| Danvers,
Mass., November 5, 2004 -- ABIOMED, Inc. (NASDAQ: ABMD) has
been informed by Drs. Laman Gray and Rob Dowling, investigators for
the AbioCor® clinical trial at Jewish Hospital/University of Louisville,
that the 14th AbioCor patient passed away on November 4, 2004 as a
result of unrecoverable multi-organ failure. The device worked well
during his 166 days on support, with no malfunctions occurring.
The patient, William Wiley, 73, received the AbioCor on May 24,
2004 and was resident of Glasgow, KY.
"We consider William to be a true hero who has made a significant
contribution to advancing the care of patients with heart failure,"
said Dr. Dowling.
"Our entire team is grateful to William and his family for
the contribution they have made for patients," added Michael
R. Minogue, President and CEO of ABIOMED. "We know this is
a difficult time for the family and our thoughts and prayers are
with them."
Candidates for the AbioCor clinical trial must suffer from biventricular
heart failure, be ineligible for heart transplantation and not able
to be helped by any other available therapy, and have a high probability
of dying in less than 30 days. In September, ABIOMED applied for
initial FDA market approval this year for the AbioCor to treat a
defined subset of irreversible end-stage heart failure patients
under a Humanitarian Device Exemption.
Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced
"AB'-EE-O-MED") is a leading developer, manufacturer
and marketer of medical products designed to assist or replace the
pumping function of the failing heart. ABIOMED, which currently
sells the BVS® 5000 Biventricular Support System and the AB5000™
Circulatory Support System, is the market leader in devices for
the temporary support of patients with failing but potentially recoverable
hearts. The company's AbioCor® Implantable Replacement
Heart is the subject of an initial clinical trial being conducted
under an Investigational Device Exemption from the United States
Food and Drug Administration. The AbioCor has not been approved
for commercial distribution, and is not available for use or sale
outside of the initial clinical trial.
###
Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
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