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Cardiac Medical Devices
U.S. FDA approves first totally implanted permanent artificial heart for humanitarian uses
October 5th, 2006
The U.S. Food and Drug Administration recently approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act. The AbioCor Implantable Replacement Heart, made by Abiomed, Inc., is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention. In clinical studies, this product was shown to prolong the life and improve the quality of life for critically ill patients. "This device represents a significant advance in...
Source: Blood Weekly (2006-10-05)
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