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FDA Approves Implant for Depression Treatment

Posted by Wildflower on February 3, 2005, at 10:38:52

Pacemaker-like device delivers electrical impulses to brain
Updated: 7:52 p.m. ET Feb. 2, 2005

LOS ANGELES - U.S. regulators have given conditional approval to Cyberonics Inc.’s application to market an implanted device to treat depression, the company said Wednesday.

The VNS Therapy System is a pacemaker-like device that delivers electrical impulses to the brain. Cyberonics already sells the implant for reducing seizures from epilepsy.

The FDA said approval was conditional on final labeling, protocols for a post-marketing dosing study and patient registry as well as compliance with quality system regulations and resolution of any outstanding monitoring issues.


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poster:Wildflower thread:452409
URL: http://www.dr-bob.org/babble/20050202/msgs/452409.html