FDA Approves Artificial Heart for Heart Failure Patients

Candidates are critically ill patients who cannot undergo heart transplant

WEDNESDAY, Sept. 6 (HealthDay News) -- The U.S. Food and Drug Administration has approved the use of the first artificial heart that is totally implanted in patients. The AbioCor Implantable Replacement Heart, manufactured by Abiomed, Inc., of Danvers, Mass., is approved for use in patients with advanced heart failure involving both pumping chambers of the heart who cannot undergo heart transplant due to age or other factors.

The device consists of a two-pound mechanical heart, a power transfer coil, a controller and an internal battery, as well as two external batteries. One of the criteria to assess suitability for the device is whether or not the chest cavity can accommodate the device.

The approval, granted under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act, was based on a small clinical study of 14 patients in which it extended the life of several patients, including one who lived for an additional 10 months and another for 17 months.

"FDA recognizes that not all patients who are eligible will choose this option, but for many patients faced with death, the chance to have additional time with family and friends -- however limited -- is a chance they are willing to take," said the FDA's director of the Center for Devices and Radiological Health Daniel Schultz, M.D., in a statement.

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