Deep brain stimulation device could help treatment of obsessive compulsive disorder

28 March 2005

Minneapolis, USA. Medtronic, Inc. (NYSE:MDT) announced that the US Food and Drug Administration (FDA) has designated the company's Activa Deep Brain Stimulation (DBS) Therapy as a Humanitarian Use Device (HUD) for the treatment of chronic, treatment-resistant obsessive compulsive disorder (OCD) as an alternative to anterior capsulotomy, a form of destructive, irreversible neurosurgery.

This special FDA designation may make the use of Medtronic's leading DBS therapy possible among patients with this disorder under a Humanitarian Device Exemption (HDE).(1) The company expects to file an HDE application for the condition later this year.

"Obsessive compulsive disorder is not rare, but some people with severe OCD never find adequate relief from its debilitating and disruptive symptoms with existing treatment options," said Jon Tremmel, president, Medtronic Neurological. "These patients deserve a better quality of life, which is one of the main reasons why we are pursuing this much needed therapy."

According to the National Institute of Mental Health, OCD affects about 3.3 million adult Americans. Standard treatments such as pharmacotherapy and Cognitive Behavioral Therapy (CBT) fail to work for a subset of these patients. Those who have suffered for more than five years with chronic, treatment-resistant OCD, and who are candidates for anterior capsulotomy, fall within the HUD designation for DBS.

"Improving access to our leading DBS therapy is another way in which Medtronic hopes to better patients' overall health," said Tremmel. "Our work in OCD, and research in depression demonstrate our commitment to the psychiatric field, and to patients with very few treatment options."

Medtronic is currently conducting a clinical trial in the U.S. for the Intercept Epilepsy Control System, the company's brain stimulation therapy that may reduce seizure rates in patients with epilepsy.

More information regarding Medtronic's Activa Therapy, including approved indications and safety information is available at

(1) About Humanitarian Use Devices (HUDs) and Humanitarian Device Exemptions (HDEs)

The FDA defines HUDs as devices used in the treatment of rare medical conditions (less than 4000 per year in the US). After an HUD designation is made, the company has the opportunity to submit data supporting safety and probable benefit for the affected population. If the FDA then determines the device meets these criteria, it will grant an HDE, allowing for qualified distribution and use of the device for the specific indication.

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