ABIOCOR IMPLANTABLE REPLACEMENT
HEART PROCEDURE PERFORMED AT JEWISH HOSPITAL BY UNIVERSITY OF
LOUISVILLE SURGEONS
Louisville,
Kentucky - Jewish Hospital and the University
of Louisville announced today that the leaders of the Louisville-based
AbioCor (pronounced "AB'-EE-O-KOR") clinical and research
teams, Drs. Laman A. Gray, Jr. and Robert D. Dowling, performed
the world's first implantation of ABIOMED, INC's AbioCor Implantable
Replacement Heart on Monday, July 2 in a seven-hour procedure
at Jewish Hospital in Louisville, Kentucky. The patient is resting
comfortably.
Consistent with the previously announced
"quiet period" policy, additional information will be
available at a news briefing to be held on Wednesday,
July 4 at 10 a.m. (EDT), atop the Rudd Heart and Lung Center
on the Jewish Hospital campus, 201 Abraham Flexner Way. ADDITIONAL
INFORMATION WILL NOT BE RELEASED PRIOR TO THE NEWS BRIEFING.
The news conference will be up-linked
live via satellite coordinates Ku-Band SBS 6, Transponder 15,
Horizontal Frequency 12068 MHZ, 74 degrees West. The audio frequency
is 6.20/6.80. The signal will be available from 10-11 a.m. (EDT),
Wednesday, July 4.
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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. The Company's
first generation AbioCor Implantable Replacement Heart is ready
for implantation in selected patients as part of an initial clinical
trial conducted under an Investigational Device Exemption (IDE)
from the United States Food and Drug Administration (FDA).The
AbioCor has not been approved for commercial distribution, and
is not available for use or sale outside of the initial clinical
trial. ABIOMED currently manufactures and sells the BVS, a heart
assist advice for the temporary support of all patients with failing
but potentially recoverable hearts.
This Release contains forward-looking
statements, including statements regarding the anticipated timing
and results of clinical trials for the AbioCor. ABIOMED'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 detailed in the Company's filings with the Securities and
Exchange Commission. 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.
Jewish Hospital is among the
top ten cardiac centers in the United States and, along with the
University of Louisville, is dedicated to excellence in clinical
care, research and education. University of Louisville surgeons
at Jewish Hospital have performed many heart care "firsts,"
including Kentucky's first heart transplant, the world's first
heart transplant following the use of a Thoratec left ventricular
assist device, the world's first endoscopic saphenous vein harvest
and the first ventricular remodeling in the region.