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|FDA Advisory Committee Votes in Favor of HeartWare® Ventricular Assist System as Bridge to Transplant for Patients With End-Stage Heart Failure|
FRAMINGHAM, Mass. and SYDNEY, April 25, 2012 /PRNewswire via COMTEX/ --HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration's (FDA) Circulatory System Devices Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.
"We are pleased with the panel's strong recommendation and would like to thank them for their thoughtful review of the data presented from the ADVANCE study," said Doug Godshall, CEO and President of HeartWare. "The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare® Ventricular Assist System in the United States, and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA. HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future."
The Advisory Committee's recommendation, while not binding, will be considered by the FDA in its review of the Premarket Approval (PMA) application that HeartWare submitted for the HeartWare® Ventricular Assist System in December 2010.
About HeartWare International
HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.
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SOURCE HeartWare International, Inc.