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Landmark clinical trial at 22 medical centers finds implanted heart pumps lengthen and improve lives of terminally ill heart failure patients

icant for patients with the device one year after implantation.

Based on the results, the FDA has allowed Thoratec to offer the HeartMate VE to six surviving patients in the medical management arm of the trial. To date, three of these patients have chosen to have the device implanted. The agency also has allowed the company to include an additional 30 patients in the trial.

"The REMATCH data proved to be so significant that Thoratec has submitted it to the FDA to seek approval to make the HeartMate VE available as soon as possible to congestive heart patients who are not eligible for cardiac transplantation," says D. Keith Grossman, president and CEO of Thoratec. "Thoratec is very appreciative of the collaboration among NHLBI, Columbia University, Dr. Rose and each of the investigators that has resulted in the realization of a goal the entire circulatory support industry has been striving toward for decades."

The researchers chose HeartMate VE because it has a textured surface that lowers the probability of clot formation even in the absence of anticoagulant, or clot-preventing, drugs. Thoratec, which provided the devices at no cost and paid for some medical care for the patients, also was willing to put its device through a rigorous randomized trial.

The investigators acknowledge that more research needs to be done to overcome some serious problems with the therapy, including infection and device failure.

"Heart failure affects an estimated 4.7 million Americans, with 550,000 new cases diagnosed each year," says Dr. Claude Lenfant, NHLBI director. "This compelling study shows that even with a high rate of complications, a left ventricular assistance device can provide a significantly longer and better quality of life in extremely ill heart failure patients for whom no other meaningful therapy is available."

With the data from the trial, the investigators are now comparing the cost of implanting the device with the
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Contact: Annie Bayne
as862@columbia.edu
Columbia University Medical Center
15-Nov-2001


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