FDA panel OKs Thoratec heart-pump device

An FDA panel unanimously voted to support the approval of Thoratec Corp.'s HeartMate II, a heart-pump device intended for heart-failure patients awaiting transplants, despite a failure to reach its preset goal. The panel said the agency must require a post-market study, and the device's warning label must state the product should not be given to patients who cannot tolerate anticlotting drugs.

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