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Old 06-11-04, 08:29 PM
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Panel to Review Electric Device for Depression

Fri Jun 11,11:07 AM ET

By Susan Heavey

WASHINGTON (Reuters) - Chronically depressed U.S. adults who find no relief with drugs or psychotherapy could soon be able to try an implanted pacemaker-like device that sends electrical pulses to the brain.


The stopwatch-sized device by Cyberonics, is surgically inserted in the chest, where a wire runs up to wrap around a nerve in the neck.


On Tuesday a U.S. Food and Drug Administration (news - web sites) panel of outside experts will meet to discuss whether to recommend the agency approve the device -- already cleared for epilepsy -- for patients with stubborn depression.


Analysts say FDA approval of VNS Therapy for depression is key for future growth of the company, which posted a $1.25 million loss last quarter. The agency usually follows the advice of its outside experts.


Alexander Arrow, an analyst for Lazard Freres, said approval would boost the company's sales market "at least threefold." While some of the company's statistical data is weak, the panel is likely to recommend approval, Arrow said.


Shares of Houston, Texas-based Cyberonics closed up 66 cents, or 3.72 percent, to $18.39 on the Nasdaq on Thursday, a day after hitting a 14-month low.


Cyberonics officials declined to comment before the FDA panel meeting, but have said depression is an "enormous market opportunity."


VNS Therapy, which is already approved for depression in Europe and Canada, could reach $1 billion in U.S. sales in 2010, company officials said last year.


BRAIN STIMULATION


Shock treatments known as electroconvulsive therapy, or ECT, have long been used to treat severe depression.


While some critics charge the treatment is inhumane and unsafe, researchers say modern electrical stimulation has improved over the last 70 years. It can be the only hope for desperate patients who do not benefit from antidepressants or counseling, they say.


Unlike traditional shock treatments that provide overall brain stimulation, VNS Therapy targets one particular nerve -- the vagus nerve.


Continuous mild electronic pulses to the nerve send signals to the brain that Cyberonics says can lift mood.


"It is a very different sort of treatment than ECT," Sarah Lisanby, a Columbia University psychiatry professor who worked on early depression trials of VNS Therapy, said.


In one study, 12 percent of 124 patients said their symptoms improved by half or more after one year. Another study showed between 21 percent and 30 percent of 205 patients improved a year later.


Nearly 10 percent of Americans suffer from depression, which is the leading cause of disability, according to the National Institutes of Health (news - web sites).


Lisanby said about one-third of depressed patients do not improve with medication. With few other options, the most depressed have a higher risk of suicide, she said.


"When treatment after treatment has failed to improve your condition and when your doctor doesn't know where to turn next ... (it) can contribute to people's sense of hopelessness," Lisanby said.
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