September 5, 2006

FDA OKs artificial heart implants for seriously ill

By Lisa Richwine

WASHINGTON (Reuters) - Seriously ill heart failure patients
expected to live only a month and ineligible for transplant can
get an implant of a permanent artificial heart, U.S. health
officials ruled on Tuesday.

The grapefruit-sized, titanium-and-plastic device --
Abiomed Inc.'s AbioCor artificial heart -- may give patients
only a few extra months and costs about $250,000.

The 14 men who received the two-pound artificial heart in a
study lived less than five months on average after surgery.
Only one was discharged from a hospital to live at home. One
patient survived 17 months and another 10 months.

U.S. Food and Drug Administration officials said approving
the AbioCor for limited use was a significant step forward in a
40-year quest to bring an fully implanted artificial heart to
market. But they said they hoped technology would improve to
extend survival.

"We see this as an important milestone .... Hopefully down
the road it will be better technology and more affordable
technology," said Dr. Daniel Schultz, director of the FDA's
Center for Device Evaluation and Research.

Schultz said officials decided a narrow group of dying
patients should have the option to try the artificial heart and
decide for themselves if was worth the risks and the cost.

"For many patients faced with death, the chance to have
additional time with family and friends, however limited, is a
chance they are willing to take," he said.

An advisory panel that reviewed the device in 2005 narrowly
urged the FDA to reject approval, even for patients with only
weeks to live. Many panel members said they were not sure
patients would live long enough with a good quality of life to
justify the risk of complications.

Half the patients in the study died from strokes, and 50
cases of severe bleeding were reported. Two patients did not
survive the surgery to implant the heart, and two others died
within 60 days.

Only about 25 to 50 heart failure patients per year are
expected to meet the AbioCor eligibility requirements, FDA
officials said. They must be ineligible for a heart transplant,
expected to live less than one month and have no other options

Many women may not qualify because a patient must have a
relatively large chest cavity. The men in the study had an
average height of 6 feet and a weight of 170 to 180 pounds.

Abiomed Chairman and Chief Executive Michael Minogue said
the company was working on a next-generation artificial heart
that it hopes to have ready by 2008. The newer device is 30
percent smaller than the current AbioCor and officials hope it
will extend the life of patients by 5 years.

"This is not the beginning and it is not the end. This
milestone is to move us forward into the next phase," Minogue
told Reuters.

The company is working to convince the Medicare federal
health program for the elderly and disabled to pay for implants
of the AbioCor, he said.

FDA officials approved the device implants under
"humanitarian" exemptions that allow a product to be used when
it is safe and has a "probable" benefit for a condition
affecting fewer than 4,000 patients per year. Humanitarian
approvals do not require the full-scale safety and
effectiveness testing of a standard device approval.

(Additional reporting by Susan Kelly in Chicago)