FDA to Review Cyberonics VNS Therapy System in June 2004

OPEN MINDS, The Behavioral Health & Social Service Industry Analyst

Industry News

Cyberonics Inc. announced that it has been formally notified by the Food and Drug Administration (FDA) that a meeting of FDA's Neurological Devices Advisory Panel has been scheduled for June 15, 2004 to review Cyberonics' PMA-Supplement seeking approval to market the VNS Therapy System. According to Cyberonics, VNS is being proposed "as an adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that . . .