Panel OKs implant to fight depression

Washington Post | June 16 2004

WASHINGTON - A surgical implant that stimulates the brain should get government approval to treat chronic depression, an expert panel of federal experts said Tuesday - marking the first time an implanted device has been recommended for the treatment of a psychiatric disorder.

Using a technique known as vagus nerve stimulation, the device uses electrodes implanted in the neck to activate brain regions that are believed to regulate mood.

The decision by an expert advisory panel of the Food and Drug Administration came after a day of clashing scientific opinions about whether the data submitted by the manufacturer were adequate for approval. Proponents of the device prevailed, citing the desperate need of patients with chronic depression that does not respond to existing treatments.

The verdict by the advisory panel came after FDA scientists and some panel members argued the data presented by the manufacturer to show the device works were not convincing.

The agency is not required to follow the guidance of its advisory committee but usually does.

The device has been used in the United States since 1997 to control epileptic seizures.

The implant involves connecting a wire to the left vagus nerve in the side of the neck.