Reuters: Regulatory News: RPT-US FDA advisers back Heartware blood pump device

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RPT-US FDA advisers back Heartware blood pump device Apr 25th 2012, 22:32 April 25 | Wed Apr 25, 2012 6:32pm EDT April 25 (Reuters) - HeartWare International Inc won a U.S. advisory panel's support on Wednesday for its most important product: a blood pump that helps people with severe heart failure. A panel of outside experts to the Food and Drug Administration voted 9-2 to recommend approval of the mechanical heart-assist device, called the HeartWare ventricular assist device (HVAD). HeartWare shares were halted pending the panel outcome. The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected later.

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