| Cause
of Death is Pre-existing Multi-Organ Failure
Danvers, Mass., May 17, 2004 -- ABIOMED, Inc.
(NASDAQ: ABMD) announced today that Dr. Bud Frazier, investigator
for the AbioCor® clinical trial at the Texas Heart Institute,
has reported that the family of the twelfth AbioCor patient opted
to take him off support on Sunday, May 16th. This decision was made
in consultation with the medical team as a result of unrecoverable
liver and kidney failure, conditions that pre-dated the AbioCor
implant. During his 85 days on support, no thrombo-embolic strokes,
device malfunctions or other significant adverse events related
to the AbioCor were observed.
The patient, 63 year-old Jay Croft, received the AbioCor on February
20, 2004.
"On behalf of the entire ABIOMED team, I wish to offer condolences
to the family of this brave patient who chose to participate in
this experimental trial to extend his life and help ensure extended
life for future heart failure patients," said Michael R. Minogue,
President and CEO of ABIOMED. "We are grateful for the contribution
he and his family chose to make. Our thoughts and prayers are with
them during this time. "
Candidates for the 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. ABIOMED has announced its intention
to seek 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 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.
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Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
Investor Relations Contact:
Edward E. Berger, Ph.D.
Vice President for Policy, Reimbursement and External Relations
(978) 646-1411
ir@abiomed.com
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