Deep brain stimulation device could help treatment of obsessive
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,
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.