CorCap controversy headed for panel
This article was originally published in The Gray Sheet
Executive Summary
Acorn Cardiovascular's CorCap cardiac support device has the dubious distinction of being one of two devices referred to FDA's Medical Devices Dispute Resolution Panel in 2006 after three years of inactivity from the independent review body. The panel will convene Dec. 15 to review the science behind the company's PMA application for the polyester mesh wrap, intended to provide ventricular support in patients with symptomatic heart failure despite optimal medical management, Acorn's Oct. 17 release indicates. FDA's Circulatory System Devices Panel voted 9-4 against approval in June 2005 (1"The Gray Sheet" June 27, 2005, p. 3). Cardima's request for a hearing on its Revelation Tx ablation microcatheter system was granted in July (2"The Gray Sheet" July 24, 2006, p. 6)...
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