FDA Issues Exemption for Device That Treats OCD
Reclaim system uses electrical stimulation to block abnormal nerve signals
FRIDAY, Feb. 20 (HealthDay News) -- The U.S. Food and Drug Administration has issued a human device exemption for a system that uses electrical therapy in the brain to suppress severe obsessive-compulsive disorder (OCD) symptoms, according to a release issued by the agency Feb. 19.
The Reclaim system uses a battery-powered device that is implanted near the abdomen or collar bone and connected to electrodes implanted in the brain. It creates electrical stimulation that blocks abnormal nerve signals in the brain.
According to the FDA, human device exemptions facilitate the development of products for treating or diagnosing diseases and conditions that affect fewer than 4,000 people in the United States annually. The FDA based its approval of the human device exemption for the Reclaim system on a review of data from 26 patients with severe treatment-resistant OCD who were treated with the device. On average, they had a 40 percent reduction in their symptoms after 12 months of therapy.
"Deep brain stimulation using the Reclaim system may provide some relief to certain patients with severe obsessive compulsive disorder who have not responded to conventional therapy," Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said in a release. "However, Reclaim is not a cure for OCD. Individual results will vary and patients implanted with the device are likely to continue to have some mild to moderate impairment in functioning and continue to require medications."