Cyberonics VNS Therapy for depression approved
This article was originally published in The Gray Sheet
Executive Summary
FDA-mandated post-market surveillance includes 460-patient randomized dosing study and a 2,000-patient, five-year registry to facilitate patient selection, according to a Cyberonics release announcing PMA approval for the neuromodulation device. Conditions for the device carry over from the original FDA panel in June 2004, including a requirement that patients fail four or more antidepressant treatments. Both trials are larger in scope than those initially proposed by Cyberonics (1"The Gray Sheet" Feb. 07, 2005, p. 3)...