HeartWare Receives FDA Approval for HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation for Patients with Advanced Heart Failure

HeartWare Receives FDA Approval for HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation for Patients with Advanced Heart Failure PR Newswire FRAMINGHAM, Massachusetts and SYDNEY, Nov. 20, 2012 – First full-support, miniaturized ventricular assist device approved in U.S. designed to be placed in the pericardial space – – HeartWare Management to Host Investor Conference Call Today at 3:00 pm ET – FRAMINGHAM, Massachusetts and SYDNEY, Nov. 20, 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, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. http://photos.prnewswire.com/prnh/20121120/LA17073 The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HVAD pump, with sintered inflow cannula, weighs approximately 5 ounces and displaces a volume of approximately 50 milliliters.