ARLINGTON, Va., Nov. 14, 2002 – The government has approved the HeartMate heart assist pump as a permanent implant for patients with severe heart failure.

The Food and Drug Administration (FDA) extended the use of the ventricular assist device, which had previously been approved only as a bridge to transplant.

The action makes HeartMate pumps available for about 20,000 to 30,000 people in the United States who are terminally ill but do not qualify for a heart transplant.

The manufacturer of the HeartMate, Thoratec, sought the FDA approval following a joint study with the National Institutes of Health of 129 patients with end-stage congestive heart failure.

Almost twice as many HeartMate patients survived the first year of the study compared with patients who received only drugs.

But there was a risk of complications from the surgery to implant the pump. One-third of patients required a second operation to stop bleeding, 41 percent developed a post-operative infection, and 10 percent suffered a stroke.

As a condition of the approval, the FDA is requiring a follow-up study to assess the safety and effectiveness of the pump's long-term use.