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Biotech / Medical : Cyberonics (cybx) epilepsy therapy recommonded

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From: Skywatcher10/20/2004 2:07:50 AM
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Cyberonics gets FDA OK for VNS Therapy trial (Corrects) By Heather Wilson
HELLLLLLOOOOOOOOOOOOOOO!!!!!!!!!!!
SAN FRANCISCO (CBS.MW) -- Cyberonics Inc. (CYBX: news, chart, profile) said late Tuesday that it was given U.S. Food and Drug Administration approval to make its VNS Therapy available to up to 100 patients with life-threatening treatment-resistant depression in a clinical trial. The FDA's Treatment Investigational Device Exemption allows a device to be administered to extremely ill patients when there is nothing comparable available. The VNS Therapy system delivers intermittent mild electrical pulses to the vagus nerve and was approved for the treatment of epilespy in 1997. Cyberonics is seeking approval to market the device for life-threatening treatment-resistant depression in the U.S. (Corrects to reflect what the device was approved for)
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