Healthcare Industry News: neuromodulation
News Release - April 28, 2008
Clinical Data on the Use of Medtronic's Deep Brain Stimulation System for Psychiatric Disorders to Be Presented at International Neurosurgical MeetingData Represents the Largest and Longest Clinical Experience with DBS for Severe Psychiatric Disorders
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced that data on the use of its deep brain stimulation (DBS) system for severe, treatment resistant depression and obsessive compulsive disorder (OCD) will be presented by Ali Rezai, M.D., neurosurgeon at the Cleveland Clinic and investigator in the research, at the annual scientific meeting of the American Association of Neurological Surgeons (AANS). The data represent the largest and longest clinical experience to date with DBS for psychiatric disorders and was collected through the collaborative research efforts of several leading institutions. All of the studies being presented used the Medtronic DBS system to stimulate a target within the brain called the ventral anterior limb of the internal capsule/ventral striatum (VC/VS), which is a central node in the neural circuits that regulate mood and anxiety.
“The data we are presenting on 43 patients is the result of more than 10 years of work across multiple institutions worldwide. These data represent the largest number and the longest evaluation of patients with psychiatric disorders who have undergone DBS implants, including some with long-term follow up,” said Dr. Rezai, who represented an international working group of physicians studying DBS therapy for treatment resistant OCD and depression. “While OCD and depression treatment with DBS require additional clinical evaluation research, our early open-label experience to date is encouraging and indicates that DBS may help severely disabled and suffering patients who have exhausted other treatment options.”
Medtronic, in collaboration with leading physicians from around the world, has pioneered the use of DBS for movement disorders, including Parkinson’s disease, essential tremor and dystonia. Medtronic has been pursuing research of DBS for psychiatric disorders with physicians from many leading institutions, including those that were part of the research being presented this week that was supported by Medtronic: Cleveland Clinic; Brown University in Providence, R.I.; the University of Florida in Gainesville; the Catholic University of Leuven in Belgium; and Massachusetts General Hospital in Boston. This research into DBS for psychiatric disorders started more than a decade ago with the first DBS implant for the treatment of OCD in 1998 at the Catholic University in Leuven, Belgium. The first DBS implant for treatment resistant depression was performed at Butler Hospital in Providence, R.I., in 2003.
DBS for Obsessive Compulsive Disorder (OCD)
Data on DBS for OCD will be presented by Dr. Rezai today, Monday, April 28, at 2:45 p.m. central time. These data are from 26 patients with a history of severe, disabling treatment resistant OCD of at least five years who received a Medtronic DBS system. Follow-up data on these patients range from three months to three years.
DBS for Severe Treatment Resistant Depression
Data on the use of DBS for treatment resistant depression will be presented by Dr. Rezai on Tuesday, April 29 at 10:30 a.m. central time. These data include results from 17 patients with severe, treatment resistant depression who had failed multiple medical and electroconvulsive therapy trials and underwent an implant of a Medtronic DBS system. Following a survey of acute effects from various stimulation settings, each patient received individualized programmed stimulation. All 17 patients have reached six months of follow-up post-implant. Sixteen of the patients have been followed for a minimum of one year, with a mean of 22.8 months of follow-up.
“We are pleased to have reached this milestone in Medtronic’s 10-year history of investigating DBS therapy for psychiatric disorders,” said Richard E. Kuntz, M.D., corporate senior vice president and president of the neuromodulation business at Medtronic. “These data represent the ongoing collaboration of psychiatrists, psychologists and neurosurgeons from several leading institutions and Medtronic and will help to further define the potential for DBS in treating a spectrum of neurological disorders.”
Medtronic’s Leadership in DBS
While DBS therapy is investigational for both depression and OCD, Medtronic plans to continue its work with leading neurosurgeons, psychiatrists and psychologists to initiate a trial of DBS for severe, treatment resistant depression in 2008. Medtronic is also pursuing a humanitarian device exemption (HDE) for DBS in OCD. Medtronic is the only company with a commercially available DBS system approved by the U.S. Food and Drug Administration (FDA) for Parkinson’s disease and essential tremor, as well as for dystonia under an HDE. To date, Medtronic’s DBS system has been implanted in more than 40,000 patients worldwide.
DBS is an adjustable, reversible, non-destructive and non-drug therapy using a surgically implanted medical device, similar to a pacemaker, to deliver carefully controlled electrical pulses to precisely targeted areas of the brain. Electrical stimulation is delivered to the brain regions that control functions such as movement or mood to seek improvements in clinical symptoms. The stimulation can be programmed and adjusted non-invasively (without surgery) by a trained clinician to maximize symptom control and minimize side effects.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
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