Panel suggests neck implant for depression

http://www.indystar.com/articles/5/155194-4335-052.html

Some patients need radical treatments after existing methods fail, experts argue.

By Shankar Vedantam
The Washington Post

June 16, 2004
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WASHINGTON -- A surgical implant that stimulates the brain should get government approval to treat chronic depression, a 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 who do not respond to existing treatments.


"We lost four of these individuals in the last 2{1frac2} hours," said A. John Rush, a psychiatrist at the University of Texas Southwestern Medical Center at Dallas, basing that figure on the high suicide rate among patients with resistant depression.


The device has been used in the United States since 1997 to control epileptic seizures. The manufacturer, Cyberonics Inc. of Houston, hopes to expand its market. About 15 percent to 25 percent of the 19 million Americans with depression may not respond to available treatments, Rush said.


The implant involves connecting a wire to the left vagus nerve in the side of the neck; a battery is implanted high in the left chest or under the armpit, and the amount of current can be regulated externally. Typically, the implant sends a 30-second pulse of current followed by a five-minute pause 24 hours a day.

Karmen McGuffee of Garland, Texas, told the panel she had tried virtually every antidepressant drug on the market before getting the device. Improvement came within weeks, she said.

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