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FDA approves artificial heart
A Massachusetts company received federal approval to sell the world's first fully implantable artificial heart. The 2-pound mechanical hearts would be used only in patients who are close to death and have no other treatment options.
The Food and Drug Administration granted Abiomed Inc. a humanitarian exemption allowing it to sell the AbioCor artificial hearts, agency spokeswoman Susan Bro said. Surgeons likely will implant between 25 and 50 of the devices a year, though the company has approval to sell up to 4,000 annually, Bro said.
So far, the artificial heart has been tested in only 14 men. Two died from the operation, and another never regained consciousness. The rest survived only an average of five months, though notably one patient lived 10 months following surgery, and another 17 months. The latter patient, Tom Christerson, died in February 2003 after moving home.
The company said earlier that it would begin implanting the artificial hearts at five hospitals around the country once doctor training is complete. Unlike other permanent artificial hearts, including the Jarvik-7 implanted in Barney Clark in 1982, the AbioCor is fully contained within the chest, with no outside wires.
Abiomed is targeting men - but not excluding women - with heart failure who are too sick for a heart transplant, have exhausted other options and are likely to die within a month. The current device is too large for about 90 percent of U.S. women and many men. The company is developing a smaller and longer-lasting version.
The mechanical pump is expected to cost about $250,000. It is unclear whether insurance would cover it. Abiomed eventually hopes 10 medical centers would be equipped to implant the hearts. The company agreed to conduct further studies of the devices, the FDA said. The devices themselves now last about 18 months, or longer than most patients receiving them would have been expected to live.
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