FDA APPROVES HEART ASSIST PUMP FOR PERMANENT USE

The Food and Drug Administration today approved a heart assist pump to be implanted permanently in certain terminally ill patients who are not eligible for heart transplant.

The device, called HeartMate, is a left ventricular assist device (LVAD) made by Thoratec Corporation, of Pleasonton, Calif. It assists weakly beating hearts by taking over the work of the heart's main pumping chamber, the left ventricle.

The HeartMate was previously approved solely as a bridge to transplant for patients eligible for heart transplants and waiting for an available heart.

Today's approval expands the availability of HeartMate to certain people with severe end-stage congestive heart failure who are not eligible for heart transplants.

"Heart technology is developing rapidly and holds great promise for the future," said Deputy FDA Commissioner Lester M. Crawford. "LVAD devices like the one approved today can add months to the lives of terminally ill heart patients. In the future, these devices may be able to extend life even longer and ultimately may have a major impact on the treatment of heart failure."

FDA approved the device for expanded use based on the results of a randomized clinical trial conducted by Thoratec in cooperation with the National Institutes of Health and on the recommendation of the Circulatory System Devices Panel of FDA's Medical Devices Advisory Committee.

The clinical trial enrolled 129 patients with end-stage congestive heart failure. Sixty eight received the HeartMate and 61 continued to receive the best drug treatment available.

The study showed that treatment with HeartMate doubled survival at one year compared to drug treatment. At one year, the survival rate was 50 percent for those who had the device implanted, compared to 28 percent for those who received drug therapy. After two years, the estimated probability of survival for HeartMate recipients was 27 percent, compared to 10 percent for those on drug therapy.

However, the increased survival rate came at a price: Implanting the device requires major surgery for already seriously ill people, and many patients experienced bleeding that required re-operation (32%), infection (41%), or stroke (10%).

Because of the serious side effects associated with the device, and the small population in which it was studied, use of the device will be limited to certain very sick patients who have severe end-stage congestive heart failure and are not eligible for a heart transplant. An estimated 20,000 to 30,000 people in the United States may fall in this category.

FDA is also requiring Thoratec to conduct a post-approval study to assess the device's long term safety and effectiveness for permanent use.

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