FDA Clears HeartWare Ventricular Assist Device

HeartWare VAS offers bridge to heart transplant

 

December 6, 2012

 

The HeartWare Ventricular Assist System (VAS) is designed as a bridge to cardiac transplantation. It is a device that helps deliver blood from the heart to the rest of the body. It is used in some patients who have end-stage heart failure and are waiting for a heart transplant. The system includes a pump implanted in the pericardium and a controller that controls the speed and function of the pump. The controller remains outside the patient’s body and is connected to the pump by a flexible tube that passes through the patient’s skin. The controller is powered either by batteries or a power supply that can be connected to a standard electrical power outlet.

The system works with the patient’s own heart to pump blood. In a healthy heart, the lower chamber (left ventricle) pumps blood through the body. In a heart weakened by heart failure, the left ventricle may not be strong enough to pump the blood sufficiently. The HeartWare VAS helps the heart by supporting the weak left ventricle and providing additional blood flow.

Blood flows from the left ventricle into the pump through the pump inlet. The pump then moves blood into the aorta. This is accomplished by the rotation of the pump's impeller, which speeds up the blood flow and also causes a difference in pressure between the pump inlet and outlet.

The HeartWare VAS should not be used in patients who cannot tolerate blood thinners (anticoagulation therapy) because these medications are required to prevent blood clots from forming in the pump.

The FDA set expiration dating for this device at 25 months for the implant kit, accessories and surgical tools of the system, and 12 months for the controller and battery pack.

The U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the HeartWare Ventricular Assist System (VAS) in November 2012.

For more information: www.heartware.com