, became the first physician in his state to implant a next-generation, 32-contact spinal cord stimulation (SCS) system for chronic pain of the trunk and/or limbs, according to a news report. He commented that many patients cycle through various therapies before trying SCS since it can be hard to treat, so encourages people living with chronic spine pain to talk to their physician and see if the treatment might be appropriate for them. (WGNS)
April 23, 2013 - Mice receiving deep brain stimulation to the nucleus accumbens consumed less high-fat food compared to controls according to a paper published in the Journal of Neuroscience. At the same time, similar stimulation to obese mice resulted in less calorie consumption, a loss of body weight, and improved glucose sensitivity -- suggestive of a reversal of type 2 diabetes. (University of Pennsylvania)
Deep Brain Stimulation Investigator Describes Therapeutic Opportunity to Tune Brain Circuits April 23, 2013 - During a visit to Houston, pioneering neurologist Dr. Helen Mayberg discussed deep brain stimulation, saying the brain "works as ensembles, like an orchestra, with coordinated interactions among different areas for different functions. Identifying circuits and using electricity to tune them - the brain uses electricity to communicate - is attractive because while it's brain surgery, tuning the brain is not permanent; it's reversible. You can try a setting, and if it doesn't work, you can turn it off. You can remove the electrodes and it doesn't generally damage the brain." (Houston Chronicle)
April 2013 - Researchers specializing in spinal cord stimulation (SCS) reviewed records of 16,455 spine surgery patients who had continued chronic pain -- so-called Failed Back Surgery Syndrome -- and found only 2.4% of those underwent SCS implantation from 2000 - 2099, according to a study presented at the 2012 annual meeting of the North American Neuromodulation Society. Surgeons should be more aware that SCS may be superior to repeat surgery in select patients, said study co-author Nandan Lad, MD, PhD, a member of the International Neuromodulation Society and assistant professor of neurosurgery, Duke University School of Medicine. (Anesthesiology News) Small U.S. Study of Repetitive Transcranial Magnetic Stimulation Finds Little Benefit in TinnitusApril 22 - A U.S. study published in JAMA Otolaryngology - Head & Neck Surgery of 14 patients with tinnitus showed that four weeks of sessions of repetitive transcranial magnetic stimulation improved their chronic ringing in the ears by 10 points, while crossover sham treatment yielded a six-point improvement. (Reuters)
Study: Spinal Cord Stimulation to the Cervical Spine Relieved Pain for Majority of PatientsApril 2013 - An observational study, presented by International Neuromodulation Society President-Elect Dr. Tim Deer at the 2012 annual meeting of the North American Neuromodulation Society, supports the use of spinal cord stimulation in the cervical spine for chronic pain. The study, part of an ongoing 40-center registry study supported by a research grant from St. Jude Medical, tracked 38 patients for at least three months and found that most reported their pain relief as being excellent or good. (Pain Medicine) Authors Present Benefits of Early Neurostimulation in Parkinson's DiseaseApril 16, 2013 - Drs. Suneil K. Kalia and Andres M. Lozano of Western Hospital in Toronto have published an opinion article describing benefits of early neurostimulation in Parkinson's disease. (Nature Reviews Neurology)
Cigarette Craving Temporarily Reduced in Transcranial Magnetic Stimulation StudyApril 16, 2013 - A dose of transcranial magnetic stimulation was shown to temporarily reduce nicotine craving in in smokers in a sham-controlled trial by a team at the Medical University of South Carolina, published in Biological Psychiatry. The stimulation focused on the dorsolateral prefrontal cortex, a region linked with cue-related behavior, such as the sight of a cigarette triggering a craving. (Wired.co.uk) Florida Analysis Shows Sacral Neuromodulation Procedures are Increasing Although Regional Rates VaryApril 16, 2013 - Analyzing ambulatory surgery data from 2002 - 2009 in Florida shows that rates of sacral nerve stimulation increased significantly, but rates were variable by region, according to a report by members of the departments of Urology and Obstetrics and Gynecology at the University of Michigan. The most common indication was overactive bladder. The authors speculate the range in practice patterns may reflect medical uncertainty about the role of the procedure. (Surgical Innovation) Two-Year Follow-up Shows Patients With Neurogenic Diagnoses Still Benefited from Sacral NeuromodulationApril 15, 2013 - Looking at outcomes of sacral neuromodulation in 332 patients, 71 of whom had a co-morbid neurologic disorder, follow-up over two years showed that patients with neurogenic bladder dysfunction experienced benefits after neuromodulation similar to the benefits experienced by those without coexisting neurologic conditions, according to a study in Urology. (Urology)
Physicians in Colombia Receive Spinal Cord Stimulation TrainingApril 15, 2013 - An interview with a chronic pain patient mentions that International Neuromodulation Society member Carlos Viesca, M.D. recently returned from providing spinal cord stimulation training to 200 anesthesiologists and neurosurgeons in three cities in Colombia. (El Paso Times) Study Examines Role of Deep Brain Stimulation in Gait and Multi-TaskingApril 15, 2013 - Since the ability to walk while dual-tasking has been related to fall risk, researchers examined attention, executive function, and gait in 28 patients with advanced Parkinson's disease with bilateral sub-thalamic nucleus deep brain stimulation on and off, both with and without medication. The stimulation improved motor symptoms, certain features of gait and attention, but not executive function. However, stimulation apparently failed to reduce the negative impact of a dual task on walking abilities. (Journal of Neuroengineering and Rehabilitation)
Case Series Presents Anchoring Option for Spinal Cord Stimulation Leads or PaddlesApril 11, 2013 - At the 29th Annual Meeting of the American Academy of Pain Medicine, a case series of three patients was presented in which multiple lead arrays and paddle leads were placed through a percutaneous port and anchored using dissection along the spinous process and placement of a perforating towel clamp, deep in the paraspinal musculature. The clamps created an anchoring point for the leads. Each patient was followed for at least one year. (Medical Xpress) PET Scanning and Optogenetics Highlight Role of Neural Networks in Response to Targeted StimulationApril 11, 2013 - Researchers at the U.S. Department of Energy's Brookhaven National Laboratory published an online paper in the Journal of Neuroscience that describes combining optogenetic stimulation and PET scans to trace effects of localized stimulation throughout the brain of laboratory rats. The method helps show which downstream neurological pathways are activated or inhibited by stimulation, and how that correlates with behaviors and/or disease conditions. The work could provide fine-scale control such as comparing the role of dopamine D1 or D2 receptors involved in processing reward, and might help refine treating conditions ranging from depression to Parkinson's disease, neurodegenerative disorders and drug addiction, as well as provide treatment monitoring. (Medical Xpress) Healthcare Industry Observer Sees Potential Promise in Investigative Treatment for DepressionApril 11, 2013 - The director of chemical and pharmaceutical sciences at the American Council on Science and Health, Josh Bloom, Ph.D., calls promising early reports about investigations of deep brain stimulation for treatment-resistant depression "potentially huge" and able to "help reinforce the idea that depression is a physical disease of the brain." (American Council on Science and Health)
Deep Brain Stimulation for Parkinson's Disease is Called Cost-Effective for the German Healthcare SystemApril 10, 2013 - In a study supported by the German Ministry of Education and Research, a team of journal co-authors from institutions in Austria and Germany, as well as Harvard Medical School, provide a lifetime statistical analysis of deep brain stimulation (DBS) for Parkinson's disease that supports adopting and reimbursing DBS within the German health care system. They conclude DBS can be considered cost-effective, offering a value-for-money profile comparable to other well-accepted health care technologies. The lifetime incremental cost-utility ratio for deep brain stimulation was €6700 per quality-adjusted life year (QALY) and €9800 and €2500 per United Parkinson's Disease Rating Scale part II (motor experiences of daily living) and part III (motor examination) score point gained, respectively. Deep brain stimulation costs were mainly driven by the cost of surgery and of battery exchange. (Movement Disorders) Bonn Researchers Report a Positive Pilot Study with New Stimulation Target for Major Depressive DisorderApril 10, 2013 - Professors at Bonn University Hospital report on seeing improvements within days in major depression symptoms in six of seven patients treated with bilateral deep brain stimulation to a relatively novel target, the supero-lateral branch of the medial forebrain bundle, a structure that runs from the limbic system to the prefrontal cortex. They report that a high proportion of responders needed lower stimulation intensities than seen in previous studies. Their pilot study appeared in Biological Psychiatry online April 5. (Gizmag)
Repetitive Transcranial Magnetic Stimulation Shows Effect in Focal DystroniaApril 9, 2013 - In a study in Restorative Neurology and Neuroscience of 17 people with focal hand dystonia, 68% reported that their symptoms improved after 5 daily sessions of low-frequency repetitive transcranial magnetic stimulation and 58% said their symptoms were better 10 days post-treatment. The stimulation was given while patients performed writing movements that did not trigger their dystonic symptoms. Although handwriting was not improved at a 10-day follow up, three patients contacted the investigators for additional treatment, indicating that they felt their symptoms had improved for several months. (Medical Xpress) Vagus Nerve Stimulation Research into Appetite Control Receives SupportApril 9, 2013 - Researchers at Imperial College London have received $9 million from the European Research Council to support development of a potential treatment option for obesity. The researchers' investigative device uses a nerve cuff electrode to target the branch of the vagus that ennervates the gut. The controller is intended to read conditions in the stomach and provide signals of satiety to the brain with proper stimulation. (Medical Xpress)
Modeling Shows Major Effect of Slight Changes in Location of Deep Brain Stimulation April 6, 2013 - In a patient receiving deep brain stimulation of the subcallosal cingulate white matter -- as an investigative treatment for major depressive disorder -- a model of pathways that may mediate the effect predicts stimulation effects, and suggests, based on different simulated activation patterns from four different electoral contacts, that small differences in location can generate substantial differences in the directly activated pathways. The new tool, a tractography-activation model (TAM), combines imaging data, electric field modeling of stimulation parameters, and activation pathway prediction. In part, the TAM predictions are suggested by cable models of different axon states. (Brain Stimulation) Researchers Raise Considerations Regarding Motor Cortex Stimulation for Stroke RehabilitationApril 4, 2013 - Researchers in New Zealand and Australia report on a model of stroke rehabilitation in which the importance of control exerted by the motor cortex on the opposite side of the body suggests that careful consideration be given to using noninvasive brain stimulation to suppress the motor cortex there. They conclude that neurophysiological, neuroimaging, and clinical assessments can facilitate the best use of noninvasive brain stimulation in a stroke rehabilitation setting. (Frontiers in Neuroscience) Study: Deep Brain Stimulation Should Be Offered to Early Stage Parkinson's Disease Patients -- with Some CaveatsApril 4, 2013 - A brief article about the EARLYSTIM trial, reported in the Feb. 14 issue of the New England Journal of Medicine, notes that the randomized trial of 251 patients who were followed over two years in European centers shows an overall benefit in the group that received neurostimulation rather than medical treatment alone, although there were more frequent adverse events in the group that received deep brain stimulation. For instance, major depression occurred more often, although there was an overall improvement in mood by the end of the trial. (Neurology Today)
April 5, 2013 - A local television station reports about a man whose Parkinson's disease improved after he received a deep brain stimulation system. Three years after the implant, he is helping to raise awareness in support of fundraising events of the Southwest Louisiana and Southeast Texas chapter of the National Parkinson Foundation. (KPLC) Mississippi Site Starts Enrolling Back Pain Patients in Clinical TrialApril 5, 2013 - PROMISE is a prospective randomized clinical trial to compare the outcomes of using optimal medical management for predominant low back pain alone, or with multicolumn implantable lead stimulation. The multi center trial is now enrolling patients at the Singing River Health System Neuroscience Center, one of up to 30 centers in the U.S., Canada and Europe participating in the Medtronic, Inc.-sponsored study. The study seeks participants who have persistent or recurring pain in the back and/or legs following one or more spine surgeries. (Mississippi Press)
April 4, 2013 - The prelimbic region of the prefrontal cortex plays a central role in compulsive cocaine addiction, according to preclinical optogenetics research in the journal Nature. Researchers at the National Institute on Drug Abuse, the Ernest Gallo Clinic and Research Center and the Johns Hopkins School of Medicine introduced light-sensitive proteins in rat neural cells in that brain region, and introduced light there through fiber optics to increase or inhibit neural activity. Activating the neurons eliminated the compulsive behavior displayed by some of the rats in the study, and inhibiting neural activity in that region triggered compulsive cocaine-seeking behavior in the non-addicted rats. (UCSF)
U.S. BRAIN Initiative Would Create a Dynamic Map of Brain ActivityApril 2, 2013 - U.S. President Barrack Obama unveiled a proposed $100 million initiative, Brain Research through Advancing Innovative Neurotechnologies (BRAIN), that is intended to show how individual cells and complex neural circuits interact in both time and space. The National Institutes of Health (NIH) is establishing a high-level working group to help articulate scientific goals and develop a multi-year plan with timetables, milestones, and cost estimates. Input will be sought from the scientific community, patient advocates, and general public. By fall 2013 the working group should have specific recommendations on investments for fiscal year 2014, with a final report due to the NIH director in June 2014. NIH is working closely with other government agencies, including the Defense Advanced Research Projects Agency and the National Science Foundation. Private foundations have expressed interest and support, including the Howard Hughes Medical Institute, the Allen Institute for Brain Science, The Kavli Foundation, and the Salk Institute for Biological Studies. Private industries are also interested in becoming involved. The NIH enterprise-wide Blueprint for Neuroscience Research will lead planning contributions, and published an NIH toolbox for such assessments as pain, cognition, and movement disorder in the March 12, 2013 issue of Neurology. (NIH)
Grant Supports Early Stage Research in Deeply Targeting Transcranial Magnetic StimulationApril 1, 2013 - The Roy J. Carver Charitable Trust is giving $395,280 to Iowa State University to support research into directing transcranial magnetic stimulation into deep brain areas as a potential non-invasive treatment of such disorders as Parkinson's disease. Engineering and veterinary faculty are teaming to carry out the research in mice. (Iowa State University) Transcranial Direct Current Stimulation Bears Careful Consideration, Magazine Writer ConcludesApril 1, 2013 - A balanced approach seems best in researching the pros and cons of potentially using technology -- such as transcranial direct current stimulation (tDCS) -- to enhance human performance, a writer concludes after conducting a number of interviews over the course of a two-month series about various potential types of human enhancement. Besides its being explored to treat severe depression or aid rehabilitation from stroke, the article notes, there has been research interest in the potential of tDCS to enhance learning of cognitive tasks or performance in training exercises. (Slate)
Vagus Nerve Stimulation System for Weight Control Would Include a Smart SensorApril 1, 2013 - Researchers at Imperial College London are developing a "smart" microchip to modulate sensations of appetite through sensing and stimulation at the vagus nerve. Earlier, the team developed a similar device that targets the vagus nerve to reduce epileptic seizures. Existing devices that target the vagus nerve to reduce food consumption are EnteroMedics' VBloc device and the Abiliti device by IntraPace. The latest device may be ready for human trials within three years. (Inland News Today) Deep Brain Stimulation Capability Comes to Abu DhabiMarch 31, 2013 - Abu Dhabi now has a deep brain stimulation (DBS) service at Sheikh Khalifa Medical City. The new service is unfamiliar to insurance companies, says Maher Mansour, MD, a consultant neurosurgeon at the facility. However, nationals of Abu Dhabi do receive partial coverage from the national medical coverage program. In a related article, the mother of a patient who acquired dystonia following a brain injury expressed gratitude for access to DBS surgery there. (The National) Spinal Cord Stimulation Featured in Business Column March 29, 2013 - International Neuromodulation Society member Anthony Berg, MD, was interviewed by a business columnist about using the new 32-contact Precision Spectra spinal cord stimulator by Boston Scientific. In the three cases he has implanted so far, patients have all seen a significant drop in use of pain medication and an improvement in quality of life, he said. (Dallas Business Journal)
March 28, 2013 - A neurosurgical navigation platform that permits deep brain stimulation surgery under general anesthesia, the ClearPoint® Neuro Intervention System by MRI Interventions, Inc. was featured on the Fox News Health website about MRI-guided brain surgery being easier on Parkinson's patients. (Daily Markets) Two Alzheimer's Patients Have Received Deep Brain Stimulation Systems as Part of StudyMarch 28, 2013 - Two women have been implanted with deep brain stimulation systems as part of a 10-person study at The Ohio State University to explore whether the stimulation has protective effects in the progression of Alzheimer's disease. The first patient has completed 12 weeks of stimulation. The study will examine the impact of stimulation over time on thinking, focus and alertness. (HealthDay)
March 23, 2013 - A team of researchers at INSERM and the Centre Hospitalier Universitaire in Rennes, France report on their model of a brain network that includes the biophysical effects of direct stimulation, based on EEG data from a patient with drug-resistant epilepsy and a focal cortical dysplasia. The dysplasia responds to either high- or low-frequency deep brain stimulation, but not intermediate-frequency. In the model, it appeared the frequency-dependent response could be explained by: a) feed-forward inhibition and synaptic short-term depression of thalamocortical connections at low-frequency stimulation, and b) inhibition of the thalamic output at high-frequency stimulation. (Frontiers in Computational Neuroscience)
FDA Clears Trial of Vagus Nerve Stimulation in Heart FailureMarch 26, 2013 - The FDA has approved BioControl Medical's third and largest phase of the clinical trial of its vagus nerve stimulator CardioFit® in heart failure. INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) is a global, multi-center, investigational device exemption (IDE) clinical study of the company’s CardioFit® system for heart failure. The approval, which is based on the FDA’s safety review of the first two successful completed phases, allows unconditional study expansion to full enrollment of 650 patients at 80 centers worldwide. (Business Wire) Case Series Indicates Relative Effectiveness of Retrograde Spinal Cord Stimulation in Failed Back Surgery Syndrome and Perineal PainMarch 2013 - Retrograde neuromodulation -- spinal cord stimulation directed toward the sacrum -- appeared effective in patients who had a well-localized pain and clear dermatome distribution, according to a series of 10 patients at the University General Hospital of Valencia in Spain, in which seven of 10 patients had effective stimulation. Retrograde neuromodulation appeared most effective in radiculopathy related to failed back surgery syndrome, and of limited effectiveness in treating perineal pain. (Pain Physician)
Start-up to Present Results of External Trigeminal Nerve Stimulation in Refractory Epilepsy
March 25, 2013 - Los Angeles-based NeuroSigma, Inc. will report on the first example of potential clinical utility of its external trigeminal nerve stimulation device, the Monarch™ eTNS™ System, as an adjunctive treatment in refractory status epilepticus at the 4th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures to be held in Salzburg, Austria from April 4-6, 2013. (PR Newswire)
Lecture to Examine Past, Present and Future of Deep Brain Stimulation
March 18, 2013 - Neuromodulation: Technology at the Neural Interface editorial board member Kim Burchiel, MD, planned to present the past, present and future of deep brain stimulation during a lecture series at the Oregon Health & Science University. In an introductory blog post, he concluded, "the technology poses the bioethical question of whether our ability to modify brain function should be uncritically applied." (Oregon Health & Science University - On the Brain)
Device Company Supplier Works on Spinal Cord Stimulation Prototype
March 23, 2013 - Greatbatch Inc.'s ambitious, five-year, $50-million initiative to develop medical devices -- starting with a spinal cord stimulation (SCS) system, Algostim -- may capture a significant share of the $1.4 billion SCS market, according to a news feature in the Buffalo News. The company is growing its intellectual property portfolio, and will retain is business supplying components to makers of neurostimulation and cardiac rhythm management devices. For Algostim, it would design and manufacture the devices but use a marketing partner for commercialization. (Buffalo News)
Startup Targets Bladder Control with Spinoff Nerve Stimulation Device
March 22 - The Atlanta-based startup ConservoCare LLC is developing a high-frequency electrical nerve stimulation system for urinary retention or incontinence. The device is designed to eliminate spasms of the urethral sphincter and allow the bladder to function. Using technology licensed from Case Western Reserve University, the company has been financed by a $125K Phase I Small Business Technology Transfer grant from the National Institutes of Health, and by Case’s Translational Research Partnership with the Wallace H. Coulter Foundation. (MedCity News)
Optogenetics' Therapeutic Promise Discussed
March 20, 2013 - Perspectives articles in Science Translational Medicine address requirements for turning the technology of optogenetics into a therapy, and describe potential new circuit-level targets or biochemical, cellular events for intervention. (Science Translational Medicine)
Show Highlights Use of Deep Brain Stimulation for Parkinson's Disease
March 15, 2013 - In a television segment, deep brain stimulation (DBS) for Parkinson's disease is called a little-known procedure that hasn't been reaching all the patients and physicians who could benefit. The segment includes an example of a patient whose tremor and medication dosages were reduced after she received DBS. (Windycitylive.com)
Australian Radio Show Reports on a Deep Brain Stimulation Operation
March 14, 2013 - In a radio interview with two neurosurgeons, a radio segment describes being in the operating theater during a deep brain stimulation surgery and inquires about the future for better understanding and treating disorders of neural circuits. (612 ABC Brisbane)
Acute Migraine Treatment Study Using External Vagus Nerve Stimulation to Be Presented at Meeting
March 13, 2013 - ElectroCore®, announced that its study of patients with acute migraine headache treated with its non-invasive, portable vagal nerve stimulation treatment, GammaCore®, will be presented at the American Academy of Neurology Annual Meeting March 16-23 in San Diego. In the study, 27 participants treated an acute migraine with two, 90-second stimulation doses, applied externally at 15-minute intervals and delivered to the right cervical branch of the vagus nerve. Two-thirds of patients treated at mild pain were pain-free at two hours. Treatment-related adverse effects were limited. The company is now enrolling patients in a chronic migraine prevention study at several U.S. centers.
Repetitive Transcranial Magnetic Stimulation Aided Working Memory Issues for Schizophrenia Patients in Pilot Study
March 12, 2013 - Researchers at the University of Toronto have used repetitive transcranial magnetic stimulation (rTMS) to improve working memory in 27 medicated schizophrenia patients in a double-blind pilot study. After 20 rTMS sessions over four weeks, the improvement was comparable to healthy subjects. Working memory problems can be a functionally disabling component of schizophrenia. (Science Daily)
New Content Posted to INS Website on Spasticity and Rehabilitation Approaches
March 10, 2013 - International Neuromodulation Society member Konstantina Petropoulou MD, PhD, of the National Rehabilitation Center in Athens, Greece, has written an overview for healthcare professionals regarding management of spasticity with a focus on rehabilitation, including the use of intrathecal drug delivery systems. She has also contributed review of a brief description of the condition for non-specialists, posted to the INS website, at http://www.neuromodulation.com/spasticity.
Laboratory Research: Stimulation of Brainstem May Speed CNS Injury Recovery
March 10, 2013 - Preclinical research indicates that applying electrical stimulation to the rap he nuclei of the brainstem may induce biological control mechanisms that could enhance recovery from traumatic brain injury or spinal cord injury. (Neurotech Zone)
U.S. Army is Collaborating on Neurostimulation Device Worn on the Tongue During Rehabilitation Activities
March 7, 2013 - Researchers at the U.S. Army Medical Research and Materiel Command, in collaboration with the University of Wisconsin-Madison and NeuroHabilitation Corporation, are working on a battery-operated neurostimulator that is inserted on the tongue for periods of 20 minutes or so during rehabilitation activities. Called the Portable NeuroModulation Stimulator (PoNs), it is designed to provide so-called "cranial nerve non-invasive neuromodulation" to the brainstem. PoNs has been considered for helping improve balance in patients who have multiple sclerosis, or assisting treatment of people suffering from concussion or brain injury. Testing will include a collaborative study with researchers and clinicians at the Blanchfield Army Community Hospital in Fort Campbell, Ky.
Brain Stimulation in Anorexia Trial Shows Effects Beyond Stimulation Target
March 7, 2013 - A news feature describes a woman who had anorexia nervosa for two decades and has achieved a healthy weight as part of a clinical trial led by Dr. Andres Lozano of Toronto Western Hospital. He said the targeted area of the brain, the subcallosal cingulate, is turned down by the stimulation, likely toning down the anxiety, depression and other moods disorders that are hallmarks of the eating disorder. A surprise was an area of the brain involved with self-perception, or body image, was turned up. He compared the stimulation to a butterfly flapping its wings, since changing the activity of one area of the brain has consequences at other areas that are remote but are connected. (The Canadian Press)
Researchers Report Results From Early Trial of Deep Brain Stimulation in Anorexia Nervosa
March 6, 2013 - In a Phase I safety trial of six patients with treatment-resistant anorexia nervosa, by nine months after the start of deep brain stimulation to the subcallosal cingulate, half the patients had gained weight, four had improved mood, and two of those completed an inpatient eating disorders program, according to a research report in The Lancet. (Medical Xpress)
Television Segment Features Young Parkinson's Disease Patient's Neurosurgery
March 6, 2013 - Nine years after being diagnosed with Parkinson's disease at age 29, an Arizona man became one of about 1,000 patients so far to undergo a new deep brain stimulation surgery that takes place while the patient is under anesthesia. (ABC News)
Brain Stimulation for Learning Study Shows Tradeoffs in Speed and Concentration
March 5, 2013 - A controlled research study on 19 healthy volunteers at the University of Oxford found that transcranial electrical stimulation during a mathematical training exercise had mixed effects. Subjects whose parietal area was stimulated performed more quickly during the weeklong study, but they were slower to put their new learning to use on a novel task. Meanwhile, volunteers who had the prefrontal area stimulated were slower than controls in learning the new numerical system but quicker to apply it to a new test at the end of the experiment. (Wired)
Deep Brain Stimulation Service in Vancouver Experiences Growing Demand
March 6, 2013 - The province of British Columbia has only one neurosurgeon performing deep brain stimulation surgery at up to about 40 cases annually -- resulting in a waiting list of almost three years. The service is budgeted as a local program of the Vancouver Coastal Authority although most patients live outside that region. So far efforts to find research funding from a charitable group focused on Parkinson's disease have been unsuccessful. (Vancouver Sun)
Temporary Electrodes Track Excessive Brain Synchronization in Motor Disorder and Therapeutic Effect of Deep Brain Stimulation
March 4, 2013 - A method to detect excessive brain synchronization at the surface of the brain in people with Parkinson’s disease is being reported online this week in the Proceedings of the National Academy of Sciences, based on three years of study by researchers at the University of California, San Francisco; University of Cincinnati; Stanford University; and the University of Washington Medical Center. The researchers used flexible electrodes at the surface of the brain to detect activity there during neurosurgery. The study was conducted in 25 patients -- 16 with Parkinson’s disease and nine with cervical dystonia. The researchers compared the the brain activity of these patients who had motor disorder to that recorded in patients who were being operated on for epilepsy. The research showed the effect of deep brain stimulation in halting excessive synchronization. Such findings could contribute to future neurostimulation approaches that respond automatically and flexibly to a patient’s needs. (University of California, San Francisco)
Access to Epilepsy Treatment Affected by Limited Information
March 4, 2013 - Despite the existence of interventions for epilepsy that include 26 approved medications in the U.S. and FDA-approved vagus nerve stimulation, access to care and referrals to treatment still fall short, according to a neurologist who contributed to a 2012 Institute of Medicine panel on the issue. Dr. Joseph Sirven, professor of neurology and department chair at the Mayo Clinic Arizona, writes that misinformation and lack of information are one limiting factor. (NBC Latino)
Small Study of Focused Transcranial Direct Current Stimulation Lowered Pain Perception in Fibromyalgia
Feb. 28, 2013 - A novel noninvasive brain stimulation technique, high-definition transcranial direct current stimulation (HD-tDCS), which uses algorithms to focus and target stimulation, was tested in single, 20-minute sessions on 18 patients who have fibromyalgia in a sham-controlled crossover trial. The stimulation was reported in the Journal of Pain to provide significant reduction in overall perceived pain as compared to sham stimulation, regardless of polarity. (ProHealth.com)
Thought-Controlled Prosthetic Arm Implanted
Feb. 26, 2013 - An amputee in Sweden has received the first permanent implantation of a prosthetic arm that is attached to the bone via a titanium socket, and controlled by electrodes implanted in his nerves and muscles. Designed at Chalmers University with contributions from Sahlgrenska University Hospital, the limb is designed to permit more movements than a simple, externally attached, robotic hand. (Gizmag.com)
Early Deep Brain Stimulation in Youths With Dystonia Showed Lingering Benefit
Feb. 22, 2013 - Two patients whose primary generalized dystonia was successfully treated in their teens with bilateral pallidal deep brain stimulation (DBS) were reported to retain clinical benefit for at least two months after their devices had inadvertently been switched off. Unusually, the reappearing symptoms were milder than before. It is hypothesized the stimulation induced changes in the abnormal neural connectivity underlying the disease -- possibly due to their young age, short duration of disease and length of time on DBS, as well as their relatively low level of stimulation. Details and commentary were published in Movement Disorders (Medscape Medical News)
External Trigeminal Nerve Stimulation Study Author Notes Effects on Seizures, Mood
Feb. 21, 2013 - Both anti-epileptic effect and mood effects appeared in a double-blind, randomized, active-control trial of external trigeminal nerve stimulation that was completed by 42 patients who have medically resistant epilepsy. An interview with lead study author Christopher M. DeGiorgio, MD, professor of neurology at the University of California, Los Angeles, and vice president of NeuroSigma, appeared in Neurology Today, along with a podcast interview. He said response climbed to 40.5 percent of the treatment group by 18 weeks. (Neurology Today)
High-Frequency Stimulation Shown to Yield Chronic Back Pain and Leg Pain Relief
Feb. 26, 2013 - International Neuromodulation Society members Jean-Pierre Van Buyten, MD, Adnan Al-Kaisy, MD and colleagues report in Neuromodulation results of a trial of high-frequency spinal cord stimulation without parathesia using the Nevro Corp. Senza system. The trial enrolled 83 patients with chronic back pain. Of 72 patients who went on to permanent implant, more than 70% had significant and sustained low back pain and leg pain relief. (NeuroNews)
Using 32 Contacts Allows Neurostimulation to Circle Skull for Chronic Headache "Halo" Treatment
Feb. 25, 2013 - International Neuromodulation Society member Nameer Haider, MD, announced a neurostimulation treatment for chronic headache that circles the skull. The 360-degree Halo procedure uses 32 electrical contacts to stimulate 12 nerves; supraorbital/supratrochlear, auriculotemporal, and greater/lesser occipital. (PR Web)
Therapeutic Effect of Stimulation on Neural Circuit Revealed in Brain-Imaging Study
Feb. 25, 2013 - An fMRI study in patients who received deep brain stimulation for obsessive compulsive disorder showed the communication between the nucleus accumbens, which influences motivation, and the frontal cortex, which aids decision-making, was increased when stimulation was off, and was higher than in healthy participants. That excessive connectivity is what deep-brain stimulation seems to break, said investigator Martijn Figee, MD, of the Academic Medical Center in Amsterdam. Stimulation appears to override disease-linked oscillations between the two regions. (Technology Review)
Advisory Panel Supports FDA Approval of Closed-Loop Neurostimulator for Epilepsy
Feb. 24, 2013 - An FDA advisory panel voted on Friday 11-0, with two abstentions, to recommend approval of NeuroPace Inc.'s RNS System, a closed-loop neurostimulator that is placed just under the skull to control epilepsy. (Newsday)
Study: Effect of Deep Brain Stimulation on Obsessive Complusive Disorder
Feb. 24, 2013 - International Neuromodulation Society member Brian Snyder, MD, described obsessive compulsive disorder (OCD) as a "disorder of neurocircuitry" in an article describing a Dutch study of deep brain stimulation to a part of the brain that is involved in motivation and reward processing, the nucleus accumbens. Published in Nature Neuroscience, the study showed that stimulation essentially restored normal functioning to that part of the brain in 16 patients with OCD. (Medical Xpress)
Patients Sought for Ongoing Trial of Spinal Cord Stimulation in Refractory Angina
Feb. 22, 2013 - Additional patients are being recruited for a feasibility trial of spinal cord stimulation (SCS) in patients with refractory angina. The RASCAL (Refractory Angina Spinal Cord stimulation and usuAL care) pilot study compares SCS to usual care alone. The U.K.-based investigators include International Neuromodulation Society members Sam Eldabe, MB ChB, FFPMRCA; Jon Raphael, MB ChB MSc MD FRCA; Simon Thomson, MBBS, FRCA, FIPP; Brookes Morag, RGN, BSc; and Rod S. Taylor, PhD. (7th Space)
Closed-Loop Neurostimulation for Epilepsy To Be Reviewed by FDA Panel
Feb. 21, 2013 - An FDA advisory panel is scheduled to vote today on whether to recommend approval of the first neurostimulation device that operates in a responsive, closed-loop fashion through detecting possible seizure onset in epileptic patients and delivering stimulation when apparently needed. The RNS System by Mt. View, Calif.-based NeuroPace, Inc. will be presented today to the panel, along with comments from the public, including representatives of the Epilepsy Foundation highlighting the need for innovative treatments. (Medical Xpress)
Vagus Nerve Stimulation Trial in Heart Failure Comes to Mississippi
Feb. 21, 2013 - North Mississippi Medical Center implanted the first vagus nerve stimulation system in the state as part of a clinical trial to treat heart failure. The CardioFit device by BioControl Medical is undergoing a worldwide investigation through the Innovate-HF trial. Two patients were implanted in the fall at the Tupelo, Miss.-based medical center, and commented in an article by the center that they have noticed a difference since then in their quality of life or activity levels. (Marketwire)
International Neuromodulation Society Member is a Key Figure in Proposed U.S. Brain Activity Map (BAM) Project
Feb. 19, 2013 - International Neuromodulation Society member John Donoghue, professor of neuroscience at Brown University, is described as "one of the core scientists" involved in the proposal for U.S. agencies to create brain-activity-mapping scientific observatories to produce open-source data, similar to the Human Genome Project, over the next decade. He was quoted as saying the effort should unite neuroscientists working in the field and attract engineers and computational scientists to find ways to better understand the function of neural networks and their role in brain disorders and treatment. (Time)
Researcher Describes Plans to Implant Prosthetic Hand Controlled by Thought
Feb. 17, 2013 - Later this year, a man in his 20s in Rome will be fitted with a neuroprosthetic hand integrated with sensors linked to his nerves. He lost the lower part of his arm after an accident. The prosthetic is designed to provide sensory information from the fingertips, palm and wrists. It is intended to be attached to his arm's ulnar and median nerve branches to permit control of the hand's movement and provide sensory input, according to a talk by Silvestro Micera of the Ecole Polytechnique Federale de Lausanne in Switzerland at the American Association for the Advancement of Science meeting in Boston. (Independent)
Patient Describes His Experience with Deep Brain Stimulation Therapy for Essential Tremor
Feb. 15, 2013 - In an account that mentions International Neuromodulation Society member Ashwini Sharan, MD, a patient with essential tremor describes his decision to receive deep brain stimulation therapy after learning about it on television. (Jefferson University Hospitals)
Artificial Retina Implant Receives First U.S. Humanitarian Device Approval
Feb. 14, 2013 - The U.S. FDA announced it has approved the first implantable device to treat advanced retinitis pigmentosa (RP) in adult patients, the Argus II Retinal Prosthesis System by Second Sight Medical Products, Inc. is based in Sylmar, Calif. The device uses a small video camera and transmitter mounted on eyeglasses and an artificial retina to improve the ability to detect light and dark. RP is a rare genetic disorder affecting about 100,000 patients in the U.S. Multimedia coverage of the Humanitarian Device approval appeared in the Wall Street Journal (FDA)
Steering Repetitive Transcranial Magnetic Stimulation to Deep Brain May Relieve Pain
Feb. 15, 2013 - In work presented at the 2012 annual meeting of the Society for Neuroscience, Stanford University researchers demonstrated in healthy subjects and fibromyalgia patients that transcranial magnetic field pulses directed to the anterior cingulate cortex may be effective in reducing acute or chronic pain. The researchers used four magnets and mathematically directed steering. (Scientific American Mind)
Neurologist Recounts Path of Development of Potential Deep Brain Stimulation Treatment of Alzheimer's Disease
Feb. 15, 2013 - Neurologist and author Richard C. Senelick, MD, writes in a column about the slow but potentially promising application of deep brain stimulation (DBS) to delay the effects of Alzheimer's disease. He notes the use of DBS for essential tremor and Parkinson's disease has become routine in the United States and Europe, improving the lives of over 100,000 people. In addition, new studies explore the use of DBS for depression, obsessive-compulsive disorder, obesity, and chronic pain. While studying the use of DBS in obesity, researchers observed that it produced increased memory. This led to safety trials and then clinical trials as a potential Alzheimer's disease therapy. (The Atlantic)
Study: Early Deep Brain Stimulation in Parkinson's Disease Shows Benefits
Feb. 14, 2013 - In a two-year study http://clinicaltrials.gov/show/NCT00354133, researchers from Germany and France conclude that subthalmic stimulation was superior to medical therapy in patients with Parkinson's disease and early motor complications. In the study, 251 patients were randomly assigned to either deep brain stimulation plus medical therapy, or medical therapy alone. (New England Journal of Medicine)
Report: 12 Years of Experience With Deep Brain Stimulation for Neuropathic Pain
Feb. 13, 2013 - International Neuromodulation Society member Alex Green, MD, and Tipu Aziz, FMedSci, of the University of Oxford report in Neurosurgery that deep brain stimulation (DBS) can lead to long-term improvement in pain scores and other outcomes. The researchers present information about 59 patients teated between 1999 and 2011. The authors conclude that up to four years later, 66% of patients significantly improved their health status. Treatment was beneficial for 89% for patients with amputation and 70% of those with stroke, compared to 50% of those with brachial plexus injury. The study accounts for about 5% of all reported patients treated worldwide with DBS for neuropathic pain. (Newswise)
INS Member Describes Deep Brain Stimulation Research in Alzheimer's Disease
Feb. 11, 2013 - International Neuromodulation Society North American chapter president Ali Rezai, MD, described deep brain stimulation research at Ohio State University that aims to slow the progress of Alzheimer's disease. In the research, an area of the frontal lobe is targeted. In different research, a team at Johns Hopkins University is looking at the fornix, which is involved in memory formation. The recently initiated study in Ohio will run two years. (Cleveland Plain Dealer)
Depression Scores Dropped in Most Study Subjects Who Received Transcranial Direct Current Stimulation and Antidepressant Therapy
Feb. 7, 2013 - In a study published Feb. 6 in JAMA Psychiatry, Dr. Felipe Fregni from the Harvard Medical School in Boston and Brazilian colleagues report that a combined treatment with antidepressant medication and transcranial direct current stimulation helped relieve symptoms in nearly two-thirds of patients after six weeks of treatment. Of 120 people in Brazil with moderate or severe depression, depression scores in the one-fourth of patients who received active combined stimulation and medication dropped to an average of 13 on a 0-to-60 scale. Before treatment study subjects' depression scores averaged 30 to 31. The untreated "sham" group's score dropped to 25 during the study. (Reuters)
National Institute of Neurological Disorders and Stroke Awards Phase I Grant to Company Developing Neurostimulation for Drug-Resistant Epilepsy
Feb. 5, 2013 - NeuroSigma, Inc. of California has received a Fast Track Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health to develop its implantable subcutaneous trigeminal nerve stimulation (sTNSTM) System. The company will receive $600,000 in Phase I, with $3 million in Phase II, dependent on the availability of funds and satisfactory progress. It is envisioned that patients who have drug-resistant epilepsy may chose to use an sTNSTM implant if their condition responds to external stimulation. The sTNSTM includes leads placed under the skin, but above the skull of the forehead and a pulse generator to be placed at the chest wall. (News-Medical.net)
Chronic Cluster Headache On-Demand Neurostimulation Treatment Results Published
Feb. 5, 2013 - International Neuromodulation Society member Ben Pless, president and chief executive officer of Autonomic Technologies, Inc., is quoted in a press release about results of a multi-center European study of the company's implant being developed to treat chronic cluster headache through on-demand stimulation of the sphenopalatine ganglion. As reported in Cephalalgia, the device was shown to be highly effective in achieving fast pain relief with acceptable safety profile compared to similar surgical procedures. The novel therapy also decreased attack frequency. In the study, patients received low- or no stimulation on a random basis for purposes of comparing controls in a blinded fashion. The experimental period was 30 attacks or eight weeks; 19 of 28 (68%) patients experienced a clinically significant improvement: seven (25%) achieved pain relief in ≥50% of treated attacks, 10 (36%), a ≥50% reduction in attack frequency, and two (7%), both. (Business Wire)
Shoulder Pain Therapy System Can Be Marketed in Europe
Feb. 5, 2013 - SPR Therapeutics LLC has received CE mark approval to sell its Smartpatch nerve stimulation system for use in patients with chronic shoulder pain. (Crains Cleveland Business)
External Supraorbital Nerve Stimulation May Decrease Migraine Episodes
Feb. 4, 2013 - A study based at Liège University in Belgium indicates that external supraorbital nerve stimulation delivered daily for 20 minutes at a time may help to prevent migraine. In the study, 67 patients were followed for three months in the treated or control arms of the trial. The group that received clinical stimulation doses had 2.1 fewer migraine days per month, while there was no change in the control group. (American Academy of Neurology)
Researchers Publish Phase II Results of External Trigeminal Nerve Stimulation in Epilepsy
Jan. 30, 2013 - International Neuromodulation Society member Ian Cook, MD, and colleagues at the University of California, Los Angeles and NeuroSigma, Inc., published results of a double-blind randomized active-control trial of 50 subjects who have drug-resistant epilepsy. The trail tested the suitability of external trigeminal nerve stimulation. The treatment group experienced a significant improvement in response over the 18-week treatment period, increasing from 17.8% at 6 weeks and 40.5% at 18 weeks. Overall 30.2% of the treatment group had a more than 50% reduction in seizure, compared to 21.1% for the active control group. The results will be used to design a larger, multi-center phase III clinical trial. (Neurology)
Researchers Consider Replacing Deep Brain Stimulation Leads with Micro Magnets
Feb. 1, 2013 - Preclinical brain stimulation magnetic implant research by International Medical Society member John T. Gale of the Cleveland Clinic and colleagues at Harvard Medical School was featured in a column based on their June 2012 publication in Nature Communications http://www.nature.com/ncomms/journal/v3/n6/full/ncomms1914.html (Scientific American Mind)
University Interviews Site Principal Investigator on Video About Study of Deep Brain Stimulation in Mild Alzheimer's Disease
Jan. 31, 2013 - The University of Florida in Gainesville is participating in Functional Neuromodulation Inc.'s 20-patient study of deep brain stimulation in mild Alzheimer's disease, and posted a short video interview of site principal investigator Dr. Michael Okun discussing the study goal of trying to slow memory loss through neuromodulation to the fornix. (University of Florida)
Web-Enbabled Dosing and Compliance Monitoring Described for Next-Generation Vagus Nerve Stimulation
January 30, 2013 - An article about potential treatments for acute illnesses with ElectroCore, Medical LLC's non-invasive vagus nerve stimulation system describes a next-generation device that would be rechargeable and web-enabled to receive refills and to communicate compliance and outcome information to the company, prescribing physicians, and insurance providers. The charging station would resemble an iTunes model that is web-enabled to provide additional doses that are downloaded after physician authorization. "This is the first example of a web refill," said J.P. Errico, founder of the New Jersey-based company. He explained the device, which is CE marked in Europe, relies on proprietary waveform and delivery technology to stimulate the vagus nerve through the skin. The company began patient enrollment at 10 U.S. centers in January for randomized, sham-controlled trial of chronic migraine prevention. (Medical Device Daily)
Deep Brain Stimulation is Said to Create a Niche for Neurologists in the Operating Room and Clinic
Jan. 29, 2013 - Since fellowships will likely evolve to include other technologies, and other nervous system regions beyond typical deep brain stimulation therapy, Drs. Anhar Hassan and Michael Okun suggest in an article for residents and fellows that a more accurate term for this potential niche of specialization for neurologists may be electrical neuro-network modulation. (Neurology)
Author Describes Future Vision of Neural Network Modulation
Jan. 31, 2013 - In response to letters accepted for publication about his October 2012 article on deep brain stimulation, Michael S. Okun, MD, of the University of Florida Center for Movement Disorders and Neurorestoration described an anticipated future of electrical neural-network modulation with the use of more leads and more targets per patient, especially as new symptoms emerge across various disease states; real-time monitoring of the inherent electrical signatures of the brain; more access to patients' personal electrical settings, so they may be able to “tune themselves"; telemedicine to improve satisfaction and to alleviate access problems; and the potential of coupling deep-brain stimulation to other therapies (such as gene therapy, the use of neurotrophic factors, and stem-cell therapy). In addition, he foresees hardware will become smaller and neurostimulator placement in the chest (with connector wires) will disappear, while leads may be coated to lessen infection risk. (New England Journal of Medicine)
Final Two Weeks: INS 11th World Congress Abstracts are due Feb. 14, 2013
Jan. 30, 2013 - Only two weeks remain to submit abstracts to the International Neuromodulation Society's 11th World Congress in Berlin, Germany, the preeminent scientific conference that covers all aspects of neuromodulation. Please view the preliminary program at http://bit.ly/INScongress and complete your submission through the abstract submission site at: http://ins-congress.abstractcentral.com/.
Vagus Nerve Stimulation to Be Investigated as Adjunct to Stroke Rehabilitation
Jan. 28, 2013 - Stroke researchers at Glagsow University are starting a clinical trial in which results of patients who receive vagus nerve stimulation during physiotherapy to improve arm movement will be compared to another group who receive stroke rehabilitation without the stimulation. The trail is using the Vivistim vagus nerve stimulation system being developed by Dallas-based Microtransponder Inc., which is sponsoring the study. (Herald Scotland)
German Team Reports Case of Deep Brain Stimulation Relieving Self-Injurious Behavior in a Patient with Autism
Jan. 25, 2013 - International Neuromodulation Society member Ali Rezai, MD, director of the Center for Neuromodulation at Wexner Medical Center in Ohio, was quoted as commenting on a published report about deep brain stimulation to the amygdaloid complex and supra-amygdaloid projection helping improve self-injurious behavior in an autistic patient whose case was reported in Frontiers in Neuroscience on Jan. 21. He was quoted as calling the patient's gains after 24 months "intriguing and promising". The authors report that the case supports a hypothesis about role of the amygdala, especially the basolateral part, in the pathogenesis of the condition. (Science News)
Signal Processing Expert Pursues Voice Analysis Project to Discern Indicators of Parkinson's Disease
Jan. 25, 2013 - An applied mathematician presents a concept-in-progress of using voice analysis to quickly and remotely spot potential signs of Parkinson's disease motor symptoms. The project director, Max Little, PhD, received his doctorate at the University of Oxford and became a Wellcome Trust/MIT fellow at the MIT Media Lab, where he applies his background in digital signal processing. The work is based on a dataset of 10,000 voices voluntarily provided by callers over the telephone. (TED)
India Hospital Adds Deep Brain Stimulation Surgery Services
Jan. 24, 2013 - A Parkinson's disease patient is reported to be the first to receive deep brain stimulation treatment in Gujaret, India. One member of the Sterling Hospitals surgical team, Dr. Paresh Doshi, previously conducted stereotactic and functional neurosurgery in Mumbai. He was quoted as calling India "the most sought-after and cost effective medical tourism destination of the world," saying costs are about 15% that of North America and the U.K. (Times of Udaipur)
Hospital Begins Offering Sacral Nerve Stimulation Services for Pediatric Patients with Treatment-resistant Urinary and/or Bowel Incontinence
Jan. 24, 2013 - Nationwide Children's Hospital in Columbus, Ohio now offers sacral nerve stimulation for the a small percentage of children with chronic incontinence of the bowel, bladder, or both who do not respond to medication or behavioral modification. (News-Medical.net)
Physicians Report Neurostimulation-Induced Instances of Sustained Herion Abstinence
Jan. 22, 2013 - Physicians at the University of Cologne in Germany report on two cases from a pilot phase of a clinical trial, "Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction (NASA)," in which deep brain stimulation of the nucleus accumbens led to sustained abstinence from heroin in two patient who had therapy-resistant opioid addiction. The report presents findings observed over 12 months in one patient and 24 months in the other. (Molecular Psychiatry)
Brain Scan Study of Parkinson's Patients Shows Impact of Subthalamic Nucleus Stimulation During Exercise
Jan. 22, 2013 - A positron-emission study of 12 Parkinson's disease patients at Hamamatsu University School of Medicine in Japan, published in the Journal of Cerebral Blood Flow and Metabolism, suggests beneficial effects of subthalamic nucleus stimulation in patients with Parkinson's disease are partly down to compensatory activation of non-motor dopamine pathways during exercise. (medwireNews)
Small-Business Grant Announced to Aid Deep Brain Stimulation System Programming for Parkinson's Disease
Jan. 22, 2013 - The National Institutes of Health, National Institute of Neurological Disorders and Stroke is funding a clinical feasibility study at the University of Alabama at Birmingham through a $283,828 Phase I Small Business Innovation Research grant to Cleveland, OH-based Great Lakes NeuroTechnologies to explore using intelligent algorithms to aid programming deep brain stimulation in Parkinson’s disease. The system will leverage existing technology to quantify Parkinson’s motor symptoms such as tremor, bradykinesia, and dyskinesia into a functional map. Intelligent algorithms will determine optimal parameters for symptom relief while minimizing side effects and battery consumption. (News-Medical.Net)
First Patient Receives Implant in U.S. Alzheimer's Disease Trial of Deep Brain Stimulation Surgery
Jan. 21, 2013 - The first U.S. patient has received a deep brain stimulation (DBS) implant in a clinical trial exploring DBS as a treatment option for early-state Alzheimer's disease according to an announcement by the Ohio State University's Wexner Medical Center, which calls the neuromodulation team at Ohio State pioneers in the use of DBS to treat Parkinson’s disease, as well as exploring the use of DBS for other neurological and neurobehavioral conditions. (Wexner Medical Center - Ohio State University)
Television Show Features Deep Brain Stimulation Surgery for Parkinson's Disease
Jan. 17, 2013 - International Neuromodulation Society member Brian Kopell, MD, was featured in a television segment about a patient's deep brain stimulation surgery for Parkinson's disease. Dr. Kopell likened it to receiving a brain pacemaker implant that could restore a more normal lifestyle, saying, "This is among the most technologically advanced surgeries that we do in medicine." (MYFOXNY)
Patent Application Proposes Smaller Pocket Controller for Neurostimulation Implant Patients' Use
January 2013 - International Neuromodulation Society members Michael Labbe and Jeff Gagnon are names as inventors on a patent application that was cleared for further review on Jan. 10, 2013. Also named as inventors were Steven E. Wilder and Ben Cottrill. Aside from turning on or adjusting neurostimulation to an implant, the application states, few patients use advanced controls to adjust program frequency and individual pulse/area stimulation features such as pulse width. Since hand-held controllers are slightly large for readily carrying in a pocket, the application proposes creation of a smaller pocket controller to provide the main options while a patient is on the go, along with an integrated controller-charger and charging module as part of the set. The patent is assigned to Greatbatch, Inc. (Equities.com)
Deep Brain Stimulation Surgery for One Patient is Described in Article for Alzheimer's Research Audience
Jan. 13, 2013 - International Neuromodulation Society member Antonio De Salles, MD, PhD, who directs the Stereotactic Surgery program at the University of California, Los Angeles, is profiled in a detailed description of a patient undergoing deep brain stimulation (DBS) surgery for Parkinson's disease. The article also summarizes recent research into DBS as a potential intervention in early-stage Alzheimer's disease. (Alzheimer Research Forum)
Feasibility Study Shows Telepresence Robot Can Aid Neuromodulation Programming Sessions
Jan. 16, 2013 - International Neuromodulation Society member Ivar Mendez, MD, PhD was featured in an article about a feasibility study showing that neuromodulation device programming can be guided remotely by an expert using a telepresence robot with a digital camera, microphones, and laptop interface, as well as an arm that can remotely indicate which buttons to push on the programming screen. A preliminary study he led showed no significant difference in accuracy or clinical outcomes between 10 programming sessions carried out remotely and 10 performed by an expert in person. (Medical Xpress)
Vagus Nerve Stimulation Yielded Improvements in Depression Scores in Small Italian Study
Jan. 8, 2013 - A study of six patients with treatment-resistant depression who received vagus nerve stimulation (VNS) was published by the Departments of Psychiatry and Mental Health, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, University of Milan. The patients were followed for at least 12 months. After three months, the patients showed statistically significant improvements in depression scores, and after 12 months, they also showed improvements in depression rating scales as well as in clinical global impression. Also, the patients showed an overall favorable tolerability to the VNS implant. (The Journal of ECT)
Brazilian Team Publishes Protocol for Randomized Trial of Transcutaneous Electrical Nerve Stimulation in Organ Donors
Jan. 11, 2013 - Hypothesizing that transcutaneous electrical nerve stimulation (TENS) in kidney donors may aid postoperative pain relief, pulmonary function and mobility, a research team at the
Physical Therapy Department, University of the City of Sao Paulo in Brazil has published a protocol for a prospective, randomized trial using sham or active TENS in 74 patients. The trial is registered under the Registro Brasileiro de Ensaios Clinicos (ReBEC), number RBR-8xtkjp. (BMC Nephrology)
University Announces Grant for Brain Stimulation Research Laboratory
January 2013 - Iowa State University will receive $395,280, to establish a laboratory for brain stimulation research, from the Roy J. Carver Charitable Trust of Muscatine, Iowa. One of the goals is to find noninvasive methods of stimulating deep-lying regions of the brain to potentially treat a wide range of issues – from concussion, depression and post-traumatic stress disorder, to degenerative issues such as Parkinson’s disease and stroke. (Iowa State University Foundation)
Some 1,500 Attendees Expected at INS 11th World Congress in June in Berlin
Jan. 9, 2013 - More than 1,500 attendees are expected at the INS 11th World Congress in Berlin in June that centers on all aspects of development of therapeutic applications of neuromodulation. (Newswise)
The INS 11th World Congress Abstract Deadline is Now Feb. 14, 2013
Jan. 8, 2013 - The INS 11th World Congress that takes place June 8 - 13 in Berlin, "Neuromodulation: Technology Transforming Chronic Illness Management," is extending the abstract submission deadline by one month to 14 February 2013. This final deadline will have no further extensions. (INS)
Winter INS Newsletter Informs Members About Chapter Activities Worldwide
Jan. 8, 2013 - The winter newsletter of the INS is now online, featuring a president's message, updates, and annual chapter recaps, including news that Japan now covers the cost of deep brain stimulation and spinal cord stimulation procedures. (INS)
INS and Touch Medical Media Partner to Publicize Neuromodulation Research
Jan. 8, 2013 - INS is entering into a media partnership with Touch Medical Media, which publishes the European Neurological Review. INS may distribute information to members from them later, and the organization will also list the INS logo, contact information, and link on its website, www.neurology.com. (INS)
Pain Intensity Study Points to Role of Secondary Somatosensory Cortex in Perception of Nociception
Jan. 7, 2013 - Researchers at the University College London report on a study that suggests the secondary somatosensory cortex (S2) plays a causal role for encoding pain intensity. They applied single-pulse transcranial magnetic stimulation (TMS) to the contralateral S2 120 milliseconds after a painful stimulus was delivered to nociceptive afferents using neodymium:yttrium–aluminium–perovskite (Nd:YAP) laser pulses. Compared to other areas receiving TMS stimulation during the trial, when S2 was stimulated, study subjects perceived the pain as less intense. (Cortex)
University of Minnesota to Seek Research Investment in Neuromodulation
January 2013 - In recent years, the University of Minnesota has been ramping up its investment in neuromodulation, noting that the state is already home to market leader Medtronic, Inc., and total sales from neuromodulation are expected to rise to nearly $15 billion worldwide within five or six years. With proper investment, the university's alumni publication states, Minnesota could find itself at the forefront of that growth. (University of Minnesota)
Sacral Nerve Stimulation Retrospective Analysis: Spot Lead Failures by Checking Impedance
Jan. 1, 2013 - Measuring impedance in office follow-up visits can help to spot if effectiveness is hampered not by lead position, but instead by open- or short-circuit failures in sacral nerve stimulation implants, according to research presented at the 2012 American Urological Association meeting by medical researchers at Case Western Reserve University. (Urology Times via Modern Medicine)
Newspaper Covers Early Report of Transcranial Direct Current Stimulation in Migraine
Jan. 4, 2013 - The Daily Mail reports on an early-stage study of transcranial direct current stimulation in 13 migraineurs, led by an assistant professor at the University of Michigan School of Dentistry. After four weeks of repeated sessions of stimulation to the motor cortex, the subjects' average pain threshold increased 37%, according to the report of the study published in the journal Headache. Computational modeling by the collaborators indicated deeper brain structures were also affected by the stimulation. (Daily Mail)
Article Features High-Frequency Spinal Cord Stimulation Trial for Back Pain
Jan. 2, 2013 - In an interview about the Nevro SENZA high-frequency spinal cord stimulation system, International Neuromodulation Society member Adnan Al-Kaisy, MB ChB FRCA, said back-pain patients accepted into a clinical trial of the system at Guy's and St. Thomas' Hospital in London first participate in a residential program that involves cognitive behavior therapy, relaxation and learning to reduce their pain medication. The article notes that 100 patients have been implanted there with the system to date. (Daily Mail)
Device Complications 
Article Explains More About Ranking of Deep Brain Stimulation Lead Cap RecallMay 6, 2013 - International Neuromodulation Society North American Chapter President Ali Rezai, MD was quoted in an article about recall of an optional cap for deep brain stimulation leads, ranked Class 1 by the FDA, saying it would be incorrect to interpret the recall as representing a life-threatening concern -- the maximum consequence under that ranking. The article explained that the cap, which he said he does not use and few other neurosurgeons do, is intended to cover the end of the leads before they are connected to a pulse generator, and may cause lead damage if the cap is twisted or its screw is over-tightened. Lead damage would likely be noticed during the connection step, and the likely result of lead damage would be that the patient would not receive the full benefit of therapy to control symptoms, a result that might be life-threatening in a cardiac arrest treated with a defibrillator, but not when controlling tremor and stiffness of Parkinson's disease or other motor disorders. (Mass Device)
Company Issues Urgent Medical Device Correction Notice on Deep Brain Stimulation Lead CapsMay 2, 2013 - Medtronic, Inc. announced it issued an Urgent Medical Device Correction notification in February to inform physicians about the potential for temporary caps sometimes used on deep brain stimulation (DBS) leads to cause twisting damage to the lead. Medtronic received reports of DBS leads being damaged due to twisting of the connector within the lead cap, which is sometimes used to temporarily protect the end of a DBS lead after implantation. The FDA classified the notification a Class 1 Recall. A manufacturing change intended to address the issue is currently under FDA review, and in the meantime Medtronic has issued modified instructions to physicians who may use DBS lead caps. Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 1-800-707-0933, weekdays from 7 a.m. to 6 p.m. CST, and the FDA's MedWatch Program at http://www.fda.gov/MedWatch. (Wall Street Journal)
Japan Team Finds Short Circuits in Deep Brain Stimulation Patients
Sept. 7, 2012 - After following nearly 80 patients for a year who had received deep brain stimulation (DBS) surgery, a clinical research team in Japan determined that 7 (8.9%) had developed short circuits and conclude that short circuits in DBS may be higher than previously thought, especially in cases in which leads are anchored with miniplates. The results stem from their new institutional policy of routinely evaluating impendence at every follow-up visit of DBS patients, regardless of the presence of symptoms. The researchers say short circuits could cause insidious development of neurological symptoms through limited or extended potential fields as well as shortened battery life. (American Journal of Neurological Surgeons)
Battery Issues Lead to Recall of Some Devices
Aug. 12, 2012 - St. Jude Medical Inc. alerted doctors and patients on July 31, 2012 that it is recalling some of its Eon and Eon Mini devices following reports of battery issues. (The Legal Examiner Charlottesville)
Urgent Safety Action Notice for CareFusion's NicoletOne Products
February 23, 2012 - In an action affecting 132 devices and 35 software licenses, CareFusion is recalling Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator. The products were manufactured from May 2009 - July 2011 for functional brain-mapping of patients with seizure disorders and brain tumors. The software incorrectly indicates stimulation is delivered to a different electrode than the one selected, and a short circuit may develop. (FDA)
Rare Case of Pulse Generator Corrosion Reported
2011 - Drs. Philip V. Parry and Douglas Kondziolka, of the Department Neurological Surgery, University of Pittsburgh, report a case of a patient who developed granulation tissue around a pulse generator that had been implanted 15 months prior, at a different institution, for vagus nerve stimulation treatment for epilepsy. In their report, they indicate the generator power had depleted early and the pulse generator showed corrosion at the electrode-generator connection. Upon surgical removal, the lead broke at its location just beneath the patient's clavicle. (World Science)
SynchroMed II Pump Model 8637 is Recalled Over Battery Defect
August 30, 2011 - Medtronic's SynchroMed II, model 8637, implantable pump has been recalled due to a problem that has caused some batteries to abruptly cease working. The FDA has approved a modification to the battery, designed to prevent the problem from occurring in pumps with the new battery; all Synchromed II pumps are being manufactured with the new battery. Updated 9/1/11 (Mass Device)
Government and Regulatory Issues
Overview of Proposed Active Implantable Device Regulations for European Union
May 30, 2013 - The European Union's proposed regulation of active implantable devices has clarified definitions; an active device relies on a source of power, which includes standalone software, while an implantable device is one that is intended to remain in place for at least 30 days. Demonstrating equivalence with another device would not generally be considered sufficient without gathering clinical data and clinical trials would be subject to a unified electronic system. (Mondaq)
Court Rules Italy Must Redesign Cuts to Medical Device CostsMay 14, 2013 - An Italian government move to cut prices for medical devices was invalidated in a court ruling that found the program, which had been scheduled to go into effect in January, was based on faulty use of a national medical device classification system and used inaccurate price sampling. Italian health care authorities must now come up with a different formula for implementing cost controls that recognizes the varied and specialized characteristics of the medtech sector, Clinica reported. (AdvaMed) Proposed European Premarket Authorization of Medical Devices Questioned May 13, 2013 - Clinica reports that two experts -- Erik Vollebregt of Axon Lawyers and Mika Reinikainen of AbNovo consultants -- believe that the European Parliament's proposal for pre-market authorization for medical devices would most likely be unwieldy if approved, but the politics of the issue are murky and the outcome of the debate unpredictable. Reinikainen believes the EU would do better to improve the current system, and Vollebregt added that the proposal is hostile to innovation by assuming that anything innovative carries more risk. (AdvaMed)
April 24, 2013 - The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on occipital nerve stimulation (ONS) for intractable chronic migraine. Selection of patients for treatment using ONS for intractable chronic migraine should be done by a multidisciplinary team, including specialists in headache, pain management and neurosurgery. Clinicians should enter details about all patients undergoing ONS for intractable chronic migraine onto the UK Neuromodulation Register when access to that database is available. NICE encourages publication of further information from comparative studies and from collaborative data collection to guide future use of this procedure and to provide patients with the best possible advice. Publications should include full details of any complications, and of adjunctive or subsequent treatments. Outcomes should include measures of pain, function and quality of life, particularly in the long term. (NICE)
Comment Sought on Proposed Revisions of Implantable Device Review in AustraliaJanuary 2013 - Through March 15, the Therapeutic Goods Administration in Australia is seeking comment on proposed revisions to its premarket review process for medical devices, including subjecting surgically invasive and implantable systems designed for long-term use to the agency's mandatory application audit and easing its lower-risk device rules. (Australian Therapeutic Goods Administration)
French Agency Seeks Input Prior to Updating Reimbursement of Neurostimulation Devices for Chronic PainJanuary 16, 2013 - At the request of the Ministry of Health, France's cost containment agency (HAS) will publish a notice for public comment seeking input from all stakeholders including patients on an updated reimbursement list for neurostimulation devices, based on an assessment of each device’s effectiveness and the value of its therapeutic indications. HAS is undertaking a health technology assessment review of all implantable spinal neurostimulation devices, whether rechargeable or not, that are intended for the treatment of chronic pain and on the list of Reimbursable Products and Services. (Regulatory Focus) Dutch Ministry of Health to Establish Device Registry to Track ComplicationsJanuary 2013 - The Dutch Ministry of Health plans a national registry for patients who have received medical implants. In it, suppliers, producers, and insurance companies will be required to provide information on any device complications. (Dutch News via The Commonwealth Fund)
European Union Publishes Proposed Medical Device Regulations Sept. 27, 2012 - Active implantable devices will be Class III devices under proposed regulations from the European Commission, intended to replace the current Medical Devices Directive, Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive. (Doanwa.com)
FDA Solicits Opinions on Post-Market Medical Device Surveillance UpdatesSept. 7, 2012 - The FDA is seeking comment (through FDA.gov) on four post-market medical device surveillance proposals, as reported in Healthcare Finance News: 1. Establish a unique device identification system and promote its incorporation into electronic health information. 2. Promote the development of national and international device registries for selected products. 3. Modernize adverse event reporting and analysis. 4. Develop and use new methods for evidence generation, synthesis and appraisal. (Healthcare Finance News)
FDA Panel Recommends Humanitarian Device Exemption for Retinal Prosthesis
Oct. 1, 2012 - An FDA advisory panel recommended that the Argus II retinal prosthesis system by Second Sight Medical receive a humanitarian device exemption for patients who are severely blind due to the rare condition retinitis pigmentosa. The panel did raise questions about long-term safety, and called for continued study, according to a Mass Device article Sept. 27. (Mass Device)
European Union Publishes Regulations and Future Clinical Trial Mechanisms Regarding Medical Devices
Sept. 28, 2012 - The European Commission has published a "scrutiny mechanism" allowing input by authorities before medical devices go to market; also, its new proposals allow for a future, electronic, single clinical trial application for studies conducted in more than one member state. (AdvaMed SmartBrief)
Study Documents Benefits of Vagus Nerve Stimulation for Medicare Patients with Treatment-Resistant Depression
Sept. 6, 2012 - A retrospective analysis of Medicare claims from 2006-2009 comparing patients with managed depression, treatment-resistant depression, and those receiving vagus nerve stimulation (VNS) treatment indicates that carefully screened patients who have failed other therapies can respond to VNS treatment while costing the system less post-implantation. (Journal of Medical Economics)
Company Executive Discloses FDA Warning Letter About Processes for Handling Complaints
Aug. 21, 2012 - Medtronic Inc. was reported to have disclosed in a conference call that its neuromodulation device business received an FDA warning letter related mainly to its process for handling complaints. Overall, the company reported quarterly earnings in line with expectations during the same conference call. (Capital)
Argentinean Paper Highlights Regional Neuromodulation Initiative
Aug. 28, 2012 - International Neuromodulation Society members Fabian Piedimonte, MD, and Juan Carlos Andreani, MD, were mentioned as coordinating a new provincial neuromodulation treatment initiative announced by Health Minister Alejandro Collie at the second joint meeting of the Argentinian and Brazilian neuromodulation societies. They are president and vice president, respectively, of the Argentinean INS chapter, Sociedad Argentina de Neuromodulación (SANE). The meeting in Buenos Aires also involved INS President-Elect Tim Deer, MD, and Osvaldo Viela Filho, MD, PhD, president of the Brazilian chapter. (El Sol)
FDA Allows Clinical Trial Recruitment of Ischemic Stroke Patients
July 26, 2012 - Recruitment in the U.S. can begin for a clinical trial that examines the utility of electrical stimulation of the sphenopalatine ganglion to increase cerebral blood flow in the treatment of ischemic stroke (stroke caused by a blockage to blood flow). The approach aims to expand the treatment window which currently limits how many patients receive timely treatment. The trial was started at 57 medical centers in June 2011 by Israel-based BrainsGate Ltd., and involved 176 patients to date outside the U.S. With FDA permission to recruit clinical trial subjects in the U.S., the company expects to complete the trial on 450 patients in the fourth quarter of 2013. (Globes)
Under Proposed Regulatory Revision, Japan May Separate Device Approvals from the Drug Approval Process
July 2, 2012 - A proposed regulatory structure that separates medical devices from drugs is expected to be presented to the Japanese Diet when it reconvenes in January. (Clinica via AdvaMed SmartBrief)
Medicare Changes to Only Covering Transcutaneous Electrical Nerve Stimulation for Clinical Trials
June 11, 2012 -- The Centers for Medicare and Medicaid Services will no longer cover most uses of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain, based a on a review prompted by a 2010 report by an American Academy of Neurology panel that found published reports presented conflicting evidence of effectiveness. The agency will cover randomized clinical trials of TENS for three years. (MedPage Today)
FDA Gives Clearance for Randomized Controlled Trial of High-Frequency Spinal Cord Stimulation
May 23, 2012 - International Neuromodulation Society (INS) member Leonardo Kapural, M.D., Ph.D, will be principal investigator for a U.S. randomized trial of high-frequency spinal cord stimulation, which is designed to provide chronic pain relief without the tingling, pins-and-needles feeling of parasthesia. Nervo Corp. announced FDA approval of the trial, SENZA-RCT, which will enroll up to 300 patients at 15 centers. An earlier prospective study in Europe, where the device is approved for marketing, showed effectiveness in reducing hard-to-treat back pain, according to results presented at the North American Neuromodulation Society's 2011 annual meeting by Jean-Pierre Van Buyten, M.D., chairman of the Multidisciplinary Pain Center AZ Nikolaas Sint-Niklaas, Belgium, who is also a member of the INS. (BusinessWire)
Regional Medicare Contractor will Cover Posterior Tibial Nerve Stimulation for Overactive Bladder
April 26, 2012 - Novitas Solutions, the Medicare administrative contractor for approximately 4.6 million Medicare beneficiaries in Delaware, Maryland, New Jersey, Pennsylvania and the District of Columbia, will cover posterior tibial nerve stimulation (PTNS) services provided on or after April 9, 2012, based on a recent comparative effectiveness review entitled "Nonsurgical Treatments for Urinary Incontinence in Adult Women," published by the Agency for Healthcare Research and Quality (AHRQ), Uroplasty, Inc. announced in a press release. The company provides a minimally invasive PTNS treatment system, Urgent PC, for office-based treatment of overactive bladder and the associated symptoms of urgency, frequency and urge incontinence.(MarketWatch)
Brain Simulation Effort Reportedly Short-listed for a £1billion European Union grant
April 17, 2012 - An international effort to simulate the complexity of a human brain down to the level of individual cells and molecules has been short-listed for a £1billion grant from the European Union. Led by Professor Henry Markram, Head of the neural microcircuitry laboratory at the Ecole Polytechnique Federale de Lausanne based in Switzerland, the simulation is intended to provide new insights into neurological diseases such as autism, depression, Parkinson's, and Alzheimer's, new ways of testing drugs and understanding the way they work, and to allow the scientists to design prosthetic devices to help people with disabilities. (International Business Times)
New England Region's Success in Gaining Reimbursement for Depression Treatment Recounted
March 30, 2012 - A Providence, R.I., newspaper article recounts three years of advocacy for reimbursement since the FDA approved repetitive transcranial magnetic stimulation (rTMS) for treatment of major depressive disorder in adult patients for whom traditional therapies have failed. In March, New England became the first region in the nation to put into effect a positive Medicare decision for covering this treatment. (PBN.com)
Medtronic Receives Health Canada Approval for Deep Brain Stimulation to Treat Refractory Epilepsy
March 15, 2012 - Medtronic, Inc. has received a Health Canada license for its deep brain stimulation (DBS) therapy for treatment-resistant epilepsy. The approval was based on Medtronic's clinical trial at 17 U.S. centers of 110 patients with medically refractory epilepsy with partial-onset seizures. The prospective, randomized, double-blind study, SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) examined the delivery of controlled electrical pulses to an area of the brain involved in seizures. Medtronic's DBS therapy for refractory epilepsy is also approved in Europe. (Medtronic)
Medicare May Deny Most Coverage for Transcutaneous Electrical Nerve Stimulation
March 14, 2012 - The Centers for Medicare and Medicaid Services issued a proposed decision memo advising that reimbursements for transcutaneous electrical nerve stimulation (TENS) should be available only for patients participating in randomized trials. In 2010 a research review by a panel of the American Academy of Neurology concluded the treatment was not proven effective for treating chronic low-back pain. Medicare currently covers FDA-approved TENS equipment and supplies when prescribed for chronic intractable pain, and provides reimbursement for physicians and physical therapists to assess patients' suitability for the treatment, which is typically done at home. (MedPage Today)
Obstructive Sleep Apnea Therapy Using Hypoglossal Nerve Stimulation Receives European Approval
March 14, 2012 - ImThera Medical Inc. has received European CE Mark approval to market its aura6000 (™) system for the treatment of obstructive sleep apnea. The system uses a patented method of hypoglossal nerve stimulation. (MarketWatch)
U.S. Consumer Group Urges Tight Controls on Cranial Electrotherapy Stimulators
March 1, 2012 - Following up on a poster presentation from the 2009 meeting of the North American Neuromodulation Society, a chapter of the INS, an Ohio-based clinical team has published a two-year followup case of using spinal cord stimulation to manage post-surgical pain following lung cancer surgery. The patient reported improved quality of life and more than 75% reduction in pain. (Pain Management Nursing)
Ireland Debates Providing Its Own Deep Brain Stimulation Service, Appoints an Assessment Panel
January 27, 2012 - Ireland's publicly funded Health Service Executive has asked for a health technology assessment about providing a national Deep Brain Stimulation service. The assessment by the nation's Health Information and Quality Authority will focus on developing a standard for the provision of such a service in Ireland (including staffing, equipment and other resources) and will evaluate the associated costs. It will then compare these with the current arrangements where eligible patients are referred, under the Treatment Abroad Scheme, to centers outside of Ireland for the surgery. (Health Information and Quality Authority)
Researchers at Northwestern University Report that Three-Quarters of Medical Device Makers First Seek Regulatory Approval Outside of the U.S.
October 6, 2011 - The study, funded by the Institute for Health Technology Studies, citied that the FDA's lengthy and complicated 501(k) review process as well as the associated costs has led device companies to seek approval overseas before applying for FDA approval. (Mass Device)
U.S. Institute of Medicine's (IOM) Report on Chronic Pain Holds Promise for Neuromodulation Therapy Research and Patient Access
July 14, 2011 - Mandated by President Obama’s healthcare reform law, the IOM's report stressed the importance of improving research and treatment of chronic pain, providing "a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America.” Xconomy Boston followed-up with a commentary, explaining how the report may also aid research and development in the medical device industry. (IOM Report, Xconomy Boston)
FDA Device Panel Considers Design of Clinical Trials for Treatment of Depression
October 11, 2010 - The Neurological Devices Panel met to advise the US Food and Drug Administration (FDA) about the design of clinical trials of devices to treat severe depression. Though no firm recommendations were made, the panel considered several ethical issues, including the number of attempted and completed suicides in the patient population, the need for control groups, and acceptable response rates. (MedScape Today)
FDA Might Require Pump Manufacturers to Provide More Data
April 23, 2010 - The FDA issued preliminary guidelines that will require pump manufacturers to submit more test data, before the devices are approved for use. In addition, the companies would need to conduct limited clinical trials. (New York Times - requires registration)
The Council of Medical Specialty Societies Develops New Code of Ethics for Physician Interactions with Industry
April 21, 2010 - The council, which includes 32 medical societies, developed the code of ethics, which calls for greater transparency and for limiting the influence that drug and device companies have over patient care. (Associated Press)
FDA's Center for Devices and Radiological Health (CDRH) Launches New Transparency Website
April 20, 2010 - The FDA is providing information to help the public understand its regulatory decisions, and descriptions of regulatory processes. The new site also includes databases for premarket approvals and recalls and guidance documents. (FDA)
Improving the Security and Privacy of Implantable Medical Devices
April 2, 2010 - In a perspective article published in The New England Journal of Medicine, researchers make a case for risk-based security assessment to be included in premarket regulatory evaluation of devices. (MedPage Today)
Device Firms Seek Definition Of "New Science," As FDA Mulls Policy Changes
March 11, 2010 - FDA must better define what it considers "new science" when deciding how to incorporate emerging data into product reviews and post-market surveillance, and must vet the data carefully before reacting, device companies say. (Medical Devices Today)
NHS urged to buy Fairtrade and ethically sourced kit
February 27, 2010 - A new campaign has been launched to put pressure on the NHS to examine where its medical instruments come from. The British Medical Association (BMA) wants more Fairtrade and ethically sourced kit to be used. (BBC News)
Massachusetts medical device firms hurt by gift ban
February 26, 2010 - The Massachusetts law designed to prevent pharmaceutical and medical device firms from having undue influence on doctors is spurring job losses at local companies and research institutions, industry insiders claim. (Mass High Tech; The Journal of New England Technology)
Italy publishes long-awaited medical device regulations update
February 2, 2010 - Italian medical device regulations are about to come into force, featuring a May 5 deadline for the registration of products. A health ministry decree (DM) of December 21 2009, just published, comes into force on February 6, "replacing entirely" the February 20 2007 DM that currently regulates . (Requires a subscription on www.Clinica.co.uk)
Obama Budget Request Would Fund National Device Registry At FDA
February 8, 2009 - The Obama administration's fiscal year 2011 budget request includes $4 million for a new medical device registry that would link unique device identifiers to electronic health data. The registry would be designed and built by FDA. (Medical Devices Today)
Industry News
U.S. Clinical Trial of Deep Brain Stimulation System Starts
June 17, 2013 - Boston Scientific Corporation announced the first U.S. patient has been implanted with the Vercise deep brain stimulation system for the treatment of Parkinson's disease at Cedars-Sinai Medical Center in a prospective, multi-center, double-blinded, randomized, controlled study, INTREPID, to evaluate the safety and effectiveness of motor function and overall quality of life.
Developing Neurostimulation Technology Receives $3 Million Commercialization Grant
June 18, 2013 - The Ohio Third Frontier Commission has awarded a $3 million grant to Case Western Reserve University to commercialize a neurostimulation technology in collaboration with NDI Medical LLC, SPR Therapeutics and Valtronic. Developed over the past decade, the platform is designed to treat indications ranging from pain to muscle paralysis. (Healio)
Heart Failure Neuromodulation Startup Receives Venture Capital Funding
June 13, 2013 - NeuroTronik of Chapel Hill, N.C. received $13.1 million from a venture capital syndicate led by Hatteras Venture Partners to develop its neuromodulation system to treat heart failure by improving pumping effectiveness. (News & Observer)
Equity Investment in Dorsal Root Ganglion-Targeted Spinal Cord Stimulation Therapy Yields Distribution Rights, Future Acquisition Option
June 7, 2013 - St. Jude Medical announced it has made a $40 million equity investment in Spinal Modulation, Inc. and acquired exclusive international distribution rights for the Menlo Park, Calif.-based company's CE Mark-approved Axium Neurostimulator. The system’s leads are placed at the dorsal root ganglion and provide targeted stimulation to areas that are typically hard to treat – including the lower leg, foot and groin – consuming approximately 95 percent less power than traditional spinal cord stimulation therapy. St. Jude will also have an exclusive option to acquire Spinal Modulation for up to $300 million plus certain revenue-based milestones following U.S. commercialization. (St. Jude)
INS 11th World Congress and New Research Investments Featured in News Article About Expanded Inquiry into Neuromodulation Therapies
June 2013 - Mounting evidence for electrical stimulation therapy is fueling expanded investigation into new indications, according to a news feature in Nature Medicine that quotes International Neuromodulation Society (INS) member Kristoffer Famm, head of bioelectronics research and development at GlaxoSmithKline, which recently announced an initiative to fund up to 20 external research projects in so-called electroceuticals. The article references research presentations at the INS 11th World Congress June 8 - 13 in Berlin on clinical trials of electrical stimulation therapy in fibromyalgia and refractory angina. (Nature Medicine)
Company Launches Integrated Lead-to-Pulse-Generator Interconnect for Implantable Neurostimulators at INS 11th World Congress
June 4, 2013 - The first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator devices will be featured at the International Neuromodulation Society's 11th World Congress in Berlin June 8-13 at the Evergreen Medical Technology booth. The system, Encompass, is versatile and enables rapid product development; it has a port-entry screw-anchor mechanism and three lead strain relief seal options for transition from the header port. A slot is molded into the header for the placement of a radiopaque identifier and a suture hole is included. The header has been designed with a set of two anchors to firmly attach the header to the hermetic enclosure. (Fort Mill Times)
U.S. Shipments of Transcranial Magnetic Stimulation Systems Are Set to Start
June 3, 2013 - Brainsway is poised to begin shipping its Deep TMS (transcranial magnetic stimulation) system to the U.S. where the company received clearance for marketing it for drug-resistant major depressive disorder. The system is also approved in Europe for addressing neuropathic chronic pain, bipolar disorder, and schizophrenia. Using a special helmet to target specific regions of the brain, treatment is conducted in an outpatient setting during 20-minute sessions over a four week period. (MedGadget)
May 30, 2013 - Minnetonka, Minnesota-based Uroplasty, Inc. announced fourth-quarter and fiscal year performance for the period ended March 31, 2013. For the full year, sales grew $1.9 million to $22.4 million, reflecting an 18% increase in U.S. sales and a 10% decrease in sales outside the U.S. Fiscal fourth quarter 2013 sales in the U.S. increased 2%, driven by an 11% increase in sales of the Urgent® PC Neuromodulation System, compared with fiscal fourth quarter a year ago. The company also announced that as of June 1, 2013, the Medicare administrative contractor Wisconsin Physicians Services (WPS) will begin coverage for posterior tibial nerve stimulation for treatment of overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence. WPS provides medical and drug benefits to approximately 8.7 million Medicare beneficiaries in Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska and Wisconsin. (PR Newswire)
Company's 25 Years Addressing Epilepsy is DescribedMay 28, 2013 - Cyberonics, Inc. is developing its sixth-generation VNS device, AspireSR, to monitor heart rate for signs on an impending epileptic seizure, and despite competition, still dominates the market for epilepsy, according to a news feature in Xconomy. (Xconomy) Neuromodulation Business Leader is HonoredMay 28, 2013 - Medtronic, Inc.'s vice president and general manager of the Gastro/Urology Therapies business for the Neuromodulation Division, Cindy Kent, was named one of eight Women of Distinction by the Girl Scouts of Minnesota and Wisconsin River Valleys. (ABC Newspapers)
Deep Brain Stimulation Visualization System Receives CE Mark ApprovalMay 27, 2013 - Boston Scientific Corporation has received CE Mark approval for use of its deep brain stimulation visualization system, Guide DBS, in Parkinson's disease. The tool allows physicians to visualize the relative position of the lead and model stimulation fields and output. Designed to help reduce programming time and tailor stimulation therapy, the system is the first commercial product resulting from the company's acquisition of Intelect Medical in 2011. (PR Newswire)
May 23, 2013 - Venture and commercialization firm NDI Medical launched a new portfolio company, Deep Brain Innovations, LLC, to commercialize its Temporally Optimized Patterned Stimulation (TOPS™) technology that delivers novel, more efficient, patterns of stimulation, allowing smaller and longer-lasting devices. (Digital Journal)
Neuromodulation Growth Reported in Company Earnings ReportApril 25, 2013 - Boston Scientific announced global year-over-year revenue growth of 6 percent in neuromodulation and combined revenue in the countries of Brazil, Russia, India and China 35 percent year-over-year, while taking a write down of $422 million related to the 2006 acquisition of Guidant Corp. for $28 billion. Overall adjusted earnings per share were $0.16 for the first quarter ended March 31, 2013, on revenue of $1.761 billion. (Sacramento Bee)
Study of Spine Surgery Records Finds Low Utilization of Spinal Cord StimulationApril 2013 - Researchers specializing in spinal cord stimulation (SCS) reviewed records of 16,455 spine surgery patients who had continued chronic pain -- so-called Failed Back Surgery Syndrome -- and found only 2.4% of those underwent SCS implantation from 2000 - 2099, according to a study presented at the 2012 annual meeting of the North American Neuromodulation Society. Surgeons should be more aware that SCS may be superior to repeat surgery in select patients, said study co-author Nandan Lad, MD, PhD, a member of the International Neuromodulation Society and assistant professor of neurosurgery, Duke University School of Medicine. (Anesthesiology News) 2013 Directory of Neuromodulation Products Being Published and Will Be Free to INS World Congress AttendeesApril 2013 - Neurotech Reports, the publisher of Neurotech Business Report, will publish the 2013 Directory of Neuromodulation Products later this year. The print directory will be given to each attendee at the 11th World Congress of the International Neuromodulation Society (INS), which takes place June 8-13, in Berlin, Germany, and attracts more than 1,500 clinicians, engineers, researchers and entrepreneurs to hear an internationally renowned faculty address the most comprehensive breadth of all neuromodulation therapies. For more information, contact Neurotech Reports at 415 546 1259 or visit this link: http://www.neurotechreports.com/pages/2013_Directory_Neuromodulation_Products.html (Neurotech Reports)
INS Accepts Record Number of Abstracts for Biennial Congress
April 19, 2013 - The International Neuromodulation has accepted a record number of abstracts for its 11th World Congress June 8 - 13 in Berlin. Diverse highlights are previewed in a news announcement issued today. INS also announced a pre-conference innovation-and-investment summit. (Newswise)
Company Sees First-Quarter Earnings Dip, But Strong Year-Ahead ProspectsApril 17, 2013 - St. Jude Medical sales of neuromodulation products were $99 million in the first quarter of 2013, down 4 percent from the prior year. Overall, partly due to unfavorable currency translations, the company reported net sales of $1.338 billion in the first quarter of 2013, a decline of approximately 4 percent compared with the first quarter of 2012. With more than 20 diverse products due to launch in 2013, the company expects full-year 2013 consolidated net earnings to be in the range of $3.68 to $3.73. (Wall Street Journal)
Deep Brain Stimulation Service Comes to BangaloreApril 17, 2013 - Commenting on a new deep brain stimulation service for Parkinson's disease patients in Bangalore, a neurologist calls the procedure a good option in carefully selected patients. The Columbia Asia Referral Hospital in Yeshwanthpur is one of more than 20 medical facilities in India and Southeast Asia operated by Columbia Asia Group, which entered the country with 100 percent foreign investment. (Moneylife)
Company to Launch Anchoring Technology for Spinal Cord Stimulation Leads and Pain Pump Catheters
April 15, 2013 - Boston Scientific Corporation announced it has acquired and is launching the Fixate Tissue Band for spinal cord stimulator leads and pain pump catheters. Anulex Technologies of Minnetonka, MN developed the device to secure leads to the fascia or inter-spinous/supra-spinous ligament, and received expanded FDA approval last year for the catheter application. International Neuromodulation Society member Richard Bowman, MD, commented that the device permits quick and efficient lead anchoring. (Implantable Medical Devices)
A Limited U.S. Launch of Spinal Cord Stimulation System with Three-Dimensional Software Control
April 12, 2013 - Boston Scientific Corporation announced a limited U.S. launch of its Precision Spectra spinal cord stimulation device, which received FDA approval following CE Mark approval. International Neuromodulation Society past president Giancarlo Barolat, M.D., medical director of Barolat Neuroscience in Denver, called the device "a paradigm shift". It uses a proprietary computer model, Illumina 3D, to guide control of the stimulation field based on 3D anatomy and the conductivity of the spinal cord and surrounding tissue. (Yahoo Finance)
Peripheral Nerve Stimulation Trial for Back Pain Begins Enrolling Patients
April 11, 2013 - Patient enrollment has begun in the SubQStim II pivotal clinical trial of peripheral nerve stimulation for chronic back pain. Medtronic, Inc. plans for up to 323 patients at up to 30 U.S. centers in the trial, in which patients will be randomized into control or treatment groups for the first three months, then participate in open-label follow-up for up to five years. (Mass Device)
Company Announces Research Funding, Prize to Develop "Electroceuticals"
April 10, 2013 - The global pharmaceutical company GlaxoSmithKline (GSK) announced plans to foster development of "electroceuticals" that were compared to a cross between a device and molecular medicine. The investment might initially target using an electric stimulus to regulate cytokine production involved in inflammatory diseases such as rheumatoid arthritis. The unveiling includes a $1 million research prize, and initial funding of work by 40 scientists in 20 labs at such institutions as MIT, the University of Pennsylvania, and Feinstein Institute of Medical Research. Heading the effort, GSK Vice President of Bioelectronics Research and Development Kristoffer Famm was lead co-author of a commentary in Nature. (Fierce Biotech)
Future Growth Will be a Key Topic of the INS 11th World Congress Pre-Conference, Innovations in Neuromodulation
April 10, 2013 - The International Neuromodulation Society expects more than 200 entrepreneurs, thought leaders, innovators and investors at Innovations in Neuromodulation on June 9th in Berlin, a pre-conference of the INS 11th World Congress. The day-long session draws industry strategists and investment managers by focusing on business, technical, and regulatory developments in this rapidly changing field. (BusinessWire)
Regulatory Agency Issues First Approval for Deep Brain Stimulation for Both Primary and Secondary Dystonia
April 10, 2013 - St. Jude Medical, Inc. announced it is the first to receive CE Mark approval for use of deep brain stimulation to manage both primary and secondary dystonia. Dystonia is considered secondary when its cause can be attributed to a toxin, injury, or another disease or condition. In the announcement, International Neuromodulation Society Member Elena Moro, Ph.D., professor of neurology at the University Hospital Center of Grenoble, France noted that the involuntary muscle contraction and spasms of dystonia strike people of all ages. (St. Jude Medical)
Neuromodulation Market Report Offers Forecast to 2017
March 25, 2013 - Research and Markets calls neuromodulation a high-growth industry for the next decade, and offers the report "Neuromodulation Market - [Spinal Cord Stimulation (SCS), Vagus Nerve Stimulation (VNS), Gastric Electrical Stimulation (GES), Deep Brain Stimulation (DBS), Sacral Nerve Stimulation (SNS), & Transcranial Magnetic Stimulation (TMS)] - Forecasts to 2017". (PR Newswire)
Maker of High-Frequency Stimulation Device Garners $48 Million in Series C Financing
March 7, 2013 - Nevro Corp. has completed a $48 million Series C round of financing led by new investor Novo Ventures, with New Enterprise Associates and Coviden Ventures. Existing investors participating in this financing round included Accuitive Medical Ventures, Bay City Capital, Johnson & Johnson Development Corporation, Mayo Clinic, MPM Capital, and Three Arch Partners. Based in Menlo Park, Calif., Nevro is commercializing the Senza® high-frequency spinal cord stimulation system for chronic pain, such as low back pain, and other conditions. The system is available in Europe and Australia. The funds will be used to sponsor an ongoing U.S. clinical trial, explore new indications, and support commercialization. (Nevro)
Neuromodulation Market Report Predicts $12.45 Billion Market by 2023
March 4, 2013 - In a market report that spans 2013 - 2023, Visiongain projects a value of $12.45B for the global neuromodulation devices market in 2023. Among other factors, the report describes expanding disease indications. (PR Newswire)
Heart Failure Neuromodulation Developer Receives Additional Startup Funding
Feb. 28, 2013 - Sorin Group announced a $5 million investment in Israel-based Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure. Sorin Group, a global medical device company based in Milan, has invested in Enopace in 2011 and anticipates further investments based upon completion of development milestones. (BusinessWire)
Device Supplier Posts Strong Profits in Fourth Quarter
Feb. 26, 2013 - Greatbatch, Inc. posted a fourth-quarter 2012 adjusted earnings per share of 53 cents significantly exceeded the year-ago adjusted earnings of 39 cents (up 36% year over year). Within the neuromodulation and cardiac rhythm management area, sales decreased 5% year over year to $73.7 million due to market competition, strong shipments in the prior quarter and tough year-over-year comparables. In this sector, management anticipated short-term headwinds from key original equipment manufacturer customers. (NASDAQ.com)
Deep Brain Stimulation Developer Receives Additional Funding
Feb. 25, 2013 - Sapiens Steering Brain Stimulation B.V. of Eindhoven, the Netherlands and Munich, Germany, has added €7.5 m to its €16.5 m round of Series A financing. The investment supports development of a deep brain stimulation with the capacity to steer the electrical pulses away from areas which may produce side-effects. The most recent financing comes from the Dutch investment group INKEF Capital, whose founder Frank R. Landsberger, PhD, was appointed to the company's advisory board. Sapiens was spun out in 2011 from Royal Philips Electronics to commercialize a steering brain stimulation probe, implant and image-guided programming. (News-Medical.Net)
Vagus Nerve Stimulation Device Company Sees Shares Climb
Feb. 22, 2013 - Cyberonics Inc. said Friday that its net income climbed 39 percent in the fiscal third quarter as it sold more of its nerve stimulation devices designed to treat epilepsy and depression by delivering electrical stimulation to the vagus nerve. Net income in the November-January quarter rose to $13.2 million, or 47 cents per share, from $9.5 million, or 34 cents per share. Revenue rose grew 15 percent, to $62.7 million from $54.5 million. (CNBC)
Agreement Reached to Distribute Neuromodulation Products in Japan
Feb. 20, 2013 - The Boston Scientific subsidiary Boston Scientific Japan K.K. has reached an agreement with Fukuda Denshi Co., Ltd. to market and sell the Boston Scientific Spinal Cord Precision Plus System and accessories throughout Japan. Fukuda Denshi will begin distributing Boston Scientific neuromodulation products April 1, 2013. (Boston Scientific)
Clinic Created to Streamline Process for Potential Deep Brain Stimulation Candidates
Feb. 20, 2013 - A new clinic aimed at streamlining the evaluation and approval process for the growing number of patients who are potential candidates for deep brain stimulation has opened at the Muhammad Ali Parkinson Center of the Barrow Neurological Institute. The process should now be completed in six weeks or less, rather than up to one year, and includes comprehensive treatment education. (PR Newswire)
New Rates for INS Pre-Conference Sessions
February 2013 - The pre-conference sessions on June 8 and 9 for the 11th World Congress, Technology Transforming Chronic Illness Management, are now $360.53 each day, or $600 for both days. Register for one or two pre-conference days and the main congress and receive a 10% discount on the pre-conference fee. (International Neuromodulation Society)
Brazilian Chapter of the International Neuromodulation Society Launches Website
February 2013 - The Brazilian chapter of the INS (Sociedade Brasileira Neuromodulação - SBNM) has published its website listing articles, conferences, and members and their specialties, which include interventional pain treatment, movement disorders, spasticity, and neurosurgery.
Australia, Colombia Approve Non-Invasive Vagus Nerve Stimulation for Primary Headache
Feb. 19, 2013 - New Jersey-based ElectroCore announced approval from Australia and Colombia for its non-invasive vagus nerve stimulation (nVNS) therapies for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache and hemicrania continua) and medication-overuse headache in adults. The GammaCore therapy is available in Australia with physician authorization, and is expected to be available in Colombia in the first half of 2013. (MarketWatch)
Magnetic Resonance Imaging Compatible Spinal Cord Stimulation Systems Released in Europe
Jan. 30, 2013 - Medtronic, Inc. released in Europe the first spinal cord stimulation systems for use in treating chronic back and/or leg pain that are designed for compatibility with full-body magnetic resonance imaging (MRI) scans under specific conditions. The devices recently received CE Mark approval. They include special leads that can withstand MRI scanning and a proprietary programming option, SureScan, which sets an appropriate mode for an MRI environment. International Neuromodulation Society member J.P. Van Buyten, MD, from the AZ Niklaas Hospital in Belgium, was quoted as calling the development an important advancement. (National Pain Report)
Retinal Implant Maker Eyes Raising More Capital
Jan. 29, 2013 - Second Sight Medical of Sylmar, Calif. registered with the Securities and Exchange Commission on Monday to raise $25 million while waiting for the FDA to decide whether to approve its retinal implant, Argus II, which has been sold in Europe since 2011. (MassDevice)
Chronic Pain is Called a Poorly Recognized Silent Epidemic
Jan. 29, 2013 - International Neuromodulation Society president Simon Thomson, MBBS, FRCA, FIPP, FFPMRCA, commented in conjunction with release of a survey of more than 1,000 chronic pain sufferers across Europe, "The Painful Truth Survey: The State of Pain Management in Europe," sponsored by Boston Scientific and supported by a number of regional pain associations. He noted that healthcare systems throughout the world have not really produced specific answers to the needs of patients who suffer chronic pain that is not resolved by addressing any identifiable underlying condition. Some 17% of Europeans, he continued, will have significant chronic pain affecting daily living, with about 1/3 of those having pain that is really quite severe. About half suffer from neuropathic pain that arises spontaneously from damage to the nervous system. Of the patients whose neuropathic pain does not respond to pharmacological treatment, he said, spinal cord stimulation becomes an option, and has been advancing technologically since he first began using it slightly more than 20 years ago. (Boston Scientific)
Global Randomized Clinical Trial to Compare Medical Management With Or Without Spinal Cord Stimulation for Lower Back Pain
Jan. 28, 2013 - International Neuromodulation Society member Philippe Rigoard, M.D., is principal investigator of a global randomized clinical trial of patients with predominant low back pain due to failed back surgery syndrome. The study, sponsored by Medtronic, Inc., compares optimal medical management combined with use of a multicolumn, implantable lead for neurostimulation treatment and optimal medical management alone. The first of up to 300 patients in the PROMISE trial began treatment in the U.S. earlier this month, and Dr. Rigoard started enrolling patients January 14 at Poitiers University Hospital in France. The study is designed to assess the value of spinal cord stimulation (SCS) for predominant low back pain with leg pain. Previous studies focused on predominant leg pain. Health care utilization data will be collected to develop cost analysis models to potentially evaluate the long-term economic impact of SCS. (Yahoo Finance)
INS Website's List of Terminology Descriptions Grows
Jan. 24, 2013 - The latest addition to the International Neuromodulation Society's list of descriptions of terminology for use by patients or the general public is a brief overview about neuromodulation therapy. Since its inception one year ago -- through the efforts of the website's editorial contributors, the list of short explanations for treatment and condition terms has been viewed some 30,000 times by INS website visitors. (International Neuromodulation Society)
Neuromodulation Startup Adds Board Member
Jan. 22, 2013 - Functional Neuromodulation, founded in Toronto in 2010, has added Vince Owens, former CEO and director of Intelect Medical, to its board of directors. Other board members are company co-founder and CEO Dan O’Connell; founding scientist Andres Lozano, MD, PhD; Kelly Holman, managing director of Genesys Capital; and Andrew D. Firlik, MD, managing partner at Foundation Medical Partners. Lothar Krinke, PhD, vice president and general manager of Medtronic’s Deep Brain Stimulation business serves as an active board observer. Dedicated to applying deep brain stimulation (DBS) to memory and other cognitive disorders, the company is conducting the ADvance Study in North America to evaluate DBS of the fornix, a major pathway in the brain’s memory circuit, for patients with mild Alzheimer’s disease. (BioSpace)
Brain Scan Study of Parkinson's Patients Shows Impact of Subthalamic Nucleus Stimulation During Exercise
Jan. 22, 2013 - A positron-emission study of 12 Parkinson's disease patients at Hamamatsu University School of Medicine in Japan, published in the Journal of Cerebral Blood Flow and Metabolism, suggests beneficial effects of subthalamic nucleus stimulation in patients with Parkinson's disease are partly down to compensatory activation of non-motor dopamine pathways during exercise. (medwireNews)
Small-Business Grant Announced to Aid Deep Brain Stimulation System Programming for Parkinson's Disease
Jan. 22, 2013 - The National Institutes of Health, National Institute of Neurological Disorders and Stroke is funding a clinical feasibility study at the University of Alabama at Birmingham through a $283,828 Phase I Small Business Innovation Research grant to Cleveland, OH-based Great Lakes NeuroTechnologies to explore using intelligent algorithms to aid programming deep brain stimulation in Parkinson’s disease. The system will leverage existing technology to quantify Parkinson’s motor symptoms such as tremor, bradykinesia, and dyskinesia into a functional map. Intelligent algorithms will determine optimal parameters for symptom relief while minimizing side effects and battery consumption. (News-Medical.Net)
Functional Neuromodulation System for Foot Drop Cleared for Use by Minors
Jan. 22, 2013 - Valencia, Calif.-based Bioness Inc. announced it has received FDA clearance to market to pediatric patients and their caregivers its L300 system to treat foot drop, a condition which causes walking difficulty in adults and children who have motor-impairment conditions such as cerebral palsy, stroke or traumatic brain injury. The system consists of a small wireless sensor in the shoe, a sport brace-like leg cuff worn just below the knee, and a hand-held remote control. In addition to being used to assist walking, it can also be used for rehabilitation purposes. (Business Wire)
Israel-Based Company Eyes an Expanded Presence in U.S. Trading and Distribution
Jan. 21, 2013 - Brainsway Inc. of Israel expects to name a U.S. partner this quarter to distribute its noninvasive transcranial magnetic stimulation system for treatment-resistant depression, a technology it licensed from the National Institutes of Health. This step would precede seeking listing on the Nasdaq exchange, according to an article in Bloomberg BusinessWeek. (Bloomberg)
Analysis Estimates a $6.8 Billion Market for Neuromodulation in 2017
Jan. 14, 2013 - The U.S.-based firm Marketsandmarkets forecasts the global neuromodulation market will reach $6.8 billion by 2017. Vagus nerve stimulation is expected to see the most growth due to being less invasive and with more development of applications anticipated. The key factors that drive the neuromodulation market are higher incidences of endemic diseases, rise in aging population, technological advancement, devices under approval, and presence of several niche players. Reimbursement in certain geographies and cost of devices are major challenges. North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China. (PR Newswire)
New Device Rules Reported to Take Effect This Month in Russia
Jan. 11, 2013 - Revised regulations regarding medical device clearances in Russia reportedly took effect Jan. 1, 2013. It was previously reported that some of the anticipated changes were that final approval decisions will be made by “expert reviewers” rather than the regulator (Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation, or Roszdravnadzor); there was an apparent lack of timelines for medical testing, meaning they could last for years; and medical device registration fees would be written into law. One anticipated change could mean expert reviewers would determine whether additional clinical testing of a device is necessary and provide a list of hospitals where that should occur. A registration certificate would be issued to an applicant based on a positive expert review, or a refusal would be based on a negative expert review. (Mass Device)
Israel Company Announces Its Noninvasive Depression Treatment Device is Cleared by FDA
Jan. 9, 2013 - Brainsway Ltd. announced it has obtained FDA approval for its deep transcranial magnetic stimulation device to treat depression in patients who fail to respond to therapeutics during a depression cycle. (Globes)
Neuromodulation, Emerging Markets, May Contribute to Device-Maker's Bottom LineJan. 8, 2013 - Medtronic expects stronger performance in areas like neuromodulation to lift overall corporate growth. In comments Monday at the J.P. Morgan Healthcare Conference, Chief Executive Omar Ishrak also said that the countries outside of China, such as India in particular, but also Central Europe, Middle East and Africa, Latin America, all would be expected to be big growth engines. (Fox Business)
Smart Phone Interface Technology Presented for Controlling TENSJan. 9, 2013 - The Consumer Electronics Show included what was presented as a certified transcutaneous electrical nerve stimulation medical product by China-based E-Tek that uses an iPhone interface, according to a blog covering the event. (9to5Mac) External Peripheral Nerve Stimulator to Initially Target Post-Stroke Shoulder PainJan. 8, 2013 - SPR Therapeutics expects CE mark certification for its Smartpatch peripheral nerve stimulator to be announced shortly, according to published comments by the chief executive officer of the Cleveland-based company. Also, the company plans clinical trials at six U.S. centers in the next few months, initially targeting post-stroke shoulder pain. Finally, the company was reported to have raised an additional $2.8 million in financing, bringing the total to $5 million from NDI Healthcare Fund, Public Square Partners and individual investors. (MedCity News) Market Study Projects Neuromodulation Growth to $12.45 billion by 2023Jan. 8, 2013 - London-based Visiongain predicts a $12.45 billion global market for neuromodulation devices by 2023, with sales of $3.03 billion in 2011. Hemant Mistry, healthcare industry analyst, says, "The neuromodulation device market has experienced substantial growth in recent years, as their benefits in cost saving particularly have become more evident. Such devices can not only provide long-term relief to patients, but can also offer an effective alternative to the use of drugs that are well-known to have side effects . . . (although the initial cost of the device and surgery to implant the device is high, their prescription is cost-effective in the long-term). With future developments in the pipeline such as phrenic nerve and gastric stimulators . . . the market for neuromodulation devices has significant potential to grow in the future". (PR Newswire)
Financing Proceeds for Company Eying U.S. Trial to Treat Gastroesophageal RefluxJan. 3, 2013 - EndoStim Inc. of St. Louis, Mo. is reportedly two-thirds of its way through a round of raising $12 million in financing. The company has CE mark approval for its implantable electrical stimulation device that is designed to strengthen the lower esophageal sphincter muscle in cases of severe acid reflux. Following its European approval in August, the company is preparing for a U.S. clinical trial, which may start in late 2013. The company is reportedly planning to also develop neurostimulation devices to treat urinary incontinence and sexual dysfunction. (MedCity News)
Upcoming Neuromodulation Market Report Predicts Continued GrowthJan. 3, 2013 - The growth in emerging markets such as India and China will be driven by an aging population that will increase demand for newer treatment options for age-related diseases, such as deep brain stimulation (DBS) for motor disorders, according to a market report being published next month by Visiongain. The report, for instance, anticipates the DBS market will almost double in value, reaching $0.85 billion in 2017, with a compound annual growth rate of 11.2%. (Visiongain)
Company's Device Reaches 100,000th ImplantDec. 24, 2012 - Cyberonics, Inc. announced the 100,000th patient implant of its vagus nerve stimulation (VNS) system for epilepsy. This is the 15th year of VNS approval for the treatment of epilepsy in the U.S. and 25th anniversary of Cyberonics' founding. (NASDAQ)
Neuromodulation Market Report ReleasedDec. 5, 2012 - Reportlinker.com announced a new analysis of global neurostimulation markets from 2010 - 2018. The report analyses markets for spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electric stimulation; and profiles 21 companies, including Boston Scientific Corp., Cyberonics, Inc., Medtronic, Inc., St. Jude Medical, Inc., Synapse Biomedical, Inc., and SPR Therapeutics, LLC. (The Street)
Nov. 30, 2012 - Cyberonics, Inc. maintained an "outperform" rating by Zacks Equity Research due to strong continued growth in its vagus nerve stimulation products to treat epilepsy in the U.S. and abroad. The last-reported quarter saw a 17% increase in sales to $63 million compared to the same quarter last year, and an increase in earnings per share of 37.5% to 44 cents. The results surpassed Zacks consensus estimates of $60 million in sales and 39 cents in earnings per share. (Zacks Equity Research)
Patent Issues for Method to Treat Obesity Through Sympathetic Nerve StimulationNov. 27, 2012 - The U.S. Patent Office issued a patent Nov. 27, 2012 assigned to Advanced Neuromodulation Systems, Inc. (now part of St. Jude Medical) for treating obesity by electrically stimulating the sympathetic nervous system to induce feelings of satiety and increase energy expenditure. Stimulation would be applied on or near sympathetic nerves such as the sympathetic chain ganglia, the splanchnic nerves (greater, lesser, least), or the peripheral ganglia (e.g., celiac, mesenteric). (Equities.com)
Insurance Coverage for Overactive Bladder Neurostimulation Treatment ExpandsNov. 27, 2012 - More than 4 million insureds in California and Florida now have coverage for posterior tibial nerve stimulation (PTNS) for the treatment of overactive bladder, the device company Uroplasty, Inc. announced. In addition, Medicare administrators for 13 states have extended coverage from 1 to 2 years based on recent data showing sustained benefit from continued PTNS therapy. (Market Watch)
Patent Issued to Improve Reliability of Neuromodulation Lead ConnectionNov. 6, 2012 - A U.S. patent issued Nov. 6, 2012 and assigned to Medtronic, Inc. covers an implantable lead with coplanar contract coupling to reduce conductor bending moments where the contact connects to the lead, reducing chances of stress affecting the conductor that can interfere with reliability of the connection. (NewsRx.com) Patent Issued to Limit Patient-Initiated NeurostimulationNov. 6, 2012 - A U.S. patent issued Nov. 6, 2012 and assigned to Cyberonics, Inc. would provide the capability to set a variety of limits or alternative modes, which may include reduced repeat on-demand dosing, on patient-initiated stimulation doses for an implantable neurostimulator, such as a vagus nerve stimulator used to treat epilepsy. (equities.com)
Company Acquires Vagus Nerve Stimulation Developer to Enhance Heart Failure PortfolioNov. 12, 2012 - Milan-based Sorin Group announced acquisition of Neurotech SA, of Belgium, which developed an implantable vagus nerve stimulator that uses a rechargeable battery and records neural activity of the target. Sorin said the acquisition will accelerate the time to market of its neuromodulation therapies to treat heart failure. Neurotech SA was spun out of the Université catholique de Louvain with funding by SOPARTEC, the technology transfer company of Université catholique de Louvain, Vives Louvain Technology Fund SA and SRIW Techno SA (Société Régionale d'Investissement de Wallonie). (Business Wire)
Neuromodulation Market Predicted to Grow to More Than $7 billion by 2018Oct. 30, 2012 - The market for neuromodulation devices is expected to grow at a compound annual growth rate of 14.4 percent from 2012, reaching $7.07 billion in 2018, according to a report by Transparency Market Research. North America accounted for 65% of the market in 2011, while the Asia-Pacific region represents the fastest growth at a compound annual growth rate of 14%. Contributing to that growth is the aging population, coupled with the increase in chronic diseases, increasing demand for minimally invasive surgeries, and availability of external funding to conduct clinical studies to help come up with new and technologically advanced products. (PR Newswire)
Cleveland-Based Firm Receives Most Promising Startup AwardOct. 29, 2012 - Cleveland-based Neuros Medical, Inc. received Neurotech Reports' 2012 Gold Electrode Award for Most Promising Startup at the Neurotech Leaders Forum in San Francisco on Oct. 22. Publisher James Cavuoto said the company has a strong, focused market and is executing development of its technology in a sound and effective manner. The company is carrying out a pilot clinical trial to evaluate its patented high-frequency Electrical Nerve Block™ technology for acute treatment of pain in the residual limb of amputees. The company has also identified potential applications in chronic post-surgical pain, chronic migraine, and trigeminal neuralgia. (Neuros Medical)
Supplier Reports Increased Income from NeuromodulationOct. 26, 2012 - Greatbatch, Inc.'s neuromodulation and cardiac rhythm management sales increased 13% from the previous year, to $80.3 million, the company reported in a quarterly earnings statement. Overall, third-quarter adjusted earnings of 46 cents per share exceeded the year-ago adjusted earnings of 41 cents per share and were above an analyst consensus estimate of 44 cents per share. The company reported a net loss of $7.6 million, compared to a net gain in the third quarter of 2011 of $7 million. The cause of the loss was reported to come from operational hazards at its Swiss orthopedic facilities.
Low-Profile Neurostimulation Device Earns PatentOct. 25, 2012 - International Neuromodulation Society member Carl Wahlstrand and Robert Skime are inventors on a U.S. patent issued Oct. 23, 2012, and assigned to Medtronic, Inc. for a neurostimulation device with a low profile so it may be implanted directly beside a neuralgic region at the back of the neck, for instance, to relieve symptoms of occipital neuralgia. (equities.com)
Paralympic Athlete Releases Her Biography Next Week at Neurotechnology Conference Oct. 15, 2012 - Jennifer French, a quadriplegic and competitive sailing athlete who recently medaled at the 2012 Paralympics Games in London , will release her new book, On My Feet Again: My Journey Out of the Wheelchair Using Neurotechnology, October 23, 2012 at the Neurotech Leaders Forum in San Francisco. She uses a functional electrical stimulation (FES) system that was designed and developed at the Cleveland FES Center, a consortium of Case Western Reserve University, Veterans Administration and MetroHealth Medical Center. (Neurotech Reports)
Market Research Report Examines Neuromodulation Devices Forecast through 2018Oct. 17, 2012 - Transparency Market Research offers a report on the neuromodulation devices market, including global industry size, market share, trends, analysis, and forecasts from 2012 - 2018. The announcement lists major device companies as including Medtronic, St. Jude Medical, Boston Scientific, Cyberonics, IntraPace, Nevro, Johnson & Johnson, Codman, and Integra. (SBWire)
Patent Issued for Powering Medical Implants Passively from an External SourceOct. 11, 2012 - Medtronic has received a new U.S. patent for a passive method of powering implanted medical devices wirelessly from an external source, including possibly having the source be located in chairs, blankets or clothing. (MassDevice) China, India Launch New Medical Regulatory GuidelinesOct. 9, 2012 - China's State Food & Drug Administration released instructions that will require Chinese labels or packaging marks on foreign medical devices as of April 1, 2013. Meanwhile, India's Drug Controller General of India has begun a special effort scrutinizing manufacturing processes for discrepancies, and is considering introducing a bill this winter on drugs, cosmetics and medical devices, due to a growing consensus that a separate governing law is needed for medical devices. (HealthpointCapital)
Market Report Predicts the Neuromodulation Market Size May Rival That of Cardiac DevicesOctober 2012 - A new market report segments the neuromodulation sphere into deep brain stimulation, transcranial magnetic stimulation, spinal cord stimulation, vagus nerve stimulation and peripheral nerve stimulation. It claims the market from 2012-2018 will benefit from growing demand for non-invasive treatment options and by addressing large patient populations in epilepsy, anxiety disorders, stroke, depression, Parkinson's disease and others. Overall, it predicts the neuromodulation market to become as big as the cardiac devices market. (Transparency Market Research)
Israeli Exoskeleton Maker Plans a U.S. Headquarters in MassachusettsOct. 2, 2012 - Argo Medical Technologies Ltd. announced it will open U.S. headquarters in Marlborough, Mass, as part of its entry into the U.S. market for its exoskeleton that allows paraplegics to walk. The ReWalk device is currently available for use at rehabilitation centers by multiple users, according to news reports. CE Mark approval was received in 2010 for the Israel company's system. (Boston.com) Hand Prosthesis Maker Creates Version Appropriate for Smaller and Younger AmputeesOct. 1, 2012 - Touch Bionics of Livingston, Scotland, has announced release of a compact version of its hand prosthesis that includes individual artificial fingers whose action is powered by batteries in a wristband. This version allows the i-Limb Digit to be fitted to smaller persons, as well as young teen-agers or possibly younger people, the company said. (The Scotsman)
Article Predicts Neuromodulation Will Be Better-Known by the End of the DecadeOct. 1, 2012 - Increasing popular interest and technological development are two of the factors driving neuromodulation market growth, according to a synopsis in an online trade publication. (Neurogadget.com) News Feature Article Explores Neurostimulator Company's Status and Market ProspectsOct. 1, 2012 - Cyberonics' vagus nerve stimulators have been implanted in 55,000 U.S. patients with treatment-resistant depression since 1997; business in Europe is growing in double digits, and approval was received in Japan for the treatment of refractory epilepsy two years ago, where about 350,000 potential patients have treatment-resistant epilepsy. The $24,500 device's generator is about 3/4 of the total cost, and must be periodically replaced. Possible future markets may include depression and chronic heart failure. (Investor's Business Daily)
Analyst Firm Forecasts a $6.9 Billion Market by 2018, Examines Driving FactorsSept. 28, 2012 - Global Industry Analysts, Inc. reports the release of its comprehensive global report on neurostimulation markets. The firm identified more than 140 products in the development pipeline, and vagus nerve stimulation seems to be the fastest-growing intervention, at a projected 23%. The market is anticipated to reach $6.9 billion by 2018. (PR Web) Minneapolis Back-Pain Neuromodulation Therapy Start-Up Secures $20 Million, Will Move to IrelandSept. 27, 2012 - Mainstay Medical, which targets chronic non-specific lower back pain, has obtained $20 million in financing and will relocate to Ireland from Minneapolis. Chief Executive Peter Crosby, a member of the International Neuromodulation Society, is quoted as saying the therapy is based on recent science, and that one societal benefit of improved therapy is returning people to work. (Irish Times)
Insurance Group in New England Will Cover Overactive Bladder Neuromodulation TreatmentSept. 26, 2012 - ConnectiCare of the Emblem Health family of insurers has begun coverage of percutaneous tibial nerve stimulation (PTNS) using Uroplasty Inc.'s Urgent PC system for overactive bladder. With the insurance coverage, the therapy is available to 240,000 ConnectiCare members. Also, the California Technology Assessment Forum has concluded that PTNS meets short-term benefit criteria. (PR Newswire)
Company to Present External Trigeminal Nerve Stimulation System at London Epileptology MeetingSept. 25, 2012 - At the 10th European Congress on Epileptology in London, NeuroSigma, Inc.'s external trigeminal nerve stimulation (TNS) system, Monarch eTNS, will be subject to a symposium Sept. 30 on TNS for epilepsy and neuropsychiatric disorders. Among the presenters will be International Neuromodulation Society member Ian Cook, MD, NeuroSigma senior medical advisor and professor of psychiatry at the University of California, Los Angeles. (Sacramento Bee)
Sept. 20, 2012 - St. Jude Medical Inc. has received CE Mark approval for its Eon family of neurostimulators for patients with intractable chronic migraine. The company previously received CE Mark approval for European marketing of the industry's first-approved implanted neurostimulation device for this indication, the Genesis system. The new approvals include the rechargeable Eon mini and Eon systems and EonC (a non-chargeable option). (St. Jude Medical)
U.S. Firm Partners with German Company to Fund Trial of Vagus Nerve Stimulation in Epilepsy
Sept. 20, 2012 - Cyberonics, Inc. has invested EUR 2 million in cerbomed GmbH, becoming a minority shareholder and financing a current clinical trial in Germany of cerbomed's transcutaneous vagus nerve stimulation device, Nemos, for the treatment of epilepsy. Commercially available in Germany and Austria, the system received CE Mark approval for the treatment of epilepsy and depression in 20120, and pain in 2012. Houston-based Cyberonics developed and markets an FDA-approved vagus nerve stimulation system for the treatment of medically refractory epilepsy and treatment-resistant depression. Under the agreement, Cyberonics may invest up to EUR 5.5 million and optionally conduct a Nemos clinical trial in the U.S. (4-traders.com)
Supplier Eyes Expanding Global Markets for Deep Brain Stimulation Surgical Equipment
Sept. 18, 2012 - Greenville Neuromodulation Services, a subsidiary of FHC, Inc., hosted a tour of the Pennsylvania Department of Community and Economic Development following a trade mission to Saudia Arabia. The company has offices in Columbia, South Africa and Argentina, and is setting up an office in Brazil. (WKBN 27)
Global Implant Market Expected to Grow to $134.3 billion in 2017
Sept. 6, 2012 - A newly issued global bio-implants market forecast from 2012 to 2017 by Marketsandmarkets anticipates Asia will show a higher growth than the U.S. and Europe due to foreign investment and government funding there in a range of technologies, from neurostimulation to cardiovascular, orthopedics, and more. The report predicts the global market will grow from some $94 billion in 2012 to $134.3 billion in 2017. (PR Newswire)
External Trigeminal Nerve Stimulation System Receives CE Mark for Epilepsy, Depression
Sept. 5, 2012 - NeuroSigma, Inc. received CE Certification for its external trigeminal nerve stimulation system, Monarch, for the adjunctive treatment of epilepsy and major depressive disorder in adults and children 9 years old and older. The system is composed on an external pulse generator and disposable electric patches that are placed on the forehead and replaced daily, and can be worn primarily at night during sleep. International Neuromodulation Society member Leon Ekchian, PhD, the company's president and chief executive officer, said approvals are being sought to commence a multi-center trial of the therapy in epilepsy in the U.S. and Europe. (Sacramento Bee)
Company Says FDA Clearance Obtained for Urinary Incontinence Device
Aug. 30, 2012 - Colorado-based Zynex, Inc. announced FDA 510(k) clearance of its InWave medical device, primarily used for treating female urinary incontinence. The company manufactures and markets diagnostic and electrotherapy devices, and recently opened a European subsidiary. (Reuters)
Device Maker Announces Layoffs and Organizational Consolidation in Advance of Device Tax Taking Effect
Aug. 30, 2012 - St. Jude Medical, Inc. announced immediate layoffs of 300 of its approximately 16,000 employes and reorganization that places its neuromodulation and cardiac rhythm management divisions into an implantable electronic systems operating unit. Overall, its four divisions are being realigned into two operating units. The company said the moves are directed to lowering operating costs and analysts speculate the cost savings will equate to the expected medical device tax coming in the U.S. in 2013. (Minneapolis Star Tribune)
Vagus Nerve Stimulation Company Investors Anticipated to Seek Profits Following Positive First-Quarter Results
Aug. 28, 2012 - Cyberonics Inc. shares opened trading on Tuesday about 10% up after the company released first-quarter results that beat analyst expectations, then dropped to about 5% up near mid-day. Prices may decline slightly during the week as investors take profits, predicted the information service PropThink. The vagus nerve stimulation device company reported sales growth of 15% and income growth of 35% over the same quarter a year ago. (PropThink via Reuters)
Wireless Transcutaneous Electrical Nerve Stimulation Device Receives FDA Marketing Approval for Back Pain
Aug. 28, 2012 - The CNET blog "Crave" reported on the WiTouch wireless transcutantous electrical nerve stimulation device (TENS), recently cleared by the FDA for marketing for back pain in the U.S. In addition to this over-the-counter version, the device maker Hollywog of Chattanooga, TN, was also cleared to market the WiTouch Pro, a programmable version that can be used on the upper back and is available by prescription. (CNET)
Rechargeable Spinal Cord Stimulation System Receives CE Mark Approval for European Use in Peripheral Nerve Stimulation for Intractable Chronic Pain
Aug. 27, 2012 - International Neuromodulation Society member David Abejón, president of the INS Spanish chapter (Sociedad Española de Neuromodulación), was quoted about the apparent promise of peripheral nerve stimulation in a press release announcing that Boston Scientific Corp. received CE Mark approval for use of its rechargeable spinal cord stimulation device for peripheral nerve stimulation to treat patients with chronic, intractable pain of the trunk. (EIN World News Report)
Vagus Nerve Stimulation Company Due to Release Quarterly Earnings Report
Aug. 24, 2012 - Cyberonics, Inc., which markets a vagus nerve stimulation system, was reported to be expected to release results for the first quarter of fiscal 2013, with an anticipated earnings per share of 36 cents on revenues of $58 million for the quarter. (Zack's Investment Research)
Market Report Places Size of Neurostimulation Market at $16.3 billion in 2011
Aug. 17, 2012 - The "Markets for Electrostimulation Devices" report from notes that the neurostimulation market reached $16.3 billion in 2011 and has a moderate growth projection for the next few years. The report was recently issued by the life sciences research publisher Kalorama Information. (Healthcare Finance News)
Weight-Loss Neurostimulation Device Maker Seeks to Raise Additional Capital
Aug. 15, 2012 - EnteroMedics, a weight-loss neurostimulation device maker, filed regulatory documents with the U.S. Securities and Exchange Commission to sell up to $75 million in stock, securities and warrants. Through exercising warrants, the device maker may issue more than 1.7 shares of common stock. (MassDevice)
Market Report Analyzes Neurostimulation Trends
Aug. 10, 2012 - A recently released neurostimulation device market report covers Medtronic, Inc., St. Jude Medical, Inc., Boston Scientific Corporation and Cyberonics, Inc., and tracks the market size of five neurostimulation device market segments: cortical stimulators, deep brain stimulators, sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. (SBWire)
Business Publication Features Growth of Neurmodulation in the Cleveland Area
July 2012 - An article in Crain's Cleveland Business focuses on the growth of neuromodulation businesses in the Cleveland, Ohio area. (BioEnterprise)
Voiding Dysfunction Product Helps Boost Company's Revenue
July 26, 2012 - In Uroplasty Inc.'s first quarter of 2013, sales were up 40%, driven by a 64% increase in the sales of its Urgent PC Neuromodulation System to treat overactive bladder and related symptoms using percutaneous tibial nerve stimulation. (Market Watch)
New Ohio-Based Medical Commercialization Network Will Focus on Neuromodulation and Other Emerging Technologies
July 24, 2012 - In what is described as the creation of the largest medical commercialization network in Ohio, neuromodulation will be one of the first areas of innovation to be targeted for commercialization under a new regional partnership, the Cleveland Plain Dealer reported. International Neuromodulation Society member Ali Rezai, president of the INS North American Chapter and director of the Ohio State University's Center for Neuromodulation, was quoted about the new partnership between Ohio State University and the Cleveland Clinic. The development was also reported by MedCity News. (Plain Dealer)
Faculty Member Who Works to Optimize Deep Brain Stimulation to be Honored with Presidential Early Career Award for Scientists and Engineers
July 24, 2012 - An assistant professor of biomedical engineering who devotes her career to improving design and control of deep brain stimulation is among 96 researchers to be honored in a ceremony next week with a Presidential Early Career Award for Scientists and Engineers. Sridevi V. Sarma, a faculty member at Johns Hopkins University's Department of Biomedical Engineering, as also acknowledged for her mentioning of women in science and engineering. (Newswise)
Spinal Cord Stimulation Products are Addressed in Reports at Medical Conference
July 18, 2012 - International Neuromodulation Society member Stephen Pyles, MD, commented on an analysis that was awarded Best Poster at the 20th Annual Scientific Meeting of the International Spine Intervention Society, in which information from a database of more than 6,000 patients who were implanted with a Boston Scientific Precision Plus spinal cord stimulation (SCS) system showed that the group of patients who received the company's Clik Anchor system had more than 40 percent fewer revisions due to lead migration. Additionally, results were presented for 25 patients who underwent a SCS trial using the Infinion 16 Lead. Of those, 88 percent experienced significant pain relief and met criteria for a permanent implant. (Market Watch)
Quarterly Earnings Report Reflects Neuromodulation Growth
July 18, 2012 - In its second quarter earnings report, St. Jude Medical, Inc. reported that neuromodulation product sales were up 2 percent compared to the second quarter of 2011, to $106 million, and revenue increased 5 percent after adjusting for foreign currency. (Market Watch)
Company Announces Second Round of Financing
July 18, 2012 - Cleveland-based Neuros Medical announced it has raised $3.5 million in a second round of funding, led by Boston Scientific and Glengary LLC. Also joining in the round were current investors Case Tech Ventures, JumpStart Ventures, NorthCoast Angel Fund, Ohio Tech Angel Fund, Queen City Angel Fund III, Physician Investment Group, as well as new investors RiverVest Venture Partners, LLC, Blue Tree Allied Angels, and ModelVest. The company has begun a pilot clinical trial of a high-frequency Electrical Nerve Block™ technology to treat pain in the residual limb of amputees. (Neuros Medical)
Company Moves into Asia Pacific
July 17, 2012 - Greatbatch, Inc. will establish a research and development center in Singapore focused on active implantable devices. The company is moving from component manufacture to complete medical device systems and an Asia Pacific strategy. The company is developing a spinal cord stimulator, Algostim, to treat chronic pain in the trunk and limbs. (Market Watch)
Neuromodulation Product Pipeline Volume is Described
July 13, 2012 - Coverage of a market report by GBI Research indicates there are 144 products in the neurostimulation pipeline. Deep brain stimulators are reportedly the largest component, comprising almost 17%, then vagus nerve stimulators, with 21 pipeline products, and spinal cord stimulators have just seven products expected on the horizon. (NeuroNews)
Licensing Agreement Targets MRI-Compatible Leads for Vagus Nerve Stimulation System
June 11, 2012 - Cyberonics, Inc. has entered into an exclusive technology license agreement with Imricor Medical Systems, Inc. to develop magnetic resonance imaging-compatible leads for use with its vagus nerve stimulation system. (PR Newswire)
CE Mark Granted for Vagus Nerve Stimulator to Treat Refractory Epilepsy
June 8, 2012 - Belgium-based Neurotech has received CE mark approval for its vagus nerve stimulation system to treat epilepsy patients who are refractory to anti-epileptic drugs and not eligible for surgery. The company's ADNS-300 uses a cuff electrode to record vagus nerve activity, which can be used to personalize the treatment. (Medical Device Network)
Vagal Nerve Stimulation Device Company Reports Increased Earnings on Par with Estimates
June 6, 2012 - For the quarter that ended April 27, 2012, Cyberonics reported U.S. net sales increased 10% in the period, while international net sales grew 33%, on a constant currency basis. Net income and diluted earnings per share were both up, at $10.7 million and 38 cents per share respectively, compared to last year's $7.4 million and 26 cents diluted earnings per share. The company markets an FDA-approved vagus nerve stimulation (VNS) system for epilepsy and treatment-resistant depression, and said further growth is expected based on global replacement activity of VNS in epilepsy. The company repurchased $50 million in shares for the year, had $97 million in cash at the year's end, and met analysts' earnings estimates for the quarter. (Cyberonics)
Company Expected to Seek FDA Approval to Market Its Device to Treat Depression with Deep Transcranial Magnetic Stimulation
May 30, 2012 - Following a multicenter trial http://on.msnbc.com/LGskwE of deep transcranial magnetic stimulation in 233 patients suffering from treatment-resistant depression, Brainsway is expected to seek FDA approval to market its device in the U.S. in June. The initial trial results showed that after five weeks of treatment with the helmet-shaped device, some 30% of patients in the treatment group went into remission and 36.7% of patients showed more than 50% decrease in symptoms. The device delivers magnetic stimulation in a wider area of the brain than the more focused stimulation delivered by repetitive transcranial magnetic stimulation. (IEEE Spectrum)
Company Receives Commercialization Loan for Shoulder-Pain Device
May 24, 2012 - The Ohio Department of Development will loan SPR Therapeutics $900,000 to commercialize the company’s neurostimulation pain-relief system, designed to relieve post-stroke shoulder pain through peripheral nerve stimulation. (MedCity News)
Incontinence Device Maker Announces Plans for U.S. Pilot Study, and Implantable Device Development
May 24, 2012 - Uroplasty Inc. expects to spend $800,000 this fiscal year, through March 31, 2013, on a pilot study of percutaneous tibial nerve stimulation system for fecal incontinence in the U.S., as well as to develop an implantable tibial nerve stimulator for home-care incontinence treatment as an extension of the current office-based therapy. The development of an implantable device will start in Europe, where the device already has a CE Mark for treating fecal incontinence. (Uroplasty)
Neuromodulation Device Company Founder Honored for Professional Achievement by IEEE
May 23, 2012 - The retired founder of the company whose vagus nerve stimulation system achieved FDA approvals for certain forms of epilepsy and depression in 1997 and 2005, respectively, has been honored by receiving the 2012 Professional Career Achievement Award from the Institute of Electrical and Electronic Engineers (IEEE) Engineering in Medicine & Biology Society. Reese S. Terry, Jr., served twice as CEO of Cyberonics, as well as serving as a member of its board, and previously co-developed programmable heart pacemakers. (PR Newswire)
Device Maker Reports Revenue Growth in Fourth Quarter
May 22, 2012 - In its fiscal year ended April 27, 2012, Medtronic, Inc. reported overall revenue growth, including neuromodulation revenue of $463 million, up 8% on a constant currency basis. Growth was driven by an increase in new implants in pain stimulation, deep brain stimulation (DBS), and stimulation for urinary and bowel incontinence indications. Growth in pain stimulation was driven by launches of its RestoreSensor(R) spinal cord stimulator with AdaptiveStim(R) technology in the U.S. and Japan. Sales of DBS products were driven by an increased focus on neurologist referrals. (BusinessWire)
Device Component Supplier Will Move Corporate Headquarters to Texas
May 22, 2012 - Medical device supplier Greatbatch Inc. announced it will move its corporate headquarters from outside Buffalo, N.Y. to Frisco, Texas, to be near medical technology firms, academic research centers, and an international airport. The company will maintain offices, manufacturing and research and development operations in western New York. (Dallas News)
Bioness Inc. to Market Foot Drop System for More Sizes
May 15, 2012 - Bioness Inc. announced 510(k) clearance from the FDA to market a smaller leg cuff for use with its neuromodulation technology designed to treat foot drop, that causes difficulty walking for persons with motor deficits resulting from conditions such as stroke, multiple sclerosis, traumatic brain injury, spinal cord injury or cerebral palsy. The new cuff size provides access to the device for patients with smaller calf sizes. (Market Watch)
Sleep Apnea Device Company Receives Series C Financing, Completes Patient Enrollment
May 11, 2012 - Inspire Medical Systems, developer of neurostimulation therapies for the treatment of obstructive sleep apnea, has completed a Series C financing round of $14.5 million. Participating in this round of financing are new investors, Medtronic and TGap Ventures, and existing investors, including Kleiner Perkins Caufield & Byers, US Venture Partners, Synergy Life Science Partners and GDN Holdings. The company envisions filing a Pre-Market Approval application with the FDA in early 2013, based on a U.S. and European clinical trial, Stimulation Therapy for Apnea Reduction (STAR), for which patient recruitment and device implants have been completed. (MarketWatch)
April 26, 2012 - Novitas Solutions, the Medicare administrative contractor for approximately 4.6 million Medicare beneficiaries in Delaware, Maryland, New Jersey, Pennsylvania and the District of Columbia, will cover posterior tibial nerve stimulation (PTNS) services provided on or after April 9, 2012, based on a recent comparative effectiveness review entitled "Nonsurgical Treatments for Urinary Incontinence in Adult Women," published by the Agency for Healthcare Research and Quality (AHRQ), Uroplasty, Inc. announced in a press release. The company provides a minimally invasive PTNS treatment system, Urgent PC, for office-based treatment of overactive bladder and the associated symptoms of urgency, frequency and urge incontinence.(MarketWatch)
Greatbatch, Inc. Sees Sales Growth in First Quarter of 2012
April 26, 2012 - Neurostimulation component supplier Greatbatch, Inc. announced first-quarter 2012 results, including completed acquisition of NeuroNexus Technologies, which creates silicon-based electrodes and interconnects. Overall sales increased 7% to a record $159.1 million, although a lower gross profit, due to increased medical device investment and some production costs, was reflected in GAAP results and adjusted operating income. (MarketWatch)
Analyst Discusses Funding for Obesity Trial
April 20, 2012 - EnteroMedics' recent round of financing should allow it to complete its Recharge trial that examines its vagus nerve stimulation device in control and treatment groups, and probably also continue to a product launch, comments an analyst who follows the company. (MedCity News)
Small Business Receives Grants for Motor Symptom Monitoring and High School Curriculum
April 20, 2012 - Great Lakes NeuroTechnologies, which was spun out of Cleveland Medical Devices, has received a grant of about $3 million from the National Institute on Aging to enhance its technology that monitors Parkinson's disease symptoms at home, Kinesia HomeView. The platform uses a ring-like sensor worn on a finger to measure motor symptoms and transmit data about tremor. With the new funding, the platform will be enhanced to evaluate gait and balance. The company received an additional grant from the National Institute of Neurological Disorders and Stroke for a wireless physiological monitor and Web-based curriculum to teach neuroscience to high school students. (MedCity News)
Company Plans to Market a Transcutaneous Electrical Nerve Stimulator for Neuropathic Pain
April 18, 2012 - Massachussetts-based NeuroMetrix, Inc. has filed premarket notification with the FDA for its non-invasive transcutaneous electrical nerve stimulator, Sensus, intended to relieve and manage symptoms of chronic intractable pain, such as painful diabetic neuropathy. (MarketWatch)
St. Jude Medical Neuromodulation Sales Grow by 12 Percent
April 18, 2012 - In the first quarter of 2012, sales of neuromodulation products at St. Jude Medical, Inc. were $103 million, up 12 percent from the comparable quarter of 2011. (Seeking Alpha)
EnteroMedics Announces Additional Financing
April 17, 2012 - EnteroMedics, Inc., the Minnesota-based the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, announced it has amended its existing debt agreement with Silicon Valley Bank to obtain an immediate $10 million loan. The agreement includes a provision for an additional $10 million loan on completion of primary endpoints in its ReCharge study and other financial objectives for 2012. In addition, the company plans a registered direct equity offering valued at $5 million. The financing will retire an existing $4.7 million debt and support work toward regulatory approval of the Maestro Rechargeable System in the United States, international commercialization efforts, and other development and operating expenses. (Marketwire)
Deep Brain Stimulation Device Maker Closes Financing Round
April 10, 2012 - Aleva Neurotherapeutics, a company developing next-generation implants for deep brain stimulation, announced the closing of a Series B financing round totaling 4.0 million in Swiss francs. (Open PR.com)
Deep Brain Stimulation Device Maker Closes Financing Round
April 10, 2012 - Aleva Neurotherapeutics, a company developing next-generation implants for deep brain stimulation, announced the closing of a Series B financing round totaling 4.0 million in Swiss francs. (Open PR.com)
First Commercially Available Vagal Blocking Systems for Obesity Shipped to Australia
April 5, 2012 - EnteroMedics announced it has shipped its first commercially available MaestroRechargeable System for vagus nerve blocking therapy, VBLOC, designed to control both hunger and the feeling of fullness, to Australia. The company also said it has signed a multiyear distribution agreement to sell the system to countries in the Persian Gulf. (MedCity News)
Tissue-Securing System Now Permitted for Intrathecal Catheter Applications, Company Says
April 4, 2012 - Anulex Technologies announced it has received FDA approval to expand indications for its fiXate™ Tissue Band. The product was previously approved for securing Spinal Cord Stimulation (SCS) lead anchors to fascia or interspinous/supraspinous ligaments in patients with chronic, intractable pain of the trunk and/or limbs. The new indication allows for securing intrathecal pain pump catheters in the same tissue. (Enhanced Online News)
Early-stage Medical Device Company Announces New Vice President for Neurology
April 2, 2012 - NeuroSigma, an early-stage medical device company exploring new systems of trigeminal nerve stimulation for neurological disorders, has appointed its recent senior medical advisor, Christopher M. DeGiorgio, MD, to the new post of vice president, neurology. A professor of neurology at the University of California, Los Angeles, he was first to study TNS in patients with epilepsy, and collaborated with in developing TNS as a potential treatment for depression, PTSD and ADHD, the company said. (PR Newswire)
With an Approved Neurostimulation System for Overactive Bladder, is Small Company a Valuable Investment?
March 23, 2012 - Minnesota-based Uroplasty has had FDA clearance since 2005 for its system to treat urge incontinence, Urgent PC, which uses percutaneous tibial nerve stimulation. An investment column explores the market being pursued by this small company, and its stock's investment value. (Seeking Alpha)
How Mature is the Market for Transcranial Direct-Current Stimulation?
March 16, 2012 - A NeuroTech Zone blog looks at one company's intent to provide $99 mail-order devices for the non-invasive cortical stimulation approach transcranial direct-current stimulation. (NeuroTech Zone)
Neuromodulation Sales Increase in Medtronic's Third Quarter
February 21, 2012 - Medtronic's neuromodulation business reported a 4 percent increase to $419 million in the third quarter of a fiscal year ending April 30. The growth was driven by strong InterStim Therapy sales. Also, the company received FDA clearance in the third quarter for the RestoreSensor spinal cord stimulator with the proprietary AdaptiveStim technology. (Becker's Orthopedic, Spine & Pain Management)
Device-maker Greatbach Pays $12 million for Neural Interface Developer NeuroNexus February 17, 2012 - Reuters reports that Greatbach, a leading pulse-generator component maker, acquired NeuroNexus for about $12 million. NeuroNexus develops neural interface devices across a wide range of functions including neuromodulation, sensing, optical stimulation and targeted drug delivery applications. Key NeuroNexus technologies, high-density silicon-based electrodes and interconnects, are more suited to neuroprosthetic rather than neuromodulation therapies, points out NeuroTech Zone, adding that the acquisition "brings us one step closer to a long-awaited clinical trial of probes developed using the semiconductor microfabrication technologies." (NeuroTech Zone, Reuters)
St. Jude Fourth-Quarter Report Shows Neuromodulation Growth
February 3, 2012 - St. Jude's quarterly earnings report shows growth of the neuromodulation segment was up 12%. Overall revenues were up although that was offset somewhat by special charges. (Zack's)
Boston Scientific Announces CE Mark Approval and European Launch for Rechargeable Spinal Cord Stimulator InfinionTM 16 Percutaneous Lead
February 3, 2012 - At the World Institute of Pain Conference, Boston Scientific announced it has received regulatory approval to begin marketing its Infinion 16 Lead in European CE Mark countries. Already marketed in the U.S., it is designed for use with the company's rechargeable Precision PlusTM Spinal Cord Stimulator System. The first patient implant in Europe using the InfinionTM 16 Lead was performed at the Sahlgrenska University Hospital in Guldheden, Sweden by by Kliment Gatzinsky, MD, Ph.D., and David Revesz, MD - both members of the International Neuromodulation Society. (PR Newswire)
Hybrid Imaging and Emerging Markets are Growth Areas for Medical Devices
January 27, 2012 - The use of hybrid imaging technologies such as PET/CT and PET/MRI will see growth in the diagnostic imaging industry and will likely be a mainstay in future imaging, according to a report from GBI Research. The report also anticipates that the increasing demand for imaging in emerging markets, including China, India and Brazil, will balance the lower demand in developed countries, particularly the U.S., because of reimbursement cuts. (MolecularImaging.net)
Uroplasty, Inc. Reports 2011 Gains
January 26, 2012 - Uroplasty, Inc. notes in its quarterly report that the Medicare carrier for Florida has released a formal, specific reimbursement policy for posterior tibial nerve stimulation (PTNS) that becomes effective February 1. The device maker has the only FDA-cleared PTNS system for office-based treatment of overactive bladder and urge incontinence. Headquartered in Minnetonka, Minnesota, with subsidiaries in The Netherlands and the United Kingdom, the company reported its net operating losses are down, and global sales increased 53% to $5.3 million in the third quarter of fiscal 2012, compared with $3.5 million in the fiscal third quarter a year ago. Sales in the U.S. grew 78%, with an 89% increase in sales of the Urgent PC Neuromodulation System and a 71% increase in sales of Macroplastique. Outside the U.S., sales rose by 19%. (MarketWatch)
EnterioMedics, Inc. Receives Australian Approval for Vagal Stimulator Targeting Digestive Functions, Reports Ongoing Medical Trial Spending
January 26, 2012 - EnteroMedics Inc., which develops vagal neuroregulation devices to treat obesity, metabolic diseases and other gastrointestinal disorders by affecting the perception of hunger and fullness, announced final approval to commercialize its Maestro System in Australia. For the full year ended December 31, 2011, the company reported a net loss of $26.0 million, or $0.86 per share, and $29.7 million in cash and equivalents. Main operating expenses are for ongoing clinical trials, including the ReCharge Pivotal Trial, due to be unblinded by the end of 2012. In it, 233 patients are being evaluated at 10 sites to test effectiveness and safety of a second-generation Maestro System powered by a rechargeable integrated battery. All patients in the randomized, double-blind, parallel-group study are expected to participate in a weight management counseling program and receive an implanted device, with one-third of patients, in a control group, receiving a non-functional device for the duration of the study. (Newswire)
Cyberonics Announces FDA Approval of Re-Designed Generator for VNS Therapy
January 4, 2012 - Cyberonics issued a news release saying the FDA approved its re-designed AspireHC (High Capacity) generator for treatment-resistant epilepsy. The generator had been subject to a voluntary product withdrawal in August 2011, after the company learned that stimulation output current delivered to patients by the original units could be less than the output current programmed by a physician. (PR Newswire)
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