The Food and Drug Administration gave preliminary approval today to Abiomed Inc. to sell its AbioCor device, the first fully implantable mechanical heart, just over a year after an FDA panel of outside experts voted against giving the Massachusetts company permission to sell the device.
The company received "humanitarian exemption" for the device, meaning it is approved for terminally ill heart failure patients who are believed to be in the last month of life and thus not eligible for a normal heart transplant.
The target patient population is small. An FDA spokesman expects that the company will sell between 25 and 50 devices a year, although the FDA has given it approval to sell as many as 4,000.
"This represents a culmination of 30 years of transplant research," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
The AbioCor is a 2-pound device implanted in the chest to replace the heart. It is powered by an internal battery that is recharged by an external power pack that transmits an unnoticeable current through the skin.
Once in place, this "robo-heart" runs on its own battery for up to an hour. The external battery pack will last for two hours, or the patient can strap on a power pack that plugs right into the wall and again transmits a tiny electrical current through the skin to the implanted heart.
The initial approval was granted after studying 14 human patients who'd received the mechanical heart. The patients lived for an average of five months after receiving the implant, which costs about $250,000.
Two patients died during the surgery. One patient lived 17 months after receiving the implant and leaving the hospital.
Some Excitement, a Lot of Caution
The approval "allows us to make science fiction science fact," said Michael R. Minogue, the company's president and chief executive officer.
The device might be exciting, but most heart surgeons remain skeptical about the FDA's approval.
"The results of AbioCor have not been good. ... I am surprised that the FDA gave their approval," said Dr. Frank Sellke, chief of cardiothoracic surgical research at Beth Israel Deaconess Hospital in Boston.
Sellke was involved in one of the original trials of the AbioCor, but his team never actually implanted the device into a patient because "it was a hard moral decision to make. We didn't know it it worked."
Creators of the artificial heart do agree that much research and development is still required . Follow-up studies to look at the device are planned in up to 10 facilities.
Some surgeons do not like the idea of an artificial heart. Sticking an artificial heart into a terminally ill patient is "like swatting a mosquito with a bazooka," said Dr. John Byrne, chairman of the department of cardiac surgery at Vanderbilt University Medical Center.
Byrne said there are many other things a heart surgeon can do for a patient besides implant an artificial heart.
"If a little train needs a push to get up the hill, you don't replace the whole train," he said.