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FDA approves HeartWare ventricular assist system IDE supplement application

The US Food and Drug Administration (FDA) has approved HeartWare International's investigational device exemption (IDE) supplement application under a continued access protocol (CAP) to enroll a fourth allotment, of 54 additional patients, in its Advance bridge-to-transplant clinical trial .

HeartWare said, in three prior CAP allotments granted by FDA, 202 patients were enrolled between April 2010 and December 2011.

Advance trial is designed to assess the HeartWare ventricular assist system as a bridge to heart transplantation for patients with end-stage heart failure.

The HeartWare system features a HVAD pump, a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.

The company submitted a pre-market approval (PMA) application to the FDA seeking approval of the HeartWare System for the bridge-to-transplant indication in December 2010, and an FDA Circulatory System Devices Panel will review the PMA application on April 25, 2012.

The HeartWare system has also received CE mark and TGA approval.