FRAMINGHAM, Mass. 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.
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. The HeartWare System is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The HeartWare System is currently the leading ventricular assist device implanted in patients outside of the United States, having received CE Marking in the European Union in 2009, and Australian Therapeutic Goods Administration (TGA) approval in 2011. Today, more than 2,500 advanced heart failure patients globally have received the HVAD ® pump. "FDA approval marks the culmination of an extensive clinical effort and represents an exciting advance in the treatment of late-stage heart failure patients," said Doug Godshall, President and Chief Executive Officer of HeartWare. "We wish to extend our most sincere thanks to the patients, and to their families, for participating in the study of this innovative device, and we also are grateful to each of the nurses, coordinators, surgeons and cardiologists who provided care to those patients."