Medtronic Receives Humanitarian Use Device Designation for Treatment of OCD

Den amerikanske virksomhed Medtronic vil snart søge godkendelse hos den amerikanske lægemiddelstyrelse Food and Drug Agency om godkendelse af deres produkt Activa til behandling af behandlingsresistent OCD. Activa benytter Deeb Brain Stimulation terapi og er reversibel modsat for eksempel neurokirurgi.

Deep Brain Stimulation (DBS) har været anvendt til parkinson patienter i længere tid. 

Så der er håb forude hvis Lægemiddelstyrelsen og Sundhedsstyrelsen i Danmark også vil godkende denne behandling 

 

Medtronic today announced that the United States Food and Drug Administration (FDA) has designated Activa(R) 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). 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."

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.”

About Activa® Therapy

Approximately 30,000 implants of Medtronic’s Activa Therapy have been conducted worldwide for the three most common movement disorders:  Parkinson’s disease, essential tremor, and dystonia (also available under an HDE). 

Medtronic is currently conducting a pivotal clinical trial in the U.S. for the Interceptä 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 http://www.medtronic.com/activa/physician/activa.html.

Kilde: Medtronic 28. march 2005

Læs mere om Deep Brain Stimulation på Cleveland Clinic’ meget informative hjemmeside.