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FDA Panel Supports HeartWare VAD, Despite Trial Shortcomings

Benefits of HeartWare system, as well as the prospect of adding a competitive device to a market currently dominated by a single product, overshadow uncertainties from missing data, panelists vote.

Most members of an FDA advisory panel found the benefits of making HeartWare International Inc.’s left ventricular assist device available in the U.S. to overshadow the uncertainties that stem from a less-than-stellar clinical trial.

The Circulatory System Devices Advisory Panel voted 9-2 that the benefits outweigh the risks for the use of the HeartWare Ventricular Assist System as a bridge to heart transplant in...

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