HeartWare Ventricular Assist System Receives FDA Approval as Bridge to Heart Transplantation (VIDEO)

November 21st, 2012 Wouter Stomp Cardiac Surgery, Cardiology

HeartWare, an Australian and Framingham, Massachusetts developer of ventricular assist devices, has received FDA approval for its HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. Key features of the device are its small size and lack of mechanical bearings.

The pump is small enough to be implanted in the pericardial space, directly adjacent to the heart, avoiding the necessity of creating a pump pocket with its attendant infection risks, as well as simplifying the surgical insertion. The single moving part of the pump, the impeller, is suspended within the pump housing through a combination of passive magnets and hydrodynamic thrust bearings, eliminating wear while spinning at rates between 2,400 and 3,200 revolutions per minute.

From HeartWare:

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 follows on positive results of the ADVANCE trial, which showed non-inferiority compared to other ventricular assist devices in end-stage heart failure patients. Additionally, in efforts to broaden the clinical indications, HeartWare has completed enrollment of a destination therapy study last May, but results will only be available when the two-year primary endpoint follow-up period has been reached. Commercial roll-out of the HeartWare System will start with the 50 U.S. hospitals that participated in HeartWare’s clinical studies, after which additional hospitals will follow.