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: April 21, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060040a.pdf
What is it? The HeartMate II LVAS is a left ventricular assist device (LVAD) system; 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 through 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 taking over the function of the weak left ventricle and providing additional blood flow.
The HeartMate II pump is implanted below the heart with its inlet attached to the left ventricle and its outlet 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 via a power supply to standard household electrical power outlet.
When is it used? The HeartMate II Left Ventricular Assist System (LVAS) is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate II LVAS is intended for use both inside and outside the hospital or for transportation of ventricular assist device (VAD) patients via ground ambulance, fixed wing aircraft, or helicopter.
The HeartMate II LVAS is used in people with advanced (severe) heart failure who are candidates for heart transplantation but are expected to die before a donor heart becomes available. This is often called “bridge to transplant.”
What will it accomplish? A clinical trial showed that treatment with the HeartMate II LVAS kept the majority of patients alive long enough to receive a heart transplant. Fifty-seven percent (57%) of the patients were transplanted and another 17% of the patients survived for at least 180 days on the pump. Twenty percent (20%) of the patients died within 180 days of being implanted with the HeartMate II.
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, stroke, etc.
When should it not be used? The HeartMate II should not be used in patients who are not eligible for heart transplantation. It should also not be used in patients who cannot tolerate anticoagulation therapy (“blood thinners”) because these medications are required to prevent blood clots from forming in the pump.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060040