Federal regulators approved yesterday the first fully implantable artificial heart, which is to be used by dying heart failure patients who are not eligible for transplants.
The device, called AbioCor, was tested in 14 patients who lived an average of five months after receiving the mechanical heart.
The Food and Drug Administration said it approved the artificial heart for humanitarian use, which means the device was not tested in large clinical trials but might benefit 4,000 or fewer people a year.
The company that manufactures the device, Abiomed Inc. of Danvers, Mass., said up to 10 hospitals would begin offering the device within six to eight months.
Twenty-five to 50 of the devices are likely to be implanted each year, an FDA spokeswoman said.
An FDA advisory panel voted 7-6 last year that the risks outweighed the probable benefits to patients. One difficulty with the device is that it frequently causes blood clots, which can lead to strokes.
Nineteen strokes and 50 cases of serious bleeding were reported in the study.
One recipient survived for 10 months and another for 17 months. Both recovered sufficiently after heart implants to be discharged from the hospital.
Dr. Daniel Schultz, the FDA's top device regulator, said the device poses risks but that the agency thinks "there is a better chance than not that this device will help these patients."
"The choice is immediate death or a new and innovative technology," he said during a conference call.
Dr. Robert Higgins, head of the heart transplant program at Rush University Medical Center in Chicago, said, "The challenge, of course, is to select the patients who would benefit most from the artificial heart and who have the best chance to survive."
Heart failure is a condition in which the heart muscle cannot adequately pump blood through the body. Researchers have long struggled to develop a mechanical device to replace the heart, but progress has been slow.
AbioCor is for patients who have advanced heart failure - meaning they have months to live - and have complications such as diabetes or kidney failure that make them ineligible for a heart transplant.
The 2-pound artificial heart is about the size of a grapefruit and is powered by a rechargeable battery implanted in the patient's abdomen. An external unit recharges the battery through the skin, reducing the chance of infection from protruding wires.
The battery charge lasts for an hour, long enough for a patient to bathe or shower.
Because of its size, men are the most likely recipients. All of the patients in the study were men, averaging 6 feet tall and 160 to 170 pounds.
Abiomed Chief Executive Officer Michael Minogue said the company would recommend the device for patients who can tolerate anti-clotting drugs to reduce the risk of stroke. In the study, only the two patients who lived the longest received medicine to prevent blood clots.
Minogue said the cost of the device, including the surgery to implant it, could be as much as $550,000.
He said insurers will eventually cover AbioCor, although Medicare has a 20-year-old rule against reimbursement for artificial hearts.
Denise Gellene writes for the Los Angeles Times.