The HeartMate II is the first compact heart assist device designed to support the weakened heart of a small-sized man or woman with heart failure who is at risk of dying while waiting for a heart transplant.
"The HeartMate II is an important advance in mechanical heart technology," says Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, in a news release. "Until now, some heart transplant candidates have been underserved due to the large size of previously approved heart assist devices."
How Heart Pumps Work
People with heart failure have weakened hearts that are no longer able to pump enough blood to meet the body's needs. Heart transplant is often the only treatment option for advanced disease, but it requires waiting for a suitable donor heart to become available.
Heart assist devices are mechanical pumps that are surgically implanted to help the heart's ventricle do its job of pumping blood to the rest of the body. These heart pumps can often buy valuable time while awaiting heart transplant.
But previously approved models were too large to be placed in the upper abdomen of some women and smaller-sized men.
The HeartMate II Left Ventricular Assist System uses a first-of-its kind continuous flow pump with a single moving part that reduces the size of the device to about 3 inches in length; it weighs about a pound.
An electrical cable that powers the heart pump passes through the patient's skin to an external controller worn on the waist that can be powered by an electrical outlet or batteries.
The device is set to pump blood to meet the individual's needs and sounds an alarm if it detects dangerous conditions or a possible malfunction.
The FDA based its approval on a clinical study of 126 heart failure patients at 26 transplant centers. More than half of those using the HeartMate II (57%) survived to a heart transplant, a rate that is comparable to that found with previously approved heart assist devices.
The manufacturer, Thoratec Corporation of Pleasanton, Calif., is required to conduct further study to evaluate the heart pump's post-approval performance.