This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: HeartWare Ventricular Assist System
PMA Applicant: HeartWare, Inc.
Address: 14000 NW 57th Court
Miami Lakes, FL 33014
Approval Date: November 20, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100047a.pdf
What is it? The HeartWare Ventricular Assist System (VAS) 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 space around the heart (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.
How does it work? The HeartWare VAS 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 (where the blood enters the pump). The pump then moves blood into the main blood vessel carrying blood from the heart to the body (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 (where the blood exits the pump).
When is it used? Because there are a limited number of donor hearts available, the HeartWare VAS provides necessary cardiac support to the patient until a suitable heart is available. This is often called "bridge to transplantation." The HeartWare VAS is used as a bridge to transplantation in cardiac transplant candidates at risk of death from end-stage heart failure that is unmanageable by standard medical therapy. The device is designed for in-hospital and out-of-hospital settings, including transportation by fixed-wing aircraft or helicopter.
What will it accomplish? The HeartWare VAS will provide a bridge to transplantation. A clinical trial showed that treatment with the HeartWare VAS kept the majority of patients alive long enough to receive a heart transplant. In the study, 127 out of 140 patients (91%) either survived for at least 180 days on the pump (without having to get a new pump) or received a heart transplant within that time. Six (6) out of the 140 patients (4%) died within 180 days of being implanted with their first HeartWare VAS.
As with any major surgery, there are risks involved with the surgery to implant the HeartWare device. There are also risks and complications with the device itself, and these include death, stroke, infections, and bleeding.
When should it not be used? 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.
Additional information: Summary of Safety and Effectiveness and labeling are available online.