HeartWare International Inc Receives FDA Approval For HeartWare Ventricular Assist System As A Bridge To Heart Transplantation For Patients with Advanced Heart Failure

HeartWare International Inc 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.