Trial of Mechanical Heart to Begin in People

The developer of a mechanical heart designed as a permanent replacement has been granted permission by the U.S. Food and Drug Administration (FDA) to begin the first clinical trial at five medical centers involving five patients too sick for transplants.

Called the AbioCor, the device weighs about two pounds and is about the size of a grapefruit. The replacement heart is inserted in the body with a battery that can be recharged through the skin. The device is intended for end-stage heart failure patients who are at risk of imminent death, cannot have a transplant, and cannot be helped by other available therapies. AbioCor was developed by Abiomed, Inc. (Danvers, MA, USA).

"Jewish Hospital is proud to continue being a part of ground-breaking research that will impact patients in this region and around the world,” said John Oldfather, P.D., vice president and administrator of the Jewish Hospital Heart and Lung Institute (Louisville, KY, USA), which was involved in the preclinical testing program and is one of the five U.S. medical centers where AbioCor will be implanted.



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