Breaking 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 could be made next week. (Bloomberg)
Deep Brain Stimulation Shows Promise in Fight Against Alzheimer’s
August 6, 2010 - In their study of six patients from 2005-2008, Dr. Andres 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)
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)
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)
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)
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 has 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.
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)
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)
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)
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)
Medtronic to Invest $70M in BioControl
May 24, 2010 - Globes in Israel reports that Medtronic Inc. 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 the 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)
The Pentagon Supports 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)
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 its spinal cord stimulator
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)
A Study in the UK has found DBS and Medical Therapy for Parkinson's 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)
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 a new 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)
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)
Boston Scientific Eyes Sale of its Neuromodulation Division
April 9, 2010 - Reuters has 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)
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)
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