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.
The AbioCor artificial
heart has been tested in only 14 men. Two died from the operation;
another never regained consciousness.
The rest survived only an average of five months, with one
exception: a man who lived 17 months, until the mechanical heart
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.
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.
wanted more information on how to decide which dying patients were
appropriate candidates, and how to lower their stroke
"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
"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
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