FDA approves humanitarian device exemption for deep brain stimulator

Feb 20 2009

The U.S. Food and Drug Administration has 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).

The U.S. Food and Drug Administration today 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).

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 United States. To receive approval, a company must demonstrate the safety and probable benefit of the device.

"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," said Daniel Schultz, M.D., director, Center for Devices and Radiological Health. "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."

OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as handwashing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these actions provides only temporary relief, but not performing them markedly increases anxiety.

The approval of the human device exemption was based on a review of data from 26 patients with severe treatment resistant OCD who were treated with the device at four sites. On average, patients had a 40 percent reduction in their symptoms after 12 months of therapy. While all patients reported adverse events, the majority of these events ended after an adjustment was made in the amount of electrical stimulation.

Patients who require electroconvulsive shock therapy should not be implanted with the Reclaim device. Other patients who should not use the device include persons who will undergo magnetic resonance imaging (MRI) or deep tissue heat treatment known as diathermy.