Healthcare Industry News: neuromodulation
News Release - February 19, 2009
Medtronic Receives FDA HDE Approval to Commercialize the First Deep Brain Stimulation (DBS) Therapy for a Psychiatric Indication in the United StatesFDA Approves Medtronic’s Reclaim™ DBS Therapy for Chronic, Severe Obsessive-Compulsive Disorder;
Medtronic Initiates Multi-Center Trial of DBS for Treatment-Resistant Depression
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ), announced today its official entrance into psychiatric therapies with approval from the U.S. Food and Drug Administration (FDA) for a humanitarian device exemption (HDE) for its Reclaim™ Deep Brain Stimulation (DBS) Therapy for chronic, severe obsessive-compulsive disorder (OCD). The company also announced the first enrollment in its multi-center, randomized clinical trial of DBS for treatment-resistant depression. Medtronic is proceeding with U.S. FDA Investigational Device Exemption (IDE) approval for five centers to enroll patients in the clinical trial of DBS for treatment-resistant depression throughout the United States, including the Cleveland Clinic, which was the first to enroll a patient in the trial.
Reclaim DBS is the first medical device to receive U.S. FDA approval for the treatment of OCD and is also the first psychiatric indication to be approved for DBS. While OCD is estimated to affect one in 50 adults in the United States, it is anticipated that DBS therapy will be appropriate for a small subset of the patient population, below the threshold of 4,000 patients per year allowed under an HDE. Medtronic plans to make Reclaim DBS Therapy for OCD available in the United States by mid-2009.
“In the most severe cases, OCD causes profound impairment in work and social life, as well as tremendous suffering,” said Benjamin D. Greenberg, M.D., Ph.D., associate professor of psychiatry at Butler Hospital and the Alpert Medical School of Brown University. Dr. Greenberg led some of the very first uses of DBS for OCD in the United States in 2000. He is principal investigator in a new clinical trial of DBS for OCD sponsored by the National Institutes of Mental Health (NIMH). “Our work, plus that of colleagues in Europe, shows that DBS is a promising treatment for a subset of patients with OCD who have remained very ill and debilitated despite aggressive use of medications and cognitive behavioral therapy.”
“For patients with OCD, DBS therapy represents an alternative therapeutic approach, which may be an option for patients who did not experience a benefit from more traditional treatments,” said Ali Rezai, M.D., neurosurgeon at Cleveland Clinic and investigator in early studies of DBS for OCD. Dr. Rezai is also a co-lead investigator in the clinical trial for depression. “The clinical trial of DBS in treatment-resistant depression is an important step in understanding this therapeutic approach for patients with severe depression.”
Study Results of DBS for OCD
Collaborative clinical research of DBS therapy using Medtronic devices began in 1998 with the first implant in Europe (the Catholic University of Leuven in Belgium). The research was also conducted at three U.S. medical centers (Butler Hospital in Providence, R.I., Cleveland Clinic, and University of Florida, Gainesville). These institutions studied DBS therapy in 26 patients with severe, treatment-resistant OCD and the data from the studies were consolidated and recently published in the journal, Molecular Psychiatry. The combined long-term results of those studies reveal clinically meaningful symptom reductions and functional improvement in about two-thirds of patients. In addition, a majority of the 26 patients moved from a severe OCD rating at the start of the study to a mild or moderate rating at various follow-ups after device implantation. The reductions in OCD symptoms were associated with marked functional improvements in psychological, social and occupational domains.
As the authors reported in the publication, a total of 23 serious adverse events were reported in 11 subjects (42 percent) of which 15 of the 23 events were associated with the surgical implant procedure, device, or therapy, all of which were resolved without sequelea. Adverse events such as changes in mood and anxiety were transient and most of them resolved with stimulation parameter changes. The studies show DBS for OCD may hold promise as a therapy when there is a dedicated interdisciplinary team that is expert in patient selection, implantation, stimulation and the long-term management of severely ill psychiatric patients.
More information on Reclaim DBS Therapy is available at www.medtronic.com/ocd.
Multi-Center Trial of DBS for Treatment-Resistant Depression
Medtronic’s multi-center, randomized, controlled clinical trial of DBS for treatment-resistant depression will evaluate the potential for DBS therapy in patients who have not benefitted from more traditional treatments, including medications. The lead investigator team at Cleveland Clinic of Drs. Malone and Rezai enrolled the first patient and will perform the first implant in this study. More information is available via the website, www.clinicaltrials.gov.
“This patient population is so severely impacted by their disease that they struggle to engage in social activities or even daily tasks,” said Donald Malone, M.D., psychiatrist at Cleveland Clinic and co-lead investigator in the trial. “This clinical trial is an important step forward in evaluating this therapy in a severely depressed patient population where currently available treatments have not provided relief.”
Study Results of DBS for Treatment-Resistant Depression
Medtronic has been pursuing research of DBS for psychiatric disorders for more than a decade in collaboration with physicians from many leading institutions. The first DBS implant for treatment-resistant depression was performed in a physician-sponsored study supported by Medtronic at Butler Hospital in Providence, R.I. in 2003.
A study recently published in the scientific journal, Biological Psychiatry, showed the results in 15 patients with chronic, severe, highly refractory depression who received open-label DBS at three collaborating clinical sites: Butler Hospital in Providence, R.I.; Cleveland Clinic; and Massachusetts General Hospital in Boston. Stimulation was programmed to deliver therapeutic benefit while minimizing any adverse effects. The results showed sustained improvement in mean depression measures. Although follow-up durations varied, at last observation, five of the 15 patients met accepted Montgomery-Asberg Depression Rating Scale (MADRS) criterion for remission and eight of the 15 patients met accepted MADRS criterion for meaningful clinical response.
Despite the surgical nature of DBS treatment, patients tolerated both the surgical procedure and stimulation well. The surgical/procedure and device-related adverse events were similar in profile to DBS for movement disorders (e.g. Parkinson’s disease). Adverse events related to this severity of psychiatric illness, such as acute changes in mood and anxiety, also were reported in the study and were rapidly reversed through stimulation parameter changes. None of the adverse events reported in the publication resulted in removal of the DBS system or withdrawal from the study. All patients were continuing on DBS therapy at the time of publication (last reported follow-up). However, more research is needed to determine the safety and efficacy of this potential therapy.
“We are pleased to receive the HDE for Reclaim DBS that will allow us to provide this therapy as an option for people with severe OCD. Medtronic pioneered DBS therapy and to date, more than 55,000 people worldwide have received our Activa® DBS therapies for the symptoms of advanced Parkinson’s disease, essential tremor and dystonia,” said Richard E. Kuntz, M.D., president of the neuromodulation business and senior vice president at Medtronic. “Our work within deep brain stimulation for treatment-resistant depression also now culminates in a carefully designed, randomized, controlled trial to provide the data patients and their physicians will need to guide future therapeutic choices.”
About Reclaim DBS Therapy
Reclaim DBS is an adjustable, reversible and non-drug therapy that uses a surgically implanted medical device, similar to a pacemaker, to deliver carefully controlled electrical pulses to precisely targeted areas of the brain. The stimulation can be programmed and adjusted non-invasively (without surgery) by a trained clinician to find the most appropriate type and amount of stimulation for each patient to maximize symptom control and minimize side effects.
The neurostimulators used for Reclaim DBS are the same as those used to treat common movement disorders like Parkinson’s disease. However, because the area of the brain targeted is different, a unique DBS lead was specially designed. For OCD and treatment-resistant depression, the anatomical target in the brain is the anterior limb of the internal capsule (AIC), and more specifically, a region sometimes referred to as the ventral capsule/ventral striatum (VC/VS), which is a central node in the neural circuits believed to regulate mood and anxiety.
People with OCD have persistent, upsetting thoughts (obsessions) and use rituals (compulsions) to control the anxiety these thoughts produce. If OCD becomes severe, it can keep a person from working or carrying out normal daily activities. Standard treatments such as medications and cognitive behavioral therapy (CBT) fail to work for a subset of people with OCD.
Humanitarian Use Devices (HUDs) facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the United States every year. To receive approval of a “Humanitarian Device Exemption” (HDE) application, a company must demonstrate the product's safety and probable benefit. For any center in the United States to be able to offer DBS for OCD, approval is required from their own Institutional Review Board (IRB), a committee that approves, monitors and reviews research within that center.
About Treatment-Resistant Depression
Depression is a serious medical illness estimated to affect more than 20 million Americans each year. According to the National Institute for Mental Health, some of the symptoms include persistent sad, anxious or “empty” mood, feelings of hopelessness or pessimism, feelings of guilt, worthlessness or helplessness, or loss of interest or pleasure in hobbies and activities that were once enjoyed. If a person has recurring episodes of depression that are not helped by traditional medications or behavioral therapy, they may be suffering from a severe form known as treatment-resistant depression.
Medtronic’s Leadership in DBS for Psychiatric Disorders
Medtronic has been pursuing research of DBS for psychiatric disorders for more than a decade in collaboration with physicians from many leading institutions. The company holds several patents related to the technologies used in DBS as well as the use of DBS for psychiatric disorders, including for treatment-resistant depression and OCD. To date, all peer-reviewed publications about DBS for psychiatric disorders, including treatment-resistant depression, have been based on the use of Medtronic DBS systems. Medtronic also remains the only company with a commercially available DBS system (Activa DBS Therapy) currently approved by the U.S. FDA for management of symptoms of movement disorders not adequately controlled by medications, including Parkinson’s disease, essential tremor and dystonia.
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 25, 2008. Actual results may differ materially from anticipated results.
Drs. Malone and Rezai are employed physicians of Cleveland Clinic. Medtronic has subsidized a portion of Dr. Malone’s compensation from Cleveland Clinic in return for consultancy services. Dr. Rezai has served as a paid consultant and speaker for Medtronic.
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