FDA approves testing first implantable heart in nation

Mass. company to study device in five patients at five medical centers


PHILADELPHIA - The government has given the go-ahead to a Massachusetts company to try its artificial heart in humans.

Abiomed Inc. said yesterday it had received Food and Drug Administration approval to test AbioCor - the first totally implantable artificial heart - in five patients at five medical centers around the nation.

The first device likely will be implanted during the first half of this year, said Edward Berger, the company's vice president for government and external relations.

If things go well with the first patients, the trial will expand to include another 25 or so, he said.

After that, the company could seek full approval of the product.

The government began an initiative to produce an artificial heart in the 1960s. But earlier efforts were plagued by problems with infection, blood clots and bleeding.

Patients who got the Jarvik-7 artificial heart - the device that retired dentist Barney Clark received to great fanfare in 1982 - were tethered to a machine the size of a small refrigerator that greatly impaired quality of life. The FDA recalled that device in 1990.

The AbioCor - the name is a combination of the company name and the Latin word for heart - weighs about 2 pounds and is the size of a large grapefruit. It is powered by both internal and external batteries.

The internal battery is continually recharged from an external console or from a battery pack patients will wear around the waist. The electrical transmission is across, but not piercing, the skin. This reduces the chances of infection, an advantage over other devices available.

The internal battery can run the heart by itself for up to half an hour.

"Today, in my opinion, people need to more than stay alive," said Abiomed president David Lederman. "People need to have a reasonable quality of life. It's not only quantity of life."

Abiomed bought its primary competitor, a heart developed by researchers at Pennsylvania State University, last year. That product is still in development.

While doctors greeted the news of AbioCor's trial with optimism, their enthusiasm was tempered by previous setbacks. And, they said, the artificial heart - for all its science fiction appeal - has competition now. Smaller devices also in development that help or replace damaged ventricles may not be as appealing, but they're all most people need, doctors said.

Still, those devices won't be enough for everybody. So many people in this country have heart failure - up to 600,000 new patients are diagnosed each year - that even if only 10 percent or 15 percent of them need a whole heart, that's still a lot. Abiomed estimates the potential market for its artificial heart at about 100,000 a year.

At just 2,000 a year, the current number of transplants using cadaver hearts barely makes a dent in the need for new organs.

"One of the things we've learned with time is that heart disease has a spectrum just like cancer and every other disease," said Dr. O. H. "Bud" Frazier, a Texas Heart Institute surgeon who has been working on artificial heart development since the 1960s and will be involved in the AbioCor trial.

For most patients, he said, ventricular assist devices will probably be enough. The artificial heart will be most useful for patients whose hearts are suddenly destroyed by heart attacks.

Frazier has implanted the AbioCor heart in more than 100 calves without drawbacks, he said.

The initial patients will be very sick people - those who have more than a 70 percent chance of dying within a month. They must be ineligible for a transplant. And they must have big, barrel chests because the device is too large - 4 inches in diameter, about an inch bigger than an undiseased heart - for many people. Doctors will take a CAT scan of a potential patient, then use a computer to simulate placement of the artificial heart.

The goal of the trial is six-month survival, Berger said from Abiomed's offices in Danvers, Mass. The device has proven reliable for five years, he said.

But patients need to understand something about devices, said Dr. Satoshi Furukawa, a transplant surgeon at Temple University Hospital who frequently uses ventricular assistant devices and is involved in a trial to use one of those machines as an alternative to transplant.

"All machines will break," he said.

Officials and doctors involved in the research said the first patient is likely to come at Texas Heart Institute in Houston or Jewish Hospital Heart and Lung Institute in Louisville, Ky., the institutions that have the most experience with the device.

Other sites include Hahnemann University Hospital in Philadelphia, Brigham and Women's Hospital, which is teamed with Massachusetts General Hospital in Boston, and UCLA Medical Center, Los Angeles.

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