| Exclusive
FDA Labeling on Medical Devices for All Indications of Cardiac Recovery
Danvers, MA and Chicago, January 23, 2006—ABIOMED,
Inc. (NASDAQ: ABMD), a leading developer, manufacturer and marketer
of medical products designed to assist or replace the pumping function
of the failing heart, today announced the showcase of its FDA approved
AB5000™ Circulatory System at the 42nd Society of Thoracic
Surgeons (STS) Conference being held at McCormick Place in Chicago,
from January 30-February 1, 2006. ABIOMED will occupy booth #106
at the STS Conference.
The AB5000 provides temporary support for one or both sides of
the natural heart in circumstances where the heart has failed, giving
the patient's heart the opportunity to rest and potentially
recover - and giving surgeons the therapeutic flexibility necessary
to determine the best endpoint for treatment. The AB5000 and ABIOMED's
BVS® 5000 are the only devices approved by the FDA for the recovery
of the natural heart. ABIOMED's AbioCor® Implantable Replacement
heart, which is not yet FDA-approved and not for use in the U.S.,
will also be on display at the STS Conference.
At this internationally attended meeting, ABIOMED will also display
its Impella Recover® LP 2.5 and 5.0 which are available in Europe
under the CE Mark and are investigational in the United States.
The Impella Recover 2.5 and 5.0 are the world's smallest,
minimally invasive, high performance micro-blood pumps. They utilize
integrated motors and sensors for use in interventional cardiology
and cardiovascular surgery. An incision in the leg allows these
devices to be inserted percutaneously into patients, similar to
a standard angioplasty procedure, in order to help restore blood
flow.
"ABIOMED continues to broaden and enhance its suite of advanced
medical devices designed to provide circulatory care options for
our customers," said Christopher Macdonald, Senior Vice President
of Global Sales for ABIOMED. "We have made significant progress
in expanding our global sales and clinical teams, and are excited
to bring the CE-Marked Impella devices to our European-based interventional
cardiologists and cardiac surgeons."
ABIOMED senior management, key scientists and engineers will host
dinner meetings on January 29th through February 1st with leading
physicians and customers to discuss the Company's advanced
technologies and market driven solutions. STS attendees interested
in participating in these dinner roundtable discussions should contact
Elena Kfoury at 978-646-1520 or ekfoury@abiomed.com.
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 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.
Media Contact:
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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