|FOR IMMEDIATE RELEASE
September 27, 2004
FOR MORE INFORMATION:
Investor Relations Contact:
Edward E. Berger,
Vice President for Policy, Reimbursement and External Relations
Thirteenth AbioCor® Patient
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 causes related to device operation.
The patient, 73-year-old Don Graham of New Albany,
Indiana, received the AbioCor on May 3, 2004 and was supported
for 147 days. The 6th patient to receive an 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 Don and his 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, 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