US panel narrowly rejects Abiomed artificial heart

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Abiomed Inc.’s artificial heart is not ready for U.S. approval even for dying patients with less than a month to live, a U.S. advisory panel narrowly ruled on Thursday.

The 7-6 vote, with one abstention, was a setback for Abiomed’s four-decade quest to bring the first fully implanted replacement heart to the market.

Doctors have implanted the experimental AbioCor device in 14 patients, who lived less than five months on average after the surgery. One survived 17 months.

Many members of a Food and Drug Administration advisory panel said they were not sure patients would live long enough with a good quality of life to justify risks of complications. Half the patients died from Strokes, and 50 cases of severe bleeding were reported.

“At the present time, I don’t think it’s probable the next patient would have a benefit from this device. It’s more likely they would have a major safety issue,” panel member Dr. Joanne Lindenfeld said.

Two patients did not survive the surgery to implant the heart, and two others died within 60 days. Only two were able to live outside the hospital, critics noted.

The FDA will make the final decision on whether to approve AbioCor, but the agency usually follows recommendations from its panels of outside experts.

Some panel members said they would support AbioCor if researchers could figure out appropriate anti-clotting therapy to prevent strokes without causing excessive bleeding, and if future patients were closely tracked.

Abiomed wants to sell the grapefruit-sized device made of titanium and plastic for heart-failure patients who are too sick for transplants and expected to live only a month. The device’s expected price tag is $250,000.

All 14 patients who got the AbioCor have died. They survived 138 days on average with the implant, and one lasted 512 days before the device failed.

“We have the capability of returning dying patients to some level of normal living,” Robert Kung, Abiomed’s chief scientific officer, told the panel.

Some recipients were able to go to restaurants and sporting events, and one welcomed a great-grandchild, he said.

Supporters said patients near death deserved to try the artificial heart if they wanted.

“They have nothing to be offered to them at that point, at less than 30 days (to live). I think going forward they have at least some chance of getting better” with the AbioCor, panel member Dr. George Vetrovec said.

Robert Tools, the first AbioCor recipient, lived five months with the replacement heart. Prior to surgery he had been barely able to leave his chair as his natural heart deteriorated, his widow told the panel.

After the implant, “he looked better than he had in years. Every day he would improve a little bit. We got our quality of life back. We would go out to lunch, out to dinner,” Carol Tools said.

Abiomed has been working for 40 years to develop a fully implanted replacement heart. Past artificial hearts required patients to be connected to a large console, or have wires or tubes piercing the skin.

The FDA cleared an artificial heart made by Syncardia Systems Inc. last October for patients awaiting transplants. Those patients must stay in the hospital connected to a computer to regulate blood flow.

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