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HeartWare Gets FDA Panel Date For HVAD Heart Failure Implant

Advisory panel review April 25 could pave the way for PMA approval this year as a bridge to heart transplant.

FDA’s Circulatory System Devices Panel will review HeartWare International Inc.’s miniature left ventricular assist system for use as a bridge to transplant in end-stage heart failure patients on April 25, the firm announced Feb. 14.

The HeartWare system incorporates the firm’s HVAD full-output, continuous flow, centrifugal blood pump. The miniature pump is designed to be implanted adjacent to the heart, avoiding the abdominal surgery generally...

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