HeartWare Device Has 9.2 Thrombosis Rate In Study
New data presented at the International Society of Heart and Lung Transplantation in San Diego suggested that patients implanted with a mechanical heart-assistance device made by HeartWare International Inc. have a 9.2 percent chance of developing a potentially life-threatening blood clot each year. The device, known as HVAD, is approved in Europe and is awaiting approval in the United States to keep patients alive while they wait for a heart transplant.
The unexpectedly high percentage was determined by a 250-person trial, in which 16 patients had pump-related blood clots. Eleven of those patients had to have the device replaced. The 9.2 percentage surprised physicians, who estimated the rate of blood clots to be around 3 percent.
In Heartwareâ€™s analysis of the data, the company said it found that those who took 325 milligrams of aspirin a dayâ€”rather than the previously recommended dosage of about 81 milligrams a dayâ€”had fewer blood clots. As a result, the company recently changed the protocol for its clinical trials to raise the aspirin dose to 325 milligrams. The company also plans to add a more textured surface to the pump, which they say will reduce the rate of blood clots.
Still, concerns about pump-related thrombosis may deter enrollment in the new clinical study. HeartWare’s shares have fallen 18 percent from their year high of $99.10 on January 13, after data on blood clots began to surface.
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