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Breaking News
Emerging Therapies & Diagnostic Tools
Deep Brain Stimulation Shows Promise in Fight Against Alzheimer’s
August 6, 2010 - In their study of six patients from 2005-2008, Dr. Andres M. Lozano and his team at Toronto Western Hospital have shown that using Deep Brain Stimulation (DBS) on patients with early signs of Alzheimer's disease is safe and may help improve memory or slow its deterioration. The results of the study are reported in the August 4th issue of The Annals of Neurology. (Science Daily)
EnteroMedics Receives Conditional FDA Approval for Obesity Trial
August 2, 2010 - EnteroMedics has cleared the first hurdle of getting an FDA approval to start its trial on the use of vagus nerve stimulation to treat obesity; however, more funding is necessary to move forward with the study. (Reuters)
Spinal Cord Stimulation Used to Treat Heart Failure
July 29, 2010 - Medtronic has announced that it is launching a clinical trial on the use of a spinal cord stimulator to treat heart-failure by improving blood flow and reducing inflammation. (Minneapolis St. Paul Business Journal)
Chip Holds Promise for Refining Brain Stimulation
July 9, 2010 - A Rehabilitation Nano Chip that can modulate the delivery of electrical stimulation to diseased parts of the brain by recording and analyzing brain activity, holds promise for enabling more precise and flexible DBS treatment for conditions such as Parkinson's Disease. The research team hopes to complete its experiments within the next six months and, within the next few years, start treating patients with neurological conditions. (cnet/crave)
Spinal Cord Stimulator Story Featured on BBC News
July 5, 2010 - The BBC featured a story of a patient in the U.K. whose chronic pain was successfully treated with neurostimulation - the first implant of Medtronic's Restore neurostimulator in Britain.
CVRx Reports Positive Four-Year Results for its Anti-Blood Pressure Device
June 21, 2010 - CVRx's four-year study revealed that patients being treated with its stimulator experienced a drop in blood pressure. The device stimulates the baroceptors in the carotid artery. The brain instructs the arteries to relax, which eases the flow of blood throughout the body, and the heart to slow down, allowing more time for the heart to fill with blood. (MedCity News)
FDA Clears The University of Alabama at Birmingham's Transcranial Magnetic Stimulator for the Treatment of Depression
June 8, 2010 - The FDA has approved use of UAB’s Repetitive Transcranial Magnetic Stimulation ( rTMS), to deliver highly focused, MRI-strength magnetic pulses to the brain. This therapy is indicated for people suffering from depression that is refractory to pharmacological treatment. (Birmingham Business Journal)
Vagus Nerve Stimulation for Autoimmune Diseases
June 1, 2010 - Setpoint Medical, a startup based in Boston, is developing a vagal nerve stimulator designed to modulate the immune system response associated with autoimmune diseases, such as inflammatory bowel disease and rheumatoid arthritis. The technology has been developed from ten years of animal research, studying how the vagus nerve carries signals between the brain and visceral organs, and plays a role in controlling inflammation. (MIT Technology Review)
Forthcoming Clinical Trail to Investigate Vagus Nerve Stimulation for the Treatment of Tinnitus
May 24, 2010 - MicroTransponder is adapting its neurostimulation technology, currently being developed for chronic pain, to stimulate the vagus nerve for tinnitus. Researchers plan to test the therapy in upcoming clinical trials in Belgium. (MIT Technology Review)
The Pentagon to Support Research on Optogenetic Technology
to Repair Injured Brains
May 12, 2010 - The U.S. Defense Advanced Research Projects Agency (DARPA) is investing $14.9 million in optogenetics research, for the development of implantable microdevices that may help restore brain function. The REPAIR project (for Reorganization and Plasticity to Accelerate Injury Recovery), will include researchers from Stanford University, Brown University, the University of California-San Francisco and University College London. (MedGadget)
A Study in the UK has Found DBS and Medical Therapy for Parkinson's Disease more Effective than Medical Therapy Alone
April 29, 2010 - The results of the 10-year study on 366 patients, funded by the charity Parkinson's UK, are published in The Lancet. (BBC News)
A Silk Brain Implant is Being Developed to Treat Epilepsy, Spinal Cord Injuries, and Other Neurological Disorders
April 18, 2010 - A brain implant consisting of protein from silk and thin metal electrodes holds promise for treating epilepsy, spinal cord injuries and other neurological disorders. The biocompatible silk dissolves into the brain and maximizes direct contact between the electrodes and the brain tissue. (Reuters)
Retinal Implant: First Results from Human Trial
March 19, 2010 - Retinal Implant AG from Reutlingen, Germany has announced the results of the first human trial of its subretinal implant. Eleven patients who lost their sight due to retinitis pigmentosa received the implant through surgical transchoroidal implantation. Energy was delivered to the implant via a retroauricular plug. Implantation was successful in all patients without any adverse events.The results of this clinical trial will be presented at the Association for Research in Vision and Ophthalmology’s (ARVO) annual meeting May 2-6 in Fort Lauderdale, Fla. (Medgadget)
Deep Brain Stimulation Reduces Epileptic Seizures in Patients with Refractory Partial and Secondarily Generalized Seizures
March 18, 2010 - A recent study organized by Stanford University researchers found patients with refractory partial and generalized seizures had a reduction in seizures after deep brain stimulation. This multi-center clinical trial determined that the benefits of stimulation of the anterior nuclei of thalamus for epilepsy (SANTE) persisted and by 2 years there was a 56% reduction in seizure frequency. Full findings of this study are available early online in Epilepsia, a journal published by Wiley-Blackwell on behalf of the International League Against Epilepsy. (Epilepsia, Wiley-Blackwell)
Hand-held device on trial for migraine sufferers
March 4, 2010 - A new hand-held device that delivers a magnetic pulse to the back of the head could become an alternative to drug treatment for people with migraines. The findings of a 200-person study, published in The Lancet Neurology, showed that the single-pulse transcranial magnetic stimulation (sTMS) from the device is a promising acute treatment for some patients with migraine with aura. (BBC News)
Imaging Advances Promote Growth of DBS
March 4, 2010 - Neurosurgeons are developing new tools to improve the implantation process. (Neurotech Business Report)
New MRI May Lead to Better Brain Pictures
March 1, 2010 - Researchers are reporting that they've developed a new kind of MRI sensor that can detect the neurotransmitter known as dopamine, potentially allowing doctors to get better views inside the brain. (Yahoo News: HealthDay News)
Study results send shares of Uroplasty climbing
March 1, 2010 - The results from a 220-patient clinical trial using the UrgentPC device to stimulate the tibial nerve in the ankle to treat urge incontinence and frequency urination, will be published in the April issue of the Journal of Urology. In the study, 58% of the patients experienced "moderately or markedly improved" symptoms, compared with 22% of the patients who received a simulated procedure. (Star Tribune)
Electric stimulation may help stroke victims swallow
February 24, 2010 - Tiny electric shocks to the throat may help stroke victims overcome disabling swallowing difficulties, a small British study suggests. (Reuters Health)
A Brain Implant that Uses Light - A novel optical device could ultimately be used to treat neurological disease
February 24, 2010 - Researchers at Medtronic are developing a prototype neural implant that uses light to alter the behavior of neurons in the brain. The device is based on the emerging science of optogenetic neuromodulation, in which specific brain cells are genetically engineered to respond to light. (Technology Review)
Implanted Sensor Could Provide Clues to Brain Chemistry
A system to detect brain chemicals may improve therapies for Parkinson's and other disorders.
February 16, 2010 - Over the last decade, deep brain stimulation, in which an implanted electrode delivers targeted jolts of electricity, has given surgeons an entirely new way to treat challenging neurological diseases. More than 75,000 people have undergone the procedure for Parkinson's and other disorders. But despite its success, scientists and surgeons know little about its actual effect on the brain or exactly why it works. (MIT Technology Review)
Test of "artificial pancreas" offers diabetes hope. Study is first test to prove new device improves care
February 4, 2010 - Scientists have used an "artificial pancreas" system of pumps and monitors to improve blood sugar control in diabetes patients in the first study to show the new device works better than conventional treatment. (Reuters)
Brain Scans Suggest Some Vegetative Patients May Be Aware
February 3, 2010 - Some patients thought to be in a vegetative state actually show signs of consciousness when assessed with a brain scan. (Yahoo News)
Depression could be big market for device companies
January 29, 2010 - Medical device companies could play a greater role in the depression treatment market in the US in coming years, according to a new report. About 15-20 million people in the US suffer from depression, representing a potential market valued at about $16bn, information provider Kalorama (Requires a subscription on www.Clinica.co.uk)
Neuroengineers silence brain cells with multiple colors of light
New tools show potential for treating brain disorders
January 6, 2010 - Neuroscientists at MIT have developed a powerful new class of tools to reversibly shut down brain activity using different colors of light. When targeted to specific neurons, these tools could potentially lead to new treatments for the abnormal brain activity associated with disorders such as chronic pain, epilepsy, brain injury, and Parkinson’s disease. (MIT News)
Pivotal Study Of Medtronic Deep Brain Stimulation Therapy Shows Long-Term Reduction In Seizure Rate In Patients With Severe Epilepsy
December 09, 2009 - Long-term data from an investigational study of Deep Brain Stimulation (DBS) Therapy for Epilepsy was released this week by Medtronic, Inc. at the American Epilepsy Society Meeting (AES) in Boston. The results of the study show improvement over time... (Medical News Today)
Surgeon put electrodes in my back to cure my chronic pain
April 28, 2009 - Many thousands of Britons suffer from chronic pain as a result of nerve damage. While prescription medicine works for most, others may benefit from treatment with implanted electrodes. Mark Hollingworth, 43, an IT specialist from Essex, had the operation in March. He reveals his story while his doctor explains the procedure. (Daily Mail Online U.K.)
Device Complications
Studies Link Rare Ailment to Pain Pumps
January 26, 2010 - (New York Times)
Government and Regulatory Issues
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
Stryker Purported to Be in Talks with Boston Scientific's Neuromodulation Division
August 17, 2010 - Bloomberg has reported that Stryker Corp., a maker of artificial hips and knees, is in advanced talks to buy Boston Scientific's Neuromodulation division for about $1.5 billion. If an agreement is reached, the announcement may be made next week. (Bloomberg)
FDA Approves Boston Scientific Leads
August 2, 2010 - Boston Scientific Corp. was granted U.S. Food & Drug Administration approval for leads designed for use in its Precision Plus spinal cord stimulator system. (MedCity News)
EndoStim raises $6M in Venture Capital
July 19, 2010 - EndoStim Inc., a start-up company that is making microstimulators to treat gastrointestinal and urological neuro-muscular disorders, has reported that it had raised $6 million in Series B equity financing. EndoStim would invest the money to continue clinical trials and pursue FDA approval for gastroesophageal reflux disease and urinary urge incontinence. (St. Louis Business Journal)
Neuros Medical Receives U.S. Government Funding for Stimulator to Treat Amputees' Pain
July 2, 2010 - The U.S. Department of Defense has awarded $1.5 Million for the development of its neurostimulator to treat the chronic pain suffered by amputees, known as stump or phantom limb pain. The award's purpose is to “advance state-of-the-art solutions for world-class medical care with an emphasis on post-traumatic stress disorder, traumatic brain injury, prosthetics, restoration of eyesight and advancing eye care, and other conditions directly relevant to the injuries our service members are currently receiving on the battlefield”. (MedCity News)
Boston Scientific Corp. Has Released Two New Spinal Cord Stimulation Lead Splitters
June 24, 2010 - The new design enables multi-site placement of up to four spinal cord leads, which will enable a greater range of lead configurations and treatment options. (MedCity News)
St. Jude Medical's Epiducer lead delivery system for neurostimulation therapy receives CE Mark approval
May 27, 2010 – St. Jude Medical, Inc., today announced European CE Mark approval of its new Epiducer™ lead delivery system for neurostimulation therapy. Unveiled at the Neurosurgery 2010 Congress in Lyon, France, the Epiducer lead delivery system allows the introduction of S-Series perc-paddle leads as well as multiple lead arrays through a single percutaneous entry point, thus obviating the need to perform a laminotomy. (Med City News)
Spin-Off Device Companies Draw Venture Capital
May 26, 2010 - Some of the larger device companies have accumulated more technology than they can fully pursue and, rather than abandoning potentially beneficial therapies, they are spinning off these low-priority products into new start-ups. Biotech venture firms have been known to back pharmaceutical spin-offs and now they are looking to do the same with device technology. (Wall Street Journal)
Medtronic to Invest $70M in BioControl
May 24, 2010 - Globes in Israel reports that Medtronic Inc. (NYSE: MDT) will invest $70 million in a start-up company, BioControl Medical Ltd., which has developed a vagal nerve stimulator to treat heart failure. (Globes)
Dysphagia Wins a $25,000 Grant from the Innovation Fund of the Lorain County Community College Foundation
May 24, 2010 - Dysphagia will use this grant to develop a prototype of its neurostimulator for clinical trials. The device, which uses a sensor in the mouth to detect a "swallow event", stimulates the trachea to close off the airway when food is being swallowed. (Massachusetts Medical Devices Journal)
Medtronic begins new spinal cord stimulator trials
May 6, 2010 - Medtronic has announced a U.S. clinical trail for its RestorSensor Neurostimulator for the treatment of Chronic pain. The device automatically adjusts the stimulation strength, based on the patient's body position and activity. Ten U.S. medical centers will enroll patients in the study. The device already has received European approval. (Minneapolis St. Paul Business Journal)
Boston Scientific begins ‘Evidence’ clinical trial for Precision Plus spinal device
May 3, 2010 - Boston Scientific has enrolled the first patient in the 132-patient trial, in which researchers will compare its spinal cord stimulator system with revision surgery for the treatment of failed back surgery syndrome. (Med City News)
Boston Scientific Eyes Selling its Neuromodulation Division
April 9, 2010 - Reuters reported that Boston Scientific, in the aftermath of a costly recall of certain heart defibrillators and debt following its 2006 acquisition of Guidant Corp., is considering selling its neuromodulation and neurovascular intervention businesses. Abbott Laboratories and Johnson & Johnson have been identified as potential bidders for the neuromodulation business. (Reuters)
St. Jude Medical Receives Australian TGA Regulatory and Reimbursement Approval for its Rechargeable Deep Brain Stimulator for Parkinson’s Disease
March 23, 2010 - St. Jude Medical, Inc. reported that its Brio deep brain stimulation system to treat Parkinson's disease symptoms received the Australian Therapeutic Goods Administration's regulatory and reimbursement approval. (RTTNews)
The Cleveland Clinic partners with Irish companies to develop new devices
March 23, 2010 - The Cleveland Clinic has partnered with Irish start-up companies to support the development of new medical devices. The Clinic also has teamed with The Royal College of Surgeons of Ireland and the Centre of Innovation in Surgical Technology. (Irish Times)
FDA panel backs Medtronic brain stimulator
March 12, 2010 - Federal health advisers say a brain stimulating device from Medtronic can be approved for epilespy, provided the company conducts follow-up safety studies. (Associated Press / Star Tribune)
FDA: Medtronic brain stimulator missed study goal
March 10, 2010 - The Food and Drug Administration said Wednesday a nerve stimulating implant from Medtronic failed to significantly reduce seizures in epilepsy patients. Medtronic attributed the missed study goal to one patient who experienced a massive percent increase in seizures in the month after implantation. (Associated Press / Star Tribune)
Neurotech Reports Teams with International Neuromodulation Society for Online Database
March 4, 2010 - The new Online Database of Neuromodulation Products offers comprehensive information on existing and forthcoming products to treat neurological disorders and diseases. (Neurotech Business Report)
Epilepsy Market Poised for New Device Competition
March 4, 2010 - NeuroPace and Medtronic will soon join Cyberonics in the epilepsy device market. (Neurotech Business Report)
EnteroMedics CEO Offers Explanation for Failed Obesity Trial
March 4, 2010 - The failure may stem from an unexpected therapeutic effect in the control arm of the study. (Neurotech Business Report)
Commentary: Focus on Epilepsy
March 4, 2010 - Editor James Cavuoto comments on the market opportunity for neurosensing systems and neurosurgical tools created by neurosurgical treatment for epilepsy. (Neurotech Business Report)
OrbiMed Advisors raises $550M for health venture fund
February 22, 2010 - OrbiMed Advisors, which has invested in Ohio companies Athersys Inc. and ViewRay, has raised $550 million for its latest health venture capital fund. OrbiMed plans to invest 60 percent of the fund in biotechnology, 30 percent in medical devices and 10 percent in diagnostics, and will back a total of 25 to 30 companies, according to VentureWire. (Med City News)
MicroTransponder Inc. raises $7M
February 24, 2010 - The Austin company is testing a wireless neurostimulation platform that will treat chronic pain and other neurological indications. MicroTransponder did not name the investors, but said the latest contribution came from existing funders and angel investors. (Austin Business Journal)
Medtronic's Reclaim Deep Brain Stim Approved for Some OCD Sufferers
February 20, 2009 - Medtronic's Reclaim deep brain stimulation system has received a humanitarian device exemption (HDE) from the FDA for treatment of severe cases of obsessive-compulsive disorder (OCD). (medGadget)
Case Western Reserve University licenses neuromodulation technology to Pennsylvania company
February 17, 2010 - Case Western Reserve University has licensed to a Pennsylvania company the right to make and sell three types of electrodes and a control unit used by researchers to do their neuromodulation work. (Med City News)
Medical Device Entrepreneurs Converge on Wings, a New Angel Investing Network
February 16, 2010 - People who make a living creating medical devices, like ultrasound machines or stents to prop open clogged arteries, have lived through a crummy 18 months. But that’s not discouraging a group of prominent medical device entrepreneurs from Seattle who are building the region’s first dedicated network of angel investors who have the money and expertise to bankroll new med-tech startups. (Xconomy News)
Medtronic launches 2 brain stimulation products
February 16, 2010 - Medtronic Inc. said Tuesday it began marketing two surgically implanted devices that are intended to help relieve symptoms for patients with neurodegenerative diseases. (AP / SFGate.com)
Chip maker Zarlink puts big bet on medical sector
February 12, 2010 - Five years after Kirk Mandy's return to resurrect Zarlink Semiconductor ZL.TO, the chief executive says the "heavy lifting" is done and it is time to see if strategic wagers will pay off for the one-time Canadian high-tech leader. (Reuters Canada)
Celebrating 30 Years Of Innovation In Neuromodulation, St. Jude Medical Unveils Latest Product At American Academy Of Pain Medicine Annual Meeting
February 4, 2010 - St. Jude Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) clearance of the Swift-Lock(TM) anchor, a new product designed to help physicians efficiently secure neurostimulation leads utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. (Medical News Today)
St. Jude Medical Announces Approval And Launch Of Neurostimulation System In Japan
January 19, 2010 - St. Jude Medical, Inc. announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Genesis(TM) spinal cord stimulation system for the management of chronic pain. (Medical News Today)
St. Jude Medical Receives FDA Approval for Industry-First Five-Column Neurostimulation Lead to Manage Chronic Pain
December 4, 2009 - St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. market introduction of its new Penta™ surgical lead for neurostimulation therapy. Unveiled at the annual North American Neuromodulation Society meeting... (Genetic Engineering and Biotechnology News)
Press Releases
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
31 Dec 2007
NeuroInsights - Highlights of the International Neuromodulation Society World Congress
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
mediLexicon- 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
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