Depression Device Approved

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Associated Press
Saturday, July 16, 2005

The government yesterday approved a new therapy for the severely depressed who have run out of treatment options: a pacemaker-like implant that sends tiny electric shocks to the brain.

The Food and Drug Administration's clearance opens Cyberonics Inc.'s vagus nerve stimulator, or VNS, as a potential treatment for an estimated 4 million Americans -- despite controversy over whether it really has been proven to work.

"These are patients pretty much at the end of the line in terms of what treatment options are available to them," said FDA medical device chief Daniel Schultz, who said he was persuaded by Cyberonics' research despite initial skepticism within his agency.

The pacemaker-like implant has been sold since 1997 to control intractable epilepsy, a much smaller market. A generator the size of a pocket watch is implanted into the chest. Wires snake up the neck to the vagus nerve, delivering tiny electric shocks into a region of the brain thought to play a role in mood.