A Medical Device Daily

The FDA Thursday approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

Reclaim DBS Therapy, manufactured by Medtronic (Minneapolis), is intended to treat patients with severe OCD for whom more conservative therapy, such as pharmaceutical medication and psychotherapy, is not working.

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

Human device exemptions facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people per year in the U.S. To receive approval, a company must demonstrate the safety and probable benefit of the device.