HeartMate 3™ Left Ventricular Assist System - P160054
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
PMA Applicant: Thoratec Corporation
Address: 6035 Stoneridge Drive, Pleasanton, CA 94588
Approval Date: August 23, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160054a.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.
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 so that it cannot adequately provide oxygenated blood to the vital organs. It is intended to provide short-term support to the heart (for example, to help the patient's own heart to recover or to support the patient until heart transplantation).
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 short-term left heart support.
A clinical study of 294 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 86% of the HeartMate 3, as compared to 77% of the HeartMate II, patients, survived to 6 months without a disabling stroke and without the need to replace the pump. No HeartMate 3 patients experienced suspected pump thrombosis (clotted pumps) at 6 months post implantation, while 10% of the HeartMate II patients did. However, more HeartMate 3 patients (10%) had a serious driveline (the line connecting the blood pump and the external controller) infection than the HeartMate II patients (4%).
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: The Summary of Safety and Effectiveness Data and labeling are available online.