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World's First Deep Brain Stimulation Device Approved for Treatment of Psychiatric Condition in Europe

Posted on: Tuesday, 14 July 2009, 10:04 CDT

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 and functional improvement in about two-thirds of patients and demonstrated that a majority of patients moved from a severe OCD rating at the start of the study to a mild or moderate rating at various follow-up points after device implantation.

The studies also highlighted the importance of a multidisciplinary approach to treating OCD with deep brain stimulation therapy.

Prof Nuttin, neurosurgeon at the Catholic University of Leuven in Belgium comments: "It is clear that for the best results a multidisciplinary team consisting of a psychiatrist and neurosurgeon plus several other important specialties must be involved when selecting, treating and managing the long-term follow-up for a patient who undergoes deep brain stimulation for OCD."

OCD affects 2 percent of the population and it is estimated that for patients with chronic, severe treatment-resistant OCD, more than 1,000 patients per year could benefit from Reclaim DBS Therapy for OCD in Western Europe. Patients with severe OCD, as defined by a Y-BOCS score over 30, and who 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 those used to treat common movement disorders like Parkinson's disease and dystonia. However, because the area of the brain targeted for OCD is different, a unique DBS lead has been specially designed by Medtronic.

"Deep brain stimulation therapies were pioneered by Medtronic neuromodulation and to date, with more than 20 years of experience, 60,000 people worldwide have benefited from Medtronic DBS therapy for Parkinson's disease, essential tremor and dystonia," said Karl Schweitzer, vice president for Medtronic's Neuromodulation business in Europe. "This approval marks the world's first steps into DBS for Psychiatric disorders and demonstrates how Medtronic continues to lead the way in research, therapy indication expansion, and technology."

*Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

About Reclaim DBS Therapy

Reclaim DBS Therapy 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.

For OCD and treatment-resistant depression; a further psychiatric disorder which Medtronic is currently exploring with Reclaim DBS therapy in a multi-center randomized clinical trial; 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.

About OCD

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.

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.

About Medtronic

Medtronic, Inc. (http://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 24, 2009. Actual results may differ materially from anticipated results.

Contacts: Jeff Warren Investor Relations +1-763-505-2696 Jon Pike Public Relations +44-1923-205-128

SOURCE Medtronic, Inc.

Source: PR Newswire

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