The following news item answers one of the questions I had yesterday: Where will the trials take place? The rest of the article basically repeats information in other news releases:
Wednesday January 31 6:11 AM ET
Feds OK Tests of Artificial Heart
BOSTON (AP) - The Food and Drug Administration
(news - web sites) has approved experimental use in
humans of a fully implantable, battery-powered artificial
heart.
Abiomed Inc., the Danvers-based company that makes the
2-pound, fist-sized pump, said Tuesday the FDA approved
use of the device in five patients, all of them too sick for
heart transplants.
The grapefruit-sized artificial heart is inserted in the body
along with a rechargeable battery that can work on its own
for about 30 minutes. The battery can be recharged through the skin.
The patient can also wear an external battery pack that can last for several hours.
The mechanical heart, called the AbioCor, is expected to enable patients to
participate in normal activities, including light sports.
Earlier versions of an artificial heart, including the Jarvik-7, were powered outside
the body. The latest device, which has been tested on calves, is designed as a
permanent replacement to a heart transplant.
The AbioCor will sell initially for $75,000 to $100,000, analysts projected, making
it comparable to the cost of open heart surgery, but less than the cost of heart
transplant surgery.
An estimated 100,000 Americans suffer from end-stage heart failure each year, but
only about 2,000 human hearts are available for transplants.
``The medical system desperately needs something to fill in that very big gap,'' said
Phillip E. Nalbone, an industry analyst with Salomon Smith Barney in San Diego.
Tests on the device were to be conducted on patients at Hahnemann University
Hospital in Philadelphia; Jewish Heart Lung Hospital in Louisville, Ky.; the Texas
Heart Institute in Houston; and Massachusetts General Hospital and Brigham and
Women's Hospital in Boston.
The implantation procedure would have to be reviewed and approved by the
hospital's institutional review board, which goes over experimental procedures to
make sure they're safe.
The AbioCor is expected to be much more advanced than the Jarvik-7, which kept
several people, including retired Seattle dentist Barney Clark, alive for several days
in the early 1980s.
The Jarvik-7 was considered a failure because Clark suffered strokes and severe
depression while he was tethered to a power source the size of a washing machine.
That device was eventually recalled.
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On the Net:
Abiomed: abiomed.com
FDA: fda.gov
dailynews.yahoo.com
Lynn |
