INS 11th World Congress in Berlin
Feb. 26, 2015 - Cyberonics, Inc. announced it has received CE mark approval of its vagus nerve stimulation for use as adjunctive therapy in treatment-resistant patients with heart failure with left ventricular dysfunction. The company's Vitaria system delivers autonomic regulation therapy, which was shown in the open-label ANTHEM-HF clinical study to improve a number of symptoms at six months of treatment. (Pharmabiz.com)
Feb. 26, 2015 - Cyberonics Inc. plans to merge with create a new company domiciled in the UK by buying* Italian medical device company Sorin SpA in an all-stock deal to create a new company with a combined equity of $2.7 billion. The new company will apply for dual-listing on the Nasdaq and the London Stock Exchange, the companies said in a statement. The newly formed company will include a portfolio addressing heart failure and sleep apnea, according to a news release by Sorin Group. *Note: Reuters later ran an updated story to clarify that this is a merger: http://www.reuters.com/article/2015/02/26/us-sorin-m-a-cyberonics-idUSKBN0LU0QE20150226 (Reuters)
Feb. 26, 2015 - The Rajiv Gandhi Government General Hospital in Chennai will begin offering deep brain stimulation when new equipment is procured in five months, with the services being covered under the Chief Minister’s Comprehensive Health Insurance Scheme. The government recently supplied the hospital a stereotactic capability, which has already allowed neurosurgeons there to perform brain-tumor biopsies more easily. (New India Express)
Feb. 25, 2015 - Second Sight Medical said the first implants of its Argus II Retinal Prosthesis System have taken place in France. Up to 35 patients with retinitis pigmentosa will receive the implants through the government reimbursement program Forfait Innovation. (Mass Device)
Feb. 25, 2015 - Greatbatch Inc. reported adjusted earnings per share of 65 cents in the fourth quarter of 2014, up 18.2% from one year ago. Revenues from QiG Group, which includes sales from the recently acquired implantable-pulse-generator-maker CCC Medical Devices, rose to $5.5 million from $0.9 million the previous year. (Nasdaq)
Feb. 24, 2015 - In a study at the Department of Urology, China Rehabilitation Research Center in Beijing, 100 patients with neurogenic detrusor overactivity secondary to spinal cord injury underwent a four-week randomized controlled trial that compared percutaneous tibial nerve stimulation (PTNS) with medical treatment with solifenacin succinate. Both treatment groups improved, with no significant difference between them. The author concludes that PTNS is effective, noninvasive, and easily managed by patients. (Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction)
Feb. 24, 2015 - Uroplasty, Inc. announced its percutaneous tibial nerve stimulation therapy for overactive bladder is now covered by Cigna, which wrote a positive coverage policy that applies to some 14 million people and became effective Feb. 15, 2015. (CNN Money)
Feb. 23, 2015 - Researchers at Prague's Charles University reported in the Proceedings of the National Academy of Sciences direct evidence of the emotional role of the subthalamic nucleus (STN). Patients undergoing deep brain stimulation (DBS) were shown visual images considered pleasant, unpleasant or neutral. Populations of neurons that were spatially and functionally separate responded either to the emotional valence (positive or negative) or the intensity of the emotional effect. A radio report said 17% of the STN neurons were involved in the response, and that more selective stimulation might improve DBS therapy. (Prague Daily Monitor)
February 2015 - The Foundation for the National Institutes of Health selected Karl Deisseroth, MD, PhD., for the 2015 Lurie Prize in Biomedical Sciences, to recognize his outstanding achievement, as a scientist under age 52, in the development of optogenetics and the brain-imaging tool CLARITY. The award, which began three years ago, will be presented in May in Washington, D.C. and includes a $100,000 honorarium. (Foundation for the National Institutes of Health)
Feb. 24, 2015 - Bioness, Inc. announced FDA clearance of its minimally invasive neuromodulation device for peripheral nerve pain, StimRouter®, which consists of an implanted lead, external pulse transmitter and conductive electrode, and is controlled by a small hand-held wireless control unit. Electrical signals travel from the pulse generator to the electrode and down the lead to the origin of pain. (Business Wire)
Feb. 23, 2015 - An earnings report for EnteroMedics, Inc., whose vagus nerve stimulation therapy for certain types of obesity received FDA approval in January, shows that as the company completed U.S. regulatory approval and geared up for commercialization, its losses totaled nearly $6.2 million in the fourth quarter of 2014. The loss of $0.09 per basic and diluted share was a slight improvement losses in the same quarter a year ago of $0.11 per basic/diluted share. For the year, EnteroMedics lost $26.1 million, and had $11.6 million on hand. (Mass Device)
February 2015 - International Neuromodulation Society (INS) member David Provenzano, MD presented results of a survey of infection-control practices for spinal cord stimulation procedures at the American Society of Regional Anesthesia and Pain Medicine's 13th annual pain medicine meeting in San Francisco in November. A summary of the e-poster now appears in Anesthesiology News. INS was among the societies where the survey had been circulated. (Anesthesiology News)
Feb. 23, 2015 - Saluda Medical announced it received $10 million in Series B financing in a funding round led by new investor Biosciences Managers, in which existing investors also participated. The Australian-based company plans to use the funds to support clinical trials and commercialization plans for its Evoke™ closed-loop spinal cord stimulation system that is intended to treat chronic pain of the trunk and limbs, automatically adjusting stimulation levels for optimal pain relief. (Send2Press Newswire)
Feb. 23, 2015 - Medtronic plc has acquired Advanced Uro-Solutions, a Tennessee-based developer of a percutaneous tibial nerve stimulation system, which consists of a small external stimulator and a single, reusable lead to provide temporary stimulation to the tibial nerve, NURO(TM). The device has FDA clearance for patients with overactive bladder and associated symptoms, and Medtronic plans U.S. commercialization within the next 12 months. (Fierce Medical Devices)
Feb. 17, 2015 - A column discusses the prospects of vagus nerve stimulation to treat inflammatory disease; in a related article, targets in the spleen, liver, and pelvic organs are presented as potential future applications of "bioelectric medicine". (Scientific American)
Feb. 20, 2015 - Five-year results of the SANTE (stimulation of the anterior nucleus of the thalamus in epilepsy) clinical trial showed an increase in efficacy over time of deep brain stimulation to treat adults with refractory epilepsy characterized by partial-onset seizures, according to a paper in Neurology. International Neuromodulation Society members Douglas Labar, MD, Jaimie Henderson, MD, and Ashwini Sharan, MD, were among the co-authors of the multi-center clinical trial report. SANTE (stimulation of the anterior nucleus of the thalamus in epilepsy) showed an increase in efficacy over time. The median rate of seizure reduction was 69%, compared to 41% at 12 months. Patients who seizures reduced in frequency by more than half, was 68% at 5 years, up from 43%. The rate of serious, but reversible, adverse events was 34% with infection at the implant site, at 10%, being the most common. The paper concluded that longterm followup indicated this intervention showed sustained efficacy and safety in a treatment-resistant population. (Fierce Medical Devices)
Feb. 19, 2015 - Helius Medical Technologies has enrolled the first three subjects in its multiple sclerosis feasibility study of a portable neurostimulation device, PoNS™, to reduce multiple sclerosis symptoms by stimulating the cranial nerves found in the tongue. In the double-blind, sham-controlled study, a total of 14 subjects will receive stimulation combined with physical therapy to improve balance and gait for 14 weeks at the Montreal Neurological Institute and Hospital and Concordia University’s PERFORM Center. (Business Wire)
February 2014 - International Neuromodulation Society members Timothy Deer, MD, Tim Lamer, MD, Robert Levy, MD, PhD, and Nagy Mekhail, MD, PhD, will present a preconference on neuromodulation prior to the American Academy of Pain Medicine meeting on March 18 in National Harbor, MD. The program will cover future targets and waveforms, clinician views of the best-practice recommendations, and discrepancies between current practices and the consensus recommendations. (American Academy of Pain Medicine)
Feb. 17, 2015 - AdvaStim, Inc. announced it received a U.S. patient for an integrated switching circuit and pulse generator for its neurostimulator lead. The company's technology is intended to provide compact multi-channel switching and electrode programming. (Business Wire)
Feb. 12, 2015 - Science correspondent Miles O'Brien, whose left arm was amputated after an injury last year, tried out a modular prosthetic limb that uses an array of electrodes to sense muscle firing in the stump and move the artificial limb. The limb is under development at the Johns Hopkins Applied Physics Laboratory with funding from the Defense Advanced Projects Research Agency. (PBS News Hour)
Feb. 16, 2015 - An article profiles a participant in a 19-patient study who found relief from cluster headaches through use of electroCore's external vagus nerve stimulator (VNS), gammaCore®. The article also touches upon other emerging uses of VNS therapy, such as appetite suppression to control obesity. (Daily Mail)
Feb. 14, 2015 - Researchers presented a clinical trial of auditory brainstem implants in pediatric patients at the annual meeting of the American Association for the Advancement of Science. Funded by the National Institutes of Health, the safety-and-feasibility study led by the Keck School of Medicine at the University of Southern California has enrolled five of 10 patients aged 2 - 5 years old who are not able to benefit from hearing aids or cochlear implants. After the device is implanted the children receive intensive speech-and-language therapy to learn to use and decipher speech. (domain-b.com)
Feb. 9, 2015 - NeuroNews published online an interview with four members of the International Neuromodulation Society board who were selected to speak as thought-leaders on neuromodulation "research priorities, challenges and potential areas for growth": Drs. Timothy Deer, Ali Rezai, Marc Russo, and Konstantin Slavin, (NeuroNews)
Feb. 11, 2015 - Milan-based Sorin Group announced the first successful vagus nerve stimulation (VNS) implants in the first clinical trial under its New Ventures organization that will explore a number of potential VNS therapies. The clinical trial of VNS in heart failure, Vanguard (Vagal Nerve Stimulation Safeguarding Heart Failure Patients), uses the he Equilia(TM) system initially developed by the Israeli startup Enopace Biomedical. (Business Wire)
Feb. 10, 2015 - Lahore General Hospital, which has begun offering deep brain stimulation (DBS) for Parkinson's disease and other movement disorders, announced at least six cases have been admitted to the hospital. A Parkinson's disease patient who was operated on there expressed gratitude for the government bearing the DBS expenses and was quoted as saying the facility is a great blessing for the poor. (The News International)
Feb. 10, 2015 - An article in a pain publication says the publication plans to cover spinal cord stimulation (SCS) more and quotes a recent market research study that says less than 10% of the people who might benefit from SCS for chronic pain use it. The report mentions Nevro Corp. as the new player in the market; its Senza SCS system received an "approvable" letter from the FDA. Meanwhile, the market research study by iData Research says Boston Scientific has grown market share and is a leading competitor in SCS for back pain and failed back surgery syndrome, while Medtronic still has the largest client base in SCS, and all three major players, including St. Jude Medical, have run public awareness campaigns. (National Pain Report)
Feb. 8, 2015 - A business feature profiles the Greenville Neuromodulation Center, which opened 10 years ago in Greenville, a borough of about 5,000 people, 80 miles from Pittsburgh and Cleveland, which is home to Thiel College. Eighteen months ago the center added a neurologist experienced in deep brain stimulation. (Sharon Herald)
Feb. 7, 2015 - The U.S. Department of Justice announced that Medtronic, Inc. agreed to pay $2.8 million to resolve allegations made by a former company sales representative, that the company caused some physicians to submit false reimbursement claims to federal health programs using a code for peripheral nerve stimulation when an investigational subcutaneous nerve field stimulation implant was performed. The settlement states that the "claims resolved by this settlement are allegations only, and there has been no determination of liability." (Sputnik News)
Feb. 6, 2015 - A pilot study of spinal cord stimulation in 17 heart-failure patients from Australia, Hong Kong, and Japan showed that 15 improved their composite score and 11 had improved efficacy parameters after six months, according to the Hong Kong-based investigators. (The Standard)
Feb. 4, 2015 - Nevro Corp. announced its Senza® spinal cord stimulation system has received approval for expanded labeling in Europe and Australia. The expanded labeling now permits scans of the head and extremities with both 1.5 and 3 Tesla MRI machines under specified conditions for existing and future patients. (Market Watch)
Feb. 4, 2015 - Microtransponder, Inc. plans a 20-person clinical trial in the U.S. of its Vivistim® System for stroke patients who are undergoing rehabilitation to improve upper limb mobility. On Feb. 12, its findings in a 20-person clinical trial in the United Kingdom will be presented at the International Stroke Conference in Nashville. The U.S. trial will take place in Dallas, Houston, and Minneapolis, and enrollment information is available at http://www.vnsstroketrial.com. (PR Web)
Feb. 3, 2015 - NeuroPace, Inc. published interim results of its long-term study of its responsive neurostimulation system in adults with medication-resistant epilepsy. The data from 230 adults show that after three years, the median seizure frequency reduced by 60%, and after six years, by 66%. (Business Wire)
Jan. 29, 2015 - A review in the European Journal of Neurology compares invasive and non-invasive vagus nerve stimulation (VNS), saying the non-invasive option "improves the safety and tolerability of VNS making it more accessible and facilitating further investigations across a wide range of uses when compared with surgically implanted VNS." (News-Medical.net)
Jan. 26, 2015 - Mainstay Medical International plc has applied for an FDA Investigational Device Exemption to begin a clinical trial of its ReActiv8® implantable neurostimulation device to treat people with disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated. (Mainstay Medical)
Jan. 23, 2015 - Medtronic announced a Humanitarian Device Exemption for its Enterra II neurostimulation implant for treating gastroparesis. (Mass Device)
Jan. 23, 2015 - A former biomedical engineer with Boston Scientific Corporation has created a small implanted device to stimulate nerves in the lacrimal gland to treat dry eye. After four years of work, the device is now a product-candidate undergoing clinical trials through the new company Occuleve. (Stanford Medicine)
Jan. 23, 2015 - According to the Modern Healthcare/ECRI Institute Technology Price Index, the average cost of spinal cord stimulators is now $16,957, up 8% from this time last year. The article mentions that advanced versions released in 2013 by Boston Scientific Corp. and Medtronic cost on average $19,000 while older models cost hospitals on average $13,000, although more hospitals are choosing to buy the newer devices. (Modern Healthcare)
Jan. 23, 2015 - MED-EL USA says it will launch its Synchrony cochlear implant in the U.S. following FDA approval for this model, which the company says is the only U.S.-approved one that can be used with 3.0 Tesla magnetic resonance imaging devices without surgical removal of the internal magnet. (FDA News)
Jan. 22, 2015 - Nevro Corp. announced the FDA has written to say that, subject to check-off on a number of inspection, audit, labeling, and similar compliance issues, its Senza spinal cord stimulation system is approvable under the premarket approval application, based on the application's supporting data. (PR Newswire)
Jan. 19, 2015 - Flownix Medical Inc. announced a PMA-Supplement approval from the FDA for is intrathecal Prometra® II system with a flow-activated safety valve that allows an MRI without the need to remove the drug from the reservoir in advance. (PR Newswire)
Jan. 21, 2015 - The International Neuromodulation Society 12th World Congress "Neuromodulation: Medicine Evolving Through Technology" will feature traditional and cutting-edge ways to address chronic disease through interfacing with the body’s nervous system, according to a news announcement. The event takes place June 6-11, 2015 in Montreal, Canada. (Newswise)
January 2015 - International Neuromodulation Society member Timothy Deer, MD, is quoted in an article about the Neuromodulation Appropriateness Consensus Committee guidelines that appeared in the August 2014 issue of Neuromodulation: Technology at the Neural Interface. (Anesthesiology News)
January 2015 - International Neuromodulation Society member David Provenzano, MD presented an international survey of infection-control practices during spinal cord stimulation implantation and trials. The survey was filled out by 506 respondents. In the presentation in a poster at the American Society of Regional Anesthesia and Pain Medicine 13th annual pain medicine meeting, the responses showed best practices and also areas for improvement, such as the responsibility for deep infection up to one year after implant, according to the Centers for Disease Control and Prevention definition. (Pain Medicine News)
January 20, 2015 - Ten patients with Parkinson's disease have undergone a test period of so called "noisy" electric stimulation of their balance organs (stochastic vestibular galvanic stimulation) to smooth out the effects of dopamine shortage and improve their motor skills and balance, after the concept was demonstrated in preclinical studies. The investigation in Sweden was published in the Journal Brain Stimulation. (Medical Express)
January 2015 - With volunteer effort, the collaborative neuromodulation literature database WIKISTIM is expanding to include deep brain stimulation citations as well as spinal cord stimulation citations, according to the January issue of the nonprofit organization's newsletter. (WIKISTIM)
Jan. 14, 2015 - EnteroMedics, Inc. received FDA approval for its vagus nerve stimulation therapy, VBLOC®, delivered through the Maestro® System. In an announcement, the FDA called it "the first FDA-approved obesity device since 2007," saying the device is approved for adults with a body mass index of 35 to 45 who have not been able to lose weight with a weight loss program and have at least one other obesity-related condition, such as type 2 diabetes. The approval requires a five-year post-market study of safety and effectiveness in 100 patients. (IEEE Spectrum)
Jan. 7, 2015 - Medtronic, Inc. said shareholders who have more than 75% of the stock voted in favor of its merger with Ireland-based Covidien, whose shareholders approved the deal hours earlier. The $43 billion merger should close in two weeks, turning Medtronic into an Irish-based entity, Medtronic PLC. (Mass Device)
Jan. 5, 2015 - NeuroSigma®, Inc. announced its external trigeminal nerve stimulation will be subject to a Phase II clinical trial of up to 90 children, aged 8-12, who have Attention-Deficit/Hyperactivity Disorder. The double-blind controlled trial will be supported by the U.S. National Institute of Mental Health (NIMH) and collect data on mechanism of action in alignment with the NIMH's Research Domain Criteria that emphasizes behavioral dimensions and neurobiological measures. The clinical trial will be carried out at the Semel Institute for Neuroscience and Human Behavior, located at the University of California, Los Angeles. (PR Newswire)
Jan. 4, 2015 - After a shareholder vote tomorrow on the $48 billion merger of Medtronic, Inc. and Covidien, an article in the Minneapolis Star Tribune says, Medtronic would become a new Irish-domiciled, multinational conglomerate called Medtronic PLC. Top executives will remain based in Fridley, MN. The New York Stock Exchange ticker will remain MDT, with the new shares expected to begin trading at the same price as the closing price from the day before. (Star Tribune)
To see select neuromodulation news by category, as well as news about the INS in particular, please visit the Newsroom. To see archived news briefs dating back to January 2011, visit the News Archive.
How Has Neuromodulation Been Developed and Used?
Conventional medicine has typically had four modes of treating diseases or disorders: counseling or “talk therapy”; physical therapy involving manipulation and strengthening of muscles and range of motion; pharmaceuticals that act on a chemical level; and altering or augmenting tissue through surgery, injections, or filtering methods like dialysis. The growing field of neuromodulation is a new class of therapies that involves directly treating the nervous system itself, often through small implanted devices that target a specific area, to rebalance the activity of neural circuits and manage symptoms.
Progress has been spurred by advances in our understanding of the nervous system, as well as new technologies and clinical experience, enabling treatments to modify nerve cell activity in brain, spinal cord and periphery to restore function, minimize pain, and treat disease symptoms. Developed over the last 45 years, neuromodulation has grown rapidly into a family of therapies that applies stimulation or agents directly to the nervous system, often using small implanted medical devices that are powered in a similar fashion to a cardiac pacemaker. By delivering electrical or chemical stimulation, neuromodulation has increasingly been used to treat motor disorders such as Parkinson’s disease, refractory chronic pain ranging from neuropathy to cancer related pain to severe headaches, spasticity, epilepsy, and incontinence. It is also under study for conditions ranging from gastroparesis to medically refractory depression. Providers of such therapies include neurosurgeons, pain physician specialists and rehabilitation physicians. They may often work with other specialists such as neurologists, psychiatrists, psychologists, gastrointestinal or colorectal specialists, urologists, primary care physicians, and physical therapists to achieve best outcomes.
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Medical Professionals can learn about various considerations concerning neuromodulation and clinic contacts. Once your preliminary questions have been answered, please use the Contact Us facility to find out more and to discuss specific objectives. Others may simply wish to join the INS and one of its related chapter societies, please use Membership Application.
Clinical trials that involve a wide range of emerging neuromodulation approaches are listed on our Resources and Research pages. Neuromodulator trials address symptom control through nerve stimulation in such condition categories as:
If you are not a medical professional and you are searching for information about neuromodulation and how these types of treatment could benefit a specific condition such as treatment-resistant headache or other chronic pain syndromes, you may find the sections titled Therapies, About Neuromodulation or FAQs particularly helpful.
The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation - the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its peer-reviewed journal Neuromodulation: Technology at the Neural Interface, explanatory content, and chapter websites.
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