February 19, 2009

FDA OKs deep brain stimulation for OCD

The U.S. Food and Drug Administration has approved a humanitarian exemption for the first implantable device to treat severe obsessive-compulsive disorder.

The FDA said the Reclaim DBS Therapy device, manufactured by Medtronic Inc., delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe OCD. The device is intended to treat patients for whom more conservative therapies, such as medication and psychotherapy, aren't working.

The Reclaim system uses a small electrical generator to create electrical stimulation that blocks abnormal nerve signals in the brain, the FDA said. The battery-powered device is implanted near the abdomen or the collar bone and connected to four electrodes implanted in the brain. Two device systems may be implanted to stimulate both sides of the brain or one device may be implanted with two lead outputs.

Officials said humanitarian exemptions facilitate the development of medical devices intended to treat or diagnose fewer than 4,000 people per year in the United States. Officials, however, cautioned the Reclaim device doesn't provide a cure and patients are likely to continue to have some mild to moderate impairment in functioning and continue to require medications.

OCD is an anxiety disorder characterized by recurrent, unwanted thoughts or repetitive behaviors.