The FDA's Circulatory System Devices panel voted 9-2 Wednesday after the market close to recommend approval of the HeartWare ventricular assist system (VAS) as a bridge-to-transplantation (BTT) for patients with end-stage heart failure. Despite some concerns about safety, the panel decided the benefits outweigh the risks for the new device from HeartWare (Framingham, Massachusetts), which is implanted next to the heart. Read More
