| Danvers,
Mass., September 27, 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 thirteenth AbioCor patient died on September
26 of device related causes.
The patient, 73-year-old Don Graham from New Albany, Indiana, received
the AbioCor on May 3, 2004 and was supported for 147 days. The 6th
patient to be implanted with the AbioCor at Jewish Hospital, he
is survived by his wife Bonnie and other family members.
No further information is available at this time. ABIOMED and Jewish
Hospital are investigating the situation and will report when an
analysis has been completed.
"Our thoughts and prayers are with Mr. Graham's family,"
said Michael R. Minogue, President and CEO of ABIOMED. 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.
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 currently manufactures
and sells the AB5000™ Circulatory Support System and the BVS®
5000 Biventricular Support System for the temporary support of all
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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