FRAMINGHAM, Mass. and SYDNEY, Feb. 14, 2012 /PRNewswire/ -- 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, announced today that a U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the Premarket Approval (PMA) application for the HeartWare ® Ventricular Assist System on April 25, 2012.
"Notification of the FDA advisory committee meeting represents continued progress toward our goal of obtaining U.S. approval of the HVAD ® System for patients with end-stage heart failure," stated Doug Godshall, President and Chief Executive Officer of HeartWare. "We look forward to discussing the efficacy and safety data for the HVAD Pump with the members of the panel and the FDA review team, and believe that these data underscore the potential utility of the HVAD System in improving treatment outcomes for end-stage heart failure patients."
HeartWare's PMA submission encompasses data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption (IDE) study designed to evaluate the HVAD System as a bridge to heart transplantation for patients with end-stage heart failure. Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010.About HeartWare International HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare ® Ventricular Assist System features the 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. HeartWare has received CE Marking for the HeartWare System in the European Union. The device is currently the subject of United States clinical trials for two indications: destination therapy and bridge-to-transplant under a continued access protocol. For additional information, please visit the Company's website at www.heartware.com.