Thoratec HeartMate II LVAS - P060040/S005
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: HeartMate II Left Ventricular Assist System (LVAS)
PMA Applicant: Thoratec Corporation
Address: Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Approval Date: January 20, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040S005a.pdf
What is it? The HeartMate II LVAS is a left ventricular assist device (LVAD) system, which is a device that helps the heart’s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes a pump implanted inside the patient’s body and components that remain outside the patient’s body. The pump controller and batteries are worn outside the patient’s body. The system also includes a battery charger/power supply and monitor that remain outside the body.
How does it work? The HeartMate II LVAS does not replace the natural function of the heart. Rather, it works along with the patient’s own heart to pump blood. In a healthy heart, the left ventricle pumps blood throughout the body. In a heart weakened by heart failure, the left ventricle is not strong enough to pump the blood sufficiently. The HeartMate II LVAS helps the heart by supporting the weak left ventricle and providing additional blood flow.
The HeartMate II pump is implanted below the heart with its entrance attached to the left ventricle and its exit connected to the aorta (the main blood vessel carrying blood from the heart to the body). Blood flows from the heart into the pump. A small electric motor in the pump drives a rotor (similar to a propeller) inside the pump that pushes the blood into the aorta and out to the body. A flexible tube passes through the patient’s skin and connects the implanted pump to a small controller worn outside the body. The controller is powered either by batteries or connected by means of a power supply to a standard household electrical power outlet.
When is it used? The HeartMate II is approved for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The use of this device in people with severe heart failure who are not candidates for heart transplantation is often called “destination therapy.”
The HeartMate II Left Ventricular Assist System (LVAS) is also approved as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. This is often referred to as “bridge-to-transplant.”
The HeartMate II LVAS is intended for use both inside and outside the hospital or for transportation of ventricular assist device (VAD) patients by way of ground ambulance, fixed wing aircraft, or helicopter.
What will it accomplish? A clinical trial of this device involved 200 randomized patients at 38 investigational centers. The clinical study showed that the HeartMate II LVAS was superior to the HeartMate XVE. Approximately 46% of the HeartMate II patients met the two-year primary endpoint (survival free from disabling stroke or device replacement or repair) while only 11% of the HeartMate XVE met the endpoint. Complications were comparable in the HeartMate II LVAS and HeartMate XVE groups.
As with any major surgery, there are risks involved with the surgery to implant the HeartMate II. There are also risks and complications with the device itself, such as death, bleeding, infections, and stroke.
When should it not be used? The HeartMate II should not be used in patients who cannot tolerate anticoagulation therapy (blood thinners) because these medicines are required to prevent blood clots from forming in the pump.
- FDA Press Release
- Summary of Safety and Effectiveness Data and labeling (patient handbook) for the destination therapy indication are available at:
- Other Resources:
- NIH MedlinePlus – Heart Failure http://www.nlm.nih.gov/medlineplus/heartfailure.html
- NIH MedlinePlus - Ventricular Assist Device http://www.nlm.nih.gov/medlineplus/ency/article/007268.htm
- Use of a Continuous-Flow Device in Patients Awaiting Heart Transplantation, New England Journal of Medicine (NEJM) 2007; 357:885-96