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World's First Deep Brain Stimulation Device Approved for Treatment of Psychiatric Condition in Europe
Date:7/14/2009

TOLOCHENAZ, Switzerland, July 14 /PRNewswire-FirstCall/ --

- CE Mark Approval for Medtronic's Reclaim(R) DBS Therapy for Treatment of Chronic, Severe Obsessive-Compulsive Disorder

Medtronic today announced that Reclaim(R) Deep Brain Stimulation (DBS) Therapy has received CE (Conformite Europeene) Mark approval for the treatment of chronic, severe treatment-resistant obsessive-compulsive disorder (OCD).* This is the first time that a deep brain stimulation therapy has gained approval in Europe for the treatment of a psychiatric disorder.

Following CE Mark approval, Medtronic will conduct a multi-national post-market study to commence in at least eight sites in Europe. In addition to following any adverse events associated with the therapy, the study will further evaluate improvements seen in OCD symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), before deep brain stimulation to 12 months after.

Professor Loes Gabriels from the Catholic University of Leuven, Belgium, and lead investigator of the post-market study comments: "For patients with severe OCD who have tried and failed treatment through the treatment algorithm, DBS could result in a significant improvement of a disease that severely impacts on their lives. This study will be important in reinforcing the evidence base of DBS in the treatment of psychiatric conditions."

European centres first pioneered the technique of deep brain stimulation and the Catholic University of Leuven in Belgium was a leading contributor to the clinical evidence which was used to obtain CE mark approval in Europe as well as FDA approval in the United States (obtained in February 2009 through a humanitarian device exemption).

Previous research into DBS therapy for OCD, recently published in the journal Molecular Psychiatry, revealed clinically meaningful symptom reductions a
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SOURCE Medtronic, Inc.
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