- CE Mark Approval for Medtronic's Reclaim(R) DBS Therapy for Treatmentof Chronic, Severe Obsessive-Compulsive Disorder
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Medtronic today announced that Reclaim(R) Deep Brain Stimulation (DBS)Therapy has received CE (Conformite Europeene) Mark approval for thetreatment of chronic, severe treatment-resistant obsessive-compulsivedisorder (OCD).* This is the first time that a deep brain stimulation therapyhas gained approval in Europe for the treatment of a psychiatric disorder.
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Following CE Mark approval, Medtronic will conduct a multi-nationalpost-market study to commence in at least eight sites in Europe. In additionto following any adverse events associated with the therapy, the study willfurther evaluate improvements seen in OCD symptoms as assessed by theYale-Brown Obsessive Compulsive Scale (Y-BOCS), before deep brain stimulationto 12 months after.
Professor Loes Gabriels from the Catholic University of Leuven, Belgium,and lead investigator of the post-market study comments: "For patients withsevere OCD who have tried and failed treatment through the treatmentalgorithm, DBS could result in a significant improvement of a disease thatseverely impacts on their lives. This study will be important in reinforcingthe evidence base of DBS in the treatment of psychiatric conditions."
European centres first pioneered the technique of deep brain stimulationand the Catholic University of Leuven in Belgium was a leading contributor tothe clinical evidence which was used to obtain CE mark approval in Europe aswell as FDA approval in the United States (obtained in February 2009 througha humanitarian device exemption).
Previous research into DBS therapy for OCD, recently published in thejournal Molecular Psychiatry, revealed clinically meaningful symptomreductions and functional improvement in about two-thirds of patients anddemonstrated that a majority of patients moved from a severe OCD rating atthe start of the study to a mild or moderate rating at various follow-uppoints after device implantation.
The studies also highlighted the importance of a multidisciplinaryapproach to treating OCD with deep brain stimulation therapy.
Prof Nuttin, neurosurgeon at the Catholic University of Leuven in Belgiumcomments: "It is clear that for the best results a multidisciplinary teamconsisting of a psychiatrist and neurosurgeon plus several other importantspecialties must be involved when selecting, treating and managing thelong-term follow-up for a patient who undergoes deep brain stimulation forOCD."
OCD affects 2 percent of the population and it is estimated that forpatients with chronic, severe treatment-resistant OCD, more than 1,000patients per year could benefit from Reclaim DBS Therapy for OCD in WesternEurope. Patients with severe OCD, as defined by a Y-BOCS score over 30, andwho have tried at least three selective serotonin reuptake inhibitors (SSRIs)without treatment success, may be considered eligible for Reclaim DBS therapy.
The neurostimulators used for Reclaim DBS Therapy are the same as thoseused to treat common movement disorders like Parkinson's disease anddystonia. However, because the area of the brain targeted for OCD isdifferent, a unique DBS lead has been specially designed by Medtronic.
"Deep brain stimulation therapies were pioneered by Medtronicneuromodulation and to date, with more than 20 years of experience, 60,000people worldwide have benefited from Medtronic DBS therapy for Parkinson'sdisease, essential tremor and dystonia," said Karl Schweitzer, vice presidentfor Medtronic's Neuromodulation business in Europe. "This approval marks theworld's first steps into DBS for Psychiatric disorders and demonstrates howMedtronic continues to lead the way in research, therapy indicationexpansion, and technology."
*Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation ofthe anterior limb of the internal capsule, AIC, as an adjunct to medicationsand as an alternative to anterior capsulotomy for treatment of chronic,severe, treatment-resistant obsessive-compulsive disorder (OCD) in adultpatients who have failed at least three selective serotonin reuptakeinhibitors (SSRIs).
About Reclaim DBS Therapy
Reclaim DBS Therapy is an adjustable, reversible and non-drug therapythat uses a surgically implanted medical device, similar to a pacemaker, todeliver carefully controlled electrical pulses to precisely targeted areas ofthe brain. The stimulation can be programmed and adjusted non-invasively(without surgery) by a trained clinician to find the most appropriate typeand amount of stimulation for each patient to maximize symptom control andminimize side effects.
For OCD and treatment-resistant depression; a further psychiatricdisorder which Medtronic is currently exploring with Reclaim DBS therapy in amulti-center randomized clinical trial; the anatomical target in the brain isthe anterior limb of the internal capsule (AIC), and more specifically, aregion sometimes referred to as the ventral capsule/ventral striatum (VC/VS),which is a central node in the neural circuits believed to regulate mood andanxiety.
About OCD
People with OCD have persistent, upsetting thoughts (obsessions) and userituals (compulsions) to control the anxiety these thoughts produce. If OCDbecomes severe, it can keep a person from working or carrying out normaldaily activities. Standard treatments such as medications and cognitivebehavioral therapy (CBT) fail to work for a subset of people with OCD.
Medtronic's Leadership in DBS for Psychiatric Disorders
Medtronic has been pursuing research of DBS for psychiatric disorders formore than a decade in collaboration with physicians from many leadinginstitutions. The company holds several patents related to the technologiesused in DBS as well as the use of DBS for psychiatric disorders, includingfor treatment-resistant depression and OCD. To date, all peer-reviewedpublications about DBS for psychiatric disorders, includingtreatment-resistant depression, have been based on the use of Medtronic DBSsystems.
About Medtronic
Medtronic, Inc. (http://www.medtronic.com), headquartered in Minneapolis,is the global leader in medical technology - alleviating pain, restoringhealth, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertaintiessuch as those described in Medtronic's Annual Report on Form 10-K for theyear ended April 24, 2009. Actual results may differ materially fromanticipated results.Contacts: Jeff Warren Investor Relations +1-763-505-2696 Jon Pike Public Relations +44-1923-205-128
SOURCE Medtronic, Inc.
