News Releases
FOR IMMEDIATE RELEASE
July 08, 2004 |
FOR MORE INFORMATION:
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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13th ABIOCOR® REPLACEMENT
HEART PATIENT
REACHES 60 DAY MILESTONE
Danvers, Mass., July 8, 2004 -- ABIOMED, Inc. (NASDAQ:
ABMD) today announced that the 13th patient to receive the AbioCor® Implantable
Replacement Heart in a procedure performed May 3rd by a Jewish
Hospital/University of Louisville medical team has surpassed the
milestone of 60 days on support.
The patient is in stable condition, has been weaned
from ventilator support, has been transferred from intensive care
to a transitional
care unit and has begun physical therapy, according to Drs. Laman
Gray and Robert Dowling, lead investigators for the AbioCor trial
at Jewish Hospital.
ABIOMED will continue its policy of making more
specific patient information available only at the discretion of
the patient and
patient’s family.
Candidates for the clinical trial must suffer
from biventricular heart failure, be ineligible for heart transplantation
at the time
of screening 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, 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
trial.
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