| Danvers,
Mass., April 22, 2004 -- ABIOMED, Inc. (NASDAQ: ABMD) today
announced that the 12th patient to receive the AbioCor® Implantable
Replacement Heart in a procedure performed February 20th by physicians
at the Texas Heart Institute and St. Luke's Episcopal Hospital has
surpassed the milestone of 60 days on support.
The patient is in stable condition and has been weaned from ventilator
support, but is still recovering due to other medical conditions,
according to Dr. Bud Frazier, Chief of Cardiopulmonary Transplantation
and Director of Surgical Research at the Texas Heart Institute,
and Chief of Transplant Services at St. Luke's Episcopal Hospital.
Dr. Frazier also commented that the device continues to function
well.
ABIOMED will continue its policy of making more specific patient
information available only at the discretion of the patient and
patient's family.
"While I understand the tremendous interest this trial has generated,
our first commitment is to the patient and respecting his privacy,"
commented Michael R. Minogue, President and CEO of ABIOMED. "Our
thoughts and prayers are with the patient and his family."
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
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