| DANVERS,
Mass. (December 30, 2004) – ABIOMED, Inc. (NASDAQ:
ABMD) a manufacturer of products for circulatory care and support,
today announced that a patient has survived after being on AB5000
ventricle support for both sides of his heart for 37 days.
The patient, Cornelius King, a resident of Cicero, New York, was
implanted first with bi-ventricular BVS 5000 and then AB5000 support
following an acute myocardial infarction, also known as an AMI or
heart attack, with subsequent cardiogenic shock. Mr. King also suffered
acute kidney failure as a result of the heart attack and required
dialysis. While on bi-ventricular heart support with the AB5000,
his condition stabilized and his overall circulation improved to
the point where his kidneys regained function. After giving his
heart a full chance for recovery, Mr. King's doctors determined
that in his case cardiac recovery would not occur, and he received
a heart transplant.
According to the American Heart Association, more than 865,000
patients in the United States suffer from heart attacks each year.*
Cardiogenic shock complicates 7 to 10 percent of heart attack cases
and has been associated with a 70 to 80 percent mortality rate.**
However, new technologies such as early revascularization and ventricular
assist devices have been shown to dramatically improve survival.
ABIOMED's ventricular assist devices, the AB5000 and the BVS 5000,
are the only devices approved for Bridge-to-Recovery treatment following
AMI-cardiogenic shock.
"Cases like these are very encouraging, and demonstrate that
the AB5000 represents a tremendous opportunity to reduce mortality
for the tens of thousands of patients suffering from AMI-cardiogenic
shock. By implanting the AB5000 as early as possible, patients suffering
cardiogenic shock following a heart attack are afforded the best
chance for recovery. For many patients, recovery will mean returning
home with their natural heart. But even when it is determined that
heart recovery is not possible, patients who receive support on
the AB5000 are able to improve their condition and have all major
organs supported while the next step in treatment is evaluated,"
commented Dr. Todd Massey, Director of the Artificial Heart Program
and Surgical Director of the Cardiac Transplant Program at Strong
Memorial Hospital in Rochester, NY.
"Cases like these demonstrate that the AB5000 can provide
extended periods of support and provide major organs, including
the heart, kidneys, and liver, with a full opportunity for recovery,"
said Michael R. Minogue, CEO and President of ABIOMED. "For
those patients whose hearts cannot recover, time on the BVS and
AB5000 helps the patient stabilize and protects their organs. We
have had patients on AB5000 bi-ventricular support beyond 90 days."
About ABIOMED
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. In September 2004,
ABIOMED applied for initial FDA market approval for the AbioCor
Implantable Replacement Heart to treat a defined subset of irreversible
end-stage heart failure patients under a Humanitarian Device Exemption.
This Release contains forward-looking statements, including
statements regarding development of ABIOMED's existing and
new products, the Company's progress toward commercial growth,
and future opportunities. The Company's actual results may
differ materially from those anticipated in these forward-looking
statements based upon a number of factors, including uncertainties
associated with development, testing and related regulatory approvals,
anticipated future losses, complex manufacturing, high quality requirements,
dependence on limited sources of supply, competition, technological
change, government regulation, future capital needs and uncertainty
of additional financing and other risks and challenges detailed
in the Company's filings with the Securities and Exchange
Commission, including the Annual Report filed on Form 10-K. Readers
are cautioned not to place undue reliance on any forward-looking
statements, which speak only as of the date of this Release. The
Company undertakes no obligation to publicly release the results
of any revisions to these forward-looking statements that may be
made to reflect events or circumstances that occur after the date
of this Release or to reflect the occurrence of unanticipated events.
*Goldberg RJ, Gore JM, Alpert JS, et al. NEJM 1991; 325: 1117-22.
** Kiullip T III, Kimball JT. Am J Cardiol 1967; 20:457-64. Hochman
JS, et al. NEJM 1999 Aug; 341: 625-634.
Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
Investor Relations:
Jane Petrino Noonan/ Russo
(212) 845-4274
jane.petrino@eurorscg.com
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