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ROCKVILLE, Md., Oct 18, 2004 (United Press International via COMTEX) -- The U.S. Food and Drug Administration has approved a partial artificial heart that can keep people alive while they await a donor organ for transplant.
The pulsating bi-ventricular device made by Syncardia Systems Inc. of Tucson replaces a patient's left and right ventricles -- the bottom half of the heart. The device also is connected to a large, power-generating console.
The "bridge to transplant" will be used for patients at risk of imminent death who are awaiting a transplant organ.
Clinical trials on the device included 81 such patients with severe bi-ventricular heart failure at five U.S. medical centers. Studies showed 79 percent of patients implanted with the device remained alive long enough to receive a donor heart.
About 4,000 people in the United States wait for a heart transplant each year as only 2,200 donor hearts usually become available. About 100 of the patients now on the waiting list have non-reversible bi-ventricular failure and could be candidates for the new artificial heart.
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Page last updated: 19 October 2004 |