FDA APPROVES 'TOTALLY IMPLANTED' PERMANENT ARTIFICIAL HEART
The FDA approved the first "totally implanted artificial heart" for patients with advanced heart failure, the agency announced Sept. 5.
The AbioCor Implantable Replacement Heart is made by Abiomed.
It is intended for patients with advanced heart failure in both pumping chambers of the heart who are ineligible for heart transplants due to advanced age or medical conditions. These conditions include very elevated pressure in the lungs, severe diabetes or kidney failure.
The artificial heart is intended for patients who are unlikely to live more than a month without intervention.
The FDA approved it under the humanitarian use device provisions of the Food, Drug and Cosmetic Act, as the number of patients affected is fewer than 4,000 a year.