April 26th, 2012
FDA Advisory Panel Gives Green Light to HeartWare Ventricular Assist System
Larry Husten, PHD
The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted 8-3 that the device […]
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