FDA Gives Go-Ahead to Artifical Heart
Sept. 5, 2006 — -- 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.
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.
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