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Partial Arftificial Heart Approved

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  • MONDAY, Oct. 18 (HealthDayNews) -- The U.S. Food and Drug Administration has approved a partial artificial heart designed to keep people alive in the hospital while they await a heart transplant.

    The device is intended as a "bridge to transplant" for people waiting for a heart transplant who don't respond to other treatments and are at risk of death from heart failure, the FDA said in a statement Monday.

    The product is a "pulsating bi-ventricular device" that is implanted into the chest to replace the patient's left and right ventricles -- the bottom half of the heart. Recipients are then connected by tubes from the heart through their chest wall to a large power-generating console, which operates and monitors the device.

    The heart is manufactured by Syncardia Systems Inc., of Tucson, Ariz. The company studied use of the artificial heart in 81 patients with severe heart failure at five medical centers in the United States. In the studies, 79 percent of the patients who received the heart remained alive long enough to receive a donor heart (an average of 79 days), the FDA said.

    Approximately 4,000 patients in the United States await heart transplants annually, but only 2,200 donor hearts typically become available. The FDA is requiring Syncardia Systems to conduct a post-approval study to monitor the device's performance in commercial use, the agency said.

    To learn more about the Syncardia product, visit the company's Web site.

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