FDA Approves New Type of Artificial Heart
Federal regulators on Tuesday approved the first fully implantable artificial heart for use by dying heart failure patients who are not eligible for a transplant.
The device, called AbioCor, was tested in 14 male patients. The 12 who survived the surgery 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 -- a designation that meant 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 the next six to eight months.
The actual number of devices implanted each year should range from 25 to 50, an FDA spokeswoman said.
The approval came 15 months after an FDA advisory panel voted 7-6 that the risks outweighed the probable benefits to patients. A difficulty of the device is that it frequently causes blood clots, which can lead to strokes.
Nineteen strokes and 50 instances of serious bleeding were reported in the study.
Two patients survived for 10 months and 17 months, respectively, and recovered to the point where they could leave the hospital, the company said.
Dr. Daniel Schultz, the FDA’s top device regulator, acknowledged the device carried risks but the agency believed that “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.”
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 only months left to live -- and have complications such as diabetes or kidney failure that make them ineligible for a heart transplant.
Weighing 2 pounds, the device is 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.
Most of the time the patients get power from a wall source, but there is a portable power source good for two hours. For about an hour patients can move about without being attached to any power source.
Because of its size, the device is most likely to be used in men. All patients in the study were men, averaging 6 feet tall and 160 to 170 pounds.
Abiomed Chief Executive 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 two patients -- those who lived the longest -- received medicine to prevent blood clots.
Minogue said the cost of the device, including surgery to implant it, could run as high as $550,000.
He said he believed insurers would eventually cover AbioCor, although Medicare has a 20-year-old rule against reimbursement for artificial hearts, he said.
Alan Sager of the Boston University School of Public Health said FDA approval was the first step toward Medicare coverage and that the federal agency would probably cover the device after a review.
“If it works clinically and seems safe and effective, they are obliged to cover it without considering the cost,” he said.
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