Profile: Heartware, Inc. manufactures implantable left ventricular assist devices for the treatment of heart failure. The Heartware® left ventricular assist system is a small implantable centrifugal blood pump called the Hvad™ pump. The pump is designed to draw blood from the apex of the left ventricle and to propel it through an outflow graft connected to the patient™s ascending aorta. The device is capable of generating up to 10 liters per minute of blood flow. The Heartware™ controller is designed to provide control signals to drive the pump and also to provide feedback & alarms to the patient regarding the operation of the device. The Heartware™ AC adapter uses power from an electrical outlet to power the controller.

FDA Registration Number: 3007042319