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 3 Left Ventricular Assist System (LVAS)
PMA Applicant: Thoratec Corporation
Address: 6035 Stoneridge Drive, Pleasanton, CA 94588
Approval Date: October 18, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/p160054s008a.pdf
What is it? The HeartMate 3 Left Ventricular Assist System (LVAS) is a heart pump system that helps the heart's left ventricle (the main pumping chamber of the heart) deliver blood to all parts of the body. The device is used for heart failure patients whose hearts are unable to pump blood effectively. The HeartMate 3 LVAS is made up of a blood pump that is implanted inside the patient's body and a pump controller with batteries that remains outside the patient's body.
The current application expands the system's indications for use to include long-term mechanical circulatory support (such as destination or permanent therapy) in patients with end-stage left-sided heart failure.
How does it work? The HeartMate 3 blood pump does not replace the natural function of the heart. Instead, 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 3 blood pump helps the heart by supporting the weak left ventricle and providing additional blood flow.
When is it used? The HeartMate 3 LVAS is used in patients with end-stage heart failure, when the natural heart is unable to maintain normal blood flows and/or pressure and cannot adequately provide oxygenated blood to the vital organs. It is intended to provide long-term (permanent) support to the heart.
What will it accomplish? The device will increase blood flow enough to protect the heart and other parts of the body when a patient requires long-term left heart support.
A clinical study of 366 patients compared survival of patients using the HeartMate 3 LVAS to those using the HeartMate II LVAS (currently available from the same manufacturer). The study showed that 77.9% of the HeartMate 3 patients, as compared to 56.4% of the HeartMate II patients, survived to 2 years without a disabling stroke and without the need to replace the pump. About 1.6% of the HeartMate 3 patients needed the pump replaced within 2 years, compared to about 12.2% of the HeartMate II patients.
As with any major surgery, there are risks involved with the surgery to implant the HeartMate 3 blood pump. 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 3 blood pump should not be used in patients who cannot tolerate, or who are allergic to, anticoagulation therapy (blood thinners) because these medicines are required to prevent blood clots from forming in the pump.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data (SSED) and labeling are available online.