THURSDAY, Nov. 07, 2002 (HealthDayNews) --
A pump that permanently assists weakly beating hearts in terminally ill patients who aren't eligible for heart transplants has been approved by the U.S. Food and Drug Administration.
The HeartMate, made by Thoratec Corp of Pleasonton, Calif., is designed to take over the work of the heart's main pumping chamber, the left ventricle. It had won previous FDA approval as a stopgap for patients awaiting heart transplants. The expanded approval allows for its permanent implantation in people with severe congestive heart failure.
A company-sponsored clinical trial involving 129 people found that 50 percent of patients with the device survived at least one year, compared with 28 percent of those who received the best drug therapy available. After two years, 27 percent of HeartMate patients survived, compared with 10 percent of those on drug therapy.
Some 20,000 to 30,000 people in the United States may be eligible for the device, the FDA says. Serious side effects could include bleeding requiring additional surgery, infection, and stroke.
As a condition of approval, Thoratec will be required to study and provide data on the device's long-term safety and effectiveness, the FDA says.
Here is the FDA Talk Paper describing the product. For more information about congestive heart failure, visit the National Library of Medicine.
