| -Indication
for Use is Support During High-Risk Angioplasty
Danvers, Mass., May 25, 2006—ABIOMED, Inc.
(NASDAQ: ABMD) today announced that the U.S. Food and Drug Administration
(FDA) granted approval for the Company to commence its pilot clinical
trial immediately in the United States for the IMPELLA® 2.5
minimally invasive ventricular assist device (VAD). The approval
is conditioned upon the Company’s submission of additional
information to the FDA over the next 45 days. The indication for
use is support during “high-risk” angioplasty for up
to five days as a left ventricular assist device. Angioplasty, performed
in the catheterization lab, is the insertion of a catheter-guided
balloon and is used to open a narrowed coronary artery. A stent
(a wire-mesh tube that expands to hold the artery open) is usually
placed at the narrowed section. High-risk angioplasty is defined
as patients undergoing angioplasty on an unprotected left main coronary
artery lesion, or the last patent coronary conduit, and poor cardiac
function.
“We are very excited to receive this approval to begin the
trial for our breakthrough IMPELLA 2.5 product. We believe IMPELLA
will change the standard of care in the cath lab,” stated
Michael R. Minogue, Chairman, President and CEO of ABIOMED. “Our
results in Europe for high-risk patients have been outstanding.
We estimate that approximately 5%-10% of the one million U.S. angioplasty
patients could benefit in the future from IMPELLA technologies.”
“The IMPELLA 2.5 is a highly advanced, minimally invasive
VAD that can be utilized in the cath lab to provide patients support
during a procedure,” stated William O’Neill, Corporate
Director of Cardiology, William Beaumont Hospital System. “We
hope to demonstrate that the IMPELLA system, with its unique capability
to unload the left ventricle and enhance flow to the body, will
improve the safety of complex, high-risk angioplasty procedures.”
The Company intends to conduct the pilot investigation on the IMPELLA
2.5 with no more than seven hospitals and 20 patients. Based on
the Centers for Medicare and Medicaid (CMS) category B2 status,
the hospitals could be eligible for full reimbursement during the
trial. ABIOMED will conduct a conference call in the future to outline
the details of the trial.
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 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. In Europe, ABIOMED offers the IMPELLA®
RECOVER® minimally invasive cardiovascular support systems under
CE Mark approval. The IMPELLA products are not yet available for
sale in the United States. The Company’s AbioCor® Implantable
Replacement Heart was the subject of an initial clinical trial 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. For additional information please visit:
www.abiomed.com.
Contacts:
Liza Heapes
ABIOMED, INC.
Media Relations
(978) 646-1668
mediarelations@abiomed.com
Daniel Sutherby
ABIOMED, INC.
Chief Financial Officer
(978) 646-1812
ir@abiomed.com
FORWARD-LOOKING STATEMENTS
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.
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