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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: HeartMate® SNAP-VE LVAS (Sutures Not APplied-Vented Electric Left Ventricular Assist System)
Manufacturer: Thoratec Corporation
Address: 6035 Stoneridge Drive, Pleasanton, CA 94588
Approval Date: November 6, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p920014s016a.pdf
What is it? HeartMate SNAP-VE LVAS is the first left ventricular assist device (LVAD) approved for long term implant. LVADs are devices that help the heart’s left ventricle, the main pumping chamber of the heart, deliver blood to the rest of the body. HeartMate has been approved since 1998 as a short-term treatment for patients waiting for heart transplants. For the first time, FDA has also approved this LVAD as a long-term treatment for severe heart failure in patients who are not candidates for heart transplants.
The HeartMate system includes an implanted pump and a controller and power supply worn outside the body.
How does it work? The HeartMate does not replace the heart. Rather, it works along with the patient’s own heart to pump blood. In a healthy heart, the left ventricle pumps blood through the body. In a heart weakened by heart failure, the left ventricle is not strong enough to pump the blood sufficiently. HeartMate helps the heart by providing additional strength to the pumping action.
The HeartMate pump is implanted in the abdomen and attached to both the left ventricle and the aorta (the main blood vessel carrying blood from the heart to the body). Blood from the heart flows into the device. The HeartMate then pumps the blood through the aorta to the rest of the body. A flexible tube passes through the patient’s skin and connects the implanted pump to a small computer (the “controller”) worn outside the body. The controller is powered either by batteries or connected to an electrical power line.
When is it used? HeartMate SNAP-VE LVAS is used in people with advanced (severe) heart failure. In the past, it has been used as a short-term treatment (a bridge to heart transplant). It is now also approved for use in patients who are not eligible for heart transplants.
What will it accomplish? A clinical trial (the REMATCH* clinical trial) showed that treatment with HeartMate increased patients’ life expectancies compared to drug treatment. The study showed that treatment with HeartMate doubled the number of patients who survived for at least one year compared to the best available drug treatment. (After one year, about half of the patients treated with HeartMate were alive compared to about one quarter of patients treated with drug treatments). After two years, approximately one out of four HeartMate recipients was alive compared to one out of 10 of those on drug therapy.
As with any major surgery, there are risks involved with the surgery to implant the HeartMate. There are also risks and complications with the device itself, such as infections, bleeding, and stroke. In addition several patients in the REMATCH* clinical trial needed follow-up surgery to replace malfunctioning or failed blood pumps.
*Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure.
When should it not be used? The HeartMate SNAP-VE LVAS should be used as a permanent treatment only in patients who:
- have severe end stage congestive heart failure;
- are not eligible for heart transplants;
- have a body surface area (BSA) greater than 1.5 square meters. (BSA depends on height and weight. Very short or very thin people are not usually good candidates for the HeartMate pump because their BSA is too small).
Additional information: Summary of Safety and Effectiveness is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p920014s016