| DANVERS,
Mass. (May 26, 2004) -- ABIOMED, Inc., (NASDAQ:ABMD) today
announced the 14th implantation of the AbioCor® Implantable Replacement
Heart. The implant was performed on May 24 in Louisville, KY by a
Jewish Hospital/University of Louisville medical team led by surgeons
Laman Gray, M.D. and Rob Dowling, M.D. The procedure went well and
without complication. The patient is recovering, and is in critical
but stable condition.
Consistent with ABIOMED's established policy for the AbioCor clinical
trial, no further patient information will be released at this time.
Additional information will be available when the clinical team
and the patient's family deem it is appropriate.
A product of three decades of research, the AbioCor is the subject
of an initial clinical trial that began when the first patient was
successfully implanted in July 2001. 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.
###
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
|