Hi,
     There are also others with this belief. Some would be the
families of people with less than one month to live due to impending
heart failure. The Abiocore heart has been shown to extend their life
expectancey by about four months. Cancer drugs have been approved with
efficacy in this range, yet the artificial heart is apparently not
going to be. Why not??

Thomas

WASHINGTON (AP) -- 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 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.