- The Washington Times - Tuesday, September 5, 2006

ASSOCIATED PRESS

A Massachusetts company received federal approval yesterday to sell the world’s first fully implantable artificial heart.

The 2-pound mechanical 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 AbioCor artificial hearts, agency spokeswoman Susan Bro said. Surgeons likely will implant between 25 and 50 of the devices a year, though the company has approval to sell up to 4,000 annually, Miss 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 a third never regained consciousness. The rest survived an average of five months, though notably one patient lived 10 months after 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, Ky., which is expected to be among the five hospitals offering the mechanical hearts to patients.

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 specialists voted against recommending the Danvers, Mass., company be given permission to sell the device in limited numbers. At the time, the specialists 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 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 thinks a redesigned cuff on the devices will prevent two bars from coming into contact with human tissue. That contact was thought 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 mechanical pump is expected to cost about $250,000. It is not clear whether insurance would cover it.

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

Mr. Minogue said yesterday the first surgeries to implant the artificial hearts would take place in six to eight months.

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 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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