The rest survived only an average of five months, with one exception: a man who lived 17 months, until the mechanical heart wore out.
Still, maker Abiomed Inc. asked the Food and Drug Administration for permission to sell the device, under a special rule allowing sale of medical devices with less than the normally required proof of benefit if they're for small groups of people who have no treatment options.
Abiomed is targeting heart failure sufferers too sick for a heart transplant, who have exhausted other options and are likely to die within a month.
Thursday, advisers to the FDA were moved by two families of recipients who called the extra time priceless. But panelists were more worried that many AbioCor recipients suffered severe strokes, some fatal, that compromised their final weeks.
Ultimately, panelists wanted more information on how to decide which dying patients were appropriate candidates, and how to lower their stroke risk.
"I voted against (this) with some angst," said adviser Dr. Clyde Yancey of the University of Texas Southwestern Medical Center, after the panel voted 7-6 that the heart's probable benefit didn't outweigh the risks.
That is an "agonizingly thin" line, added Dr. John Somberg of Rush University.
The FDA is not bound by its advisers' recommendations but usually follows them.
"This one, I think, is a real dilemma," said the FDA's chief reviewer, Dr. Julie Swain. She asked whether, for most patients, the AbioCor was really "prolonging life, not prolonging death."
The AbioCor is the first attempt at a mechanical heart with no wire sticking through the skin. The battery that powers the softball-sized device is recharged by an electrical charge through the skin.
Abiomed's chief scientific officer, Robert Kung, pledged that if his company were authorized to sell the heart, the company would allow implants at only 10 hospitals where surgeons would get special training.
He said the company also would continue studying how the next 20 patients fare.
If approved, the implant is expected to cost about $250,000. It is unclear if insurance would cover it. It is too large for most women; the company is developing a smaller version.
The first fully implantable artificial heart hasn't yet proved its promise, say government advisers worried that most of the few recipients so far suffered serious side effects for little gain.
