FDA panel rejects artificial heart
WASHINGTON – The first fully implantable artificial heart failed Thursday to win a critical endorsement from a government advisory panel.
The Food and Drug Administration committee reached its decision after a daylong hearing. The vote: six for, seven against, one abstention. The FDA usually follows advisers’ guidance.
“Clearly, we were disappointed,” says Michael Minogue, CEO of Abiomed of Danvers, Mass.
Abiomed acknowledges that the titanium and plastic AbioCor is no match for a natural heart. All 14 of the patients who tried the heart have died. Two died immediately after surgery. Only Tom Christerson, 71, who lived 17 months on the heart, was able to go home from the hospital.
The FDA’s chief reviewer, Julie Swain, asked whether the AbioCor was really “prolonging life, not prolonging death,” according to the Associated Press.
The heart’s advocates called the AbioCor a major advance in the quest for a replacement human heart. The device successfully sustained 12 of the patients for two to 17 months.
The grapefruit-sized AbioCor consists of a titanium and plastic pump, an internal microprocessor to monitor and control blood flow and an implanted, rechargeable battery. An external power unit transmits electricity through the skin to reduce the risk of infection from protruding wires.