updated 9/5/2006 8:33:46 PM ET 2006-09-06T00:33:46

A Massachusetts company received federal approval Tuesday to sell up to 4,000 artificial hearts a year, though the number of devices implanted annually is likely to be far smaller.

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The two-pound hearts would be used only in patients who are close to death and have no other treatment options.

The Food and Drug Administration granted Abiomed Inc. a humanitarian exemption allowing it to sell the devices, agency spokeswoman Susan Bro said. The actual number of the devices, called the AbioCor, to be implanted likely will be small — between just 25 and 50 a year, Bro said.

“We’re talking about a small group of end-stage patients, whose choice is between immediate death or new, innovative technology,” said Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health.

So far, the artificial heart has been tested in only 14 men. Two died from the operation, and another never regained consciousness. The rest survived only an average of five months, though notably one patient lived 10 months following surgery, and another 17 months. The latter patient, Tom Christerson, died in February 2003 after moving home.

The company said earlier that it would begin implanting the artificial hearts at five hospitals around the country once doctor training is complete. Unlike other permanent artificial hearts, including the Jarvik-7 implanted in Barney Clark in 1982, the AbioCor is fully contained within the chest, with no outside wires.

“I think as the technology improves, it’s going to be a good option for people,” said Dr. Laman Gray, a University of Louisville surgeon who was part of a team that implanted the first AbioCor. That surgery was done at Jewish Hospital in Louisville, which is expected to be among the five hospitals offering the mechanical hearts to patients.

Device is too large for most women
Abiomed is targeting men — but not precluding women — with heart failure who are too sick for a heart transplant, have exhausted other options and are likely to die within a month. The current device is too large for about 90 percent of U.S. women and many men. The company is developing a smaller and longer-lasting version.

In 2005, an FDA panel of outside experts voted against recommending Abiomed be given permission to sell the device in limited numbers. At the time, the experts expressed concern that many AbioCor recipients suffered severe strokes, some fatal, that compromised their final weeks.

The FDA then worked with the company to refine the niche device.

“At the end of the day, the FDA was convinced the sponsor had met the bar,” said Dr. Bram Zuckerman, director of the FDA’s Division of Cardiovascular Devices.

The company now believes a redesigned cuff on the devices will prevent two bars from coming into contact with human tissue. That contact was believed to be the cause of the strokes in some of the first test patients, said Michael R. Minogue, the company’s president and chief executive officer.

The Danvers, Mass., company also hopes to implant the hearts in patients who can be treated with blood-thinning drugs, further reducing the risk of stroke, Minogue said in a recent interview. Two patients who received hearts with the redesigned cuff and anti-clotting drugs did not suffer strokes, he said.

“We want to focus on getting the right patients and getting them home, so whatever that number is, that is what it will be,” Minogue said.

Insurance question
The mechanical pump is expected to cost about $250,000. It is unclear whether insurance would cover it.

Abiomed eventually hopes 10 medical centers would be equipped to implant the hearts. The company agreed to conduct further studies of the devices, both in the lab and in 25 patients, the FDA said.

The devices themselves now last about 18 months, or longer than most patients receiving them can be expected to live.

On Tuesday, Minogue said the first surgeries to implant the artificial hearts would take place in six to eight months.

“It’s allowed us to move forward, to make science fiction 'science fact,”’ Minogue said of the FDA action. “We have a product called AbioCor that allows us to remove a person’s heart and keep them alive.”

The electrical current to power the device passes through the skin, without the need for wires, from a battery belt worn by the patient. The belt also can be plugged in. The device’s internal batteries, implanted along with a computer controller in the patient’s abdomen, can go more than an hour without recharging, allowing patients to shower.

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