So many aspects of the AbioCor Implantable Replacement Heart are astonishingly groundbreaking that one could easily overlook its simple purpose: To extend and improve life for people with end-stage heart failure.

The device, developed and manufactured by Danvers, Mass.-based Abiomed Inc., has been implanted this year in five people who are taking part in the first phase of human trials. With further approval from the Food and Drug Administration, Abiomed could extend the trials to 15 patients.

Although other mechanical hearts have been developed and implanted in humans, the AbioCor is the first that can function without the user being permanently attached to a power source via skin-piercing wires or tubes. This advance -- along with the cheaper production costs of the AbioCor and expectations for it to eventually function trouble-free for five years -- propels the device beyond mere technological wonder to a medical product that patients and doctors are likely to use.

Laman Gray, the cardiothoracic surgeon who implanted the AbioCor in the first two trial patients at Jewish Hospital, Louisville, Ky., says the step AbioCor has taken is "huge."

"We've demonstrated that we can implant an artificial heart and have a good quality of life."

According to Gray, about 100,000 people in the United States are living the "miserable lives" of end-stage heart failure, meaning the heart's deterioration is beyond the help of medicine and other treatments. Some are eligible for heart transplants -- if they are lucky enough to receive one of the 2,000 annual donations -- but some are not transplant candidates for a variety of reasons. It is this population that is expected to be the AbioCor market.

If the trials and technical refinements continue to go well, Abiomed expects to have AbioCor on the market by 2003, available to a limited population of patients.

The current AbioCor version can operate optimally at least 16 months, says Edward Berger, vice president for strategic policy and planning for Abiomed. Berger says the company is working on the goal of a five-year model because at that point, use of the heart becomes "productive" in terms of what it would cost to implant and the intensity of the surgery and recovery process. Also, the current model's size limits the likelihood that it would fit women or young adults, but the company plans further downsizing. Gray, who has been involved in the technical development of the AbioCor, says it would be fairly easy to downsize by 30%, and that size would fit nearly all patients.

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