FDA Panel Refuses to OK Abiomed Artificial Heart

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. Many members of a Food and Drug Administration advisory panel said they were not yet convinced that the probable benefits would outweigh the chances of strokes or serious bleeding.

“There are very real risks to this device,” panel member Dr. Joanne Lindenfeld said.

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

Abiomed, based in Danvers, Mass., 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.

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. Two were discharged from the hospital before they died.

“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.

But two patients did not survive the operation, and two others died within 60 days. Seven patients died from strokes, and 50 cases of serious bleeding were reported, FDA reviewers said.

Abiomed has been working for 40 years to develop a fully implanted replacement heart.

Trading in Abiomed shares was halted on Nasdaq during the panel meeting.