The use of fully implanted artificial hearts for patients with advanced heart failure was approved for use Wednesday by the U.S. Food and Drug Administration.
The device approved is the AbioCor Implantable Replacement Heart, made by Abiomed, Inc., of Danvers, Mass.
The system consists of a 2-pound mechanical heart that replaces the diseased heart, a power transfer coil that powers the system and recharges the internal battery from the outside; and a controller and an internal battery, which are implanted in the patient's abdomen.
The device is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention.
An Abiomed study of 14 people showed the device is safe and has likely benefit for people with severe heart failure whose death is imminent and for whom no alternative treatments are available. In some cases, the device extended survival by several months.
Copyright 2006 by United Press International