FDA panel deals blow to AbioCor heart device

GAITHERSBURG, Md. -- Because so many of the 14 gravely ill patients with permanently implanted AbioCor artificial hearts suffered in their final days, federal advisers yesterday decided the device is not ready for wider use.

AbioCor's maker, Danvers-based Abiomed Inc., sought a humanitarian exemption, which meant it only needed to prove the probable benefits to patients outweighed the risks. The company did not have to show the artificial heart was effective.

During a hearing, a Food and Drug Administration panel struggled with whether to recommend the agency approve or deny the application. Abiomed wanted permission to use the device in about 4,000 patients annually. The FDA usually heeds the advice of its panels.

Before the vote, one adviser, Dr. Mitchell Krucoff, asked whether the panel should just recommend ''continuing research" on the device.

Cardiologists, statisticians, and others who gathered for the hearing found AbioCor statistics sobering: At least six of the 14 patients, perhaps seven, suffered life-ending strokes. Others had strokes that resulted in irreversible neurological problems. One man was comatose for 53 days after surgery.

Many questioned Abiomed's confidence that corrections it made to the device and revised protocols for administering blood-thinners would prevent stroke-inducing blood clots.

Another panel member, Dr. Eugene Blackstone, criticized Abiomed for presenting ''bogus statistics." Blackstone, a Cleveland Clinic cardiac surgeon, said, ''I find it difficult to interpret the data when they're presented in ways that are unhelpful and, I think, incorrect."

Even testimony on behalf of Tom Christerson, a patient who survived for 17 months and returned home to a somewhat normal life, ended up supporting skeptics on the panel.

Krucoff asked why the patient, whom he referred to by number, decided not to be implanted with a new AbioCor after a crucial part wore out on the first one.

''He said he had that faith in it once, and he just didn't want to mess up a good thing," said Patti Pryor, Christerson's daughter.

According to the FDA, the implants clearly did not benefit four patients, including two who died in the operating room and one who was left comatose. Christerson's experience counted as a probable improvement in quality of life.

''There's a real question" about the remaining nine, said Dr. Julie Swain, a cardiovascular surgeon who serves as an FDA consultant.

But one panel member, Dr. Thomas Ferguson, a Washington University professor emeritus, praised AbioCor as a ''much, much better device" than earlier models and reminded the group that the men in the trial were ''salvage patients" who were likely to die within 30 days.

JoAnn Lindenfeld, a University of Colorado heart transplant expert, pointed to AbioCor recipients with serious neurological problems who lived for weeks after suffering serious strokes. Quality of life, ''not just how long" they lived, is important, she said.

Trading of Abiomed stock was halted during the meeting.

Diedtra Henderson can be reached at dhenderson@globe.com.