Patients may soon be able to access a new form of treatment for obsessive-compulsive disorder (OCD), with the recent approval by the FDA of 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 OCD.

The Reclaim system uses a small electrical generator known as a pulse generator to create electrical stimulation that blocks abnormal nerve signals. The 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 (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 United States. To receive approval, a company must demonstrate the safety and probable benefit of the device. The device will provide relief, but it won't cure OCD, says Daniel Schultz, director, Center for Devices and Radiological Health.

Approval came after reviewing data from 26 patients with severe treatment-resistant OCD. On average, patients had a 40% reduction in their symptoms after 12 months of therapy. While all patients reported adverse events, the majority of these events ended after electrical stimulation amounts were adjusted.