FDA approves the first fully implantable artificial heart

After three decades of research and a difficult three-year human trial, one of the most complex and expensive devices in medical history won federal approval yesterday: the first fully implantable artificial heart.

The AbioCor Implantable Replacement Heart, made by the Danvers company Abiomed Inc., is a whirring 2-pound pump of plastic and titanium for patients whose hearts are so weak they can no longer keep blood flowing to vital organs.

The $250,000 device is not intended to keep patients alive indefinitely, but rather to extend the lives of dying people too sick to receive a transplant.

The Food and Drug Administration stopped short of granting full approval for the artificial heart, instead allowing it to be sold under a ``humanitarian use" exemption for products that help small numbers of patients with no alternatives. Abiomed can sell no more than 4,000 a year and must closely monitor patients who receive the devices.

The approval came more than five years after the first experimental AbioCor heart was tested in a human patient, a retired phone-company worker with a life expectancy of less than a month. He lived for five months.

So far, 14 patients have received experimental AbioCor hearts, with mixed results. The first, Robert Tools, became a minor celebrity in his hospital room in Louisville, Ky., going out for a cheesesteak sandwich with the city's mayor and taking a short fishing trip. Another patient lived 17 months and was healthy enough to check out of the hospital.

Others, however, did not survive the initial operation, which requires doctors to remove the heart's pumping chambers and stitch the device into place. Several patients, including Tools, suffered strokes after blood clots formed around certain parts of the artificial heart.

Unsure whether the device truly improved the quality of life of its recipients, a panel of FDA science advisers a year ago narrowly voted to deny the company's request to begin selling it. But after further discussion and analysis of the trial results, they approved the device yesterday, saying sick patients should have the right to decide whether to try the artificial heart.

``It's certainly not the end of the journey," said Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, who noted the agency's requirement for patient monitoring.

Abiomed says it will spend the next six to eight months training doctors to implant the artificial heart. Initially, it expects to begin implants at just five hospitals, but will eventually expand the procedure to 10. The first is likely to be Jewish Hospital in Louisville, where seven of the 14 artificial hearts in the trial were implanted. The company has letters of intent from Johns Hopkins Hospital in Maryland and Robert Wood Johnson University Hospital in New Jersey. It has not said what other hospitals will conduct artificial heart implants.

Dr. Gus Vlahakes, chief of cardiac surgery at Massachusetts General Hospital, trained to install the artificial heart in the clinical trial but did not find a patient that met the study criteria. He said the device will serve a ``very narrow niche" of patients, in part because newer devices, including partial heart pumps and sophisticated pacemakers, have emerged to help dysfunctional hearts.

Still, he said, he hopes Mass . General will become a center for implants.

The cost of the AbioCor heart -- likely the most expensive implanted medical device ever -- raises questions about who will pay for it. Abiomed has not issued any sales projections , but the numbers are likely to be far smaller than the 4,000 allowed.

Michael Minogue, chief executive of Abiomed, said the company has been talking to Medicare and insurers about covering the AbioCor for patients who qualify.

``These patients can cost an insurance company or the government in excess of $1 million in the last six months of their lives," he said.

The AbioCor is powered by a belt-mounted power pack that transmits energy to the device through the skin. It can be plugged into an electrical outlet to recharge. A battery implanted in the patient's belly can let the patient bathe and walk freely for short stretches, although some patients who received the trial artificial heart were so ill they never walked.

The device is the first success in a long line of attempts to replace the human heart. Most prominently, the Jarvik-7 in the early 1980s kept patients alive for up to 620 days, but they were tethered to a giant air compressor that powered the device.

A successor to the Jarvik heart is now used to keep patients alive while waiting for a transplant, but they cannot leave the hospital with it.

Dr. Rob Dowling, a heart surgeon at Louisville's Jewish Hospital who helped implant seven of the original 14 Abiomed hearts, said the company set a ``lofty goal" in trying to build a fully implantable artificial heart. With its combination of mechanical pump, computer sensors, and power source, he said, it easily ranks as the most complex medical device ever created.

``Whatever is in second I don't know," Dowling said, ``but it's a very distant second."

Stephen Heuser can be reached at sheuser@globe.com.