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www.fdanews.com/articles/70378-medtronic-s-activa-dbs-receives-hud-designation-for-ocd

Medtronic's Activa DBS Receives HUD Designation for OCD

March 28, 2005

Medtronic has announced that the FDA designated Activa Deep Brain Stimulation (DBS) Therapy as a humanitarian use device for the treatment of chronic, treatment-resistant obsessive compulsive disorder as an alternative to anterior capsulotomy, a form of destructive, irreversible neurosurgery.

This FDA designation may make the use of Medtronic's 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.

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).