| Advanced
Medical Technology Indicated for Use with Low Cardiac
Output after Cardiac Surgery
DANVERS, Mass. (June 27, 2006)—Abiomed,
Inc. (NASDAQ: ABMD) today announced conditional approval
by the U.S. Food and Drug Administration (FDA) of
its Investigational Device Exemption (IDE) for the
IMPELLA 5.0 unique, catheter-based Circulatory Support
Systems. Clinical trials in the U.S. are to begin
immediately. The IMPELLA® RECOVER 5.0 devices
are already available in Europe under CE Mark approval
and have been used to treat more than 250 patients
in Europe in need of cardiac support resulting from
postcardiotomy cardiogenic shock, myocarditis, low
cardiac output post-acute myocardial infarction, or
post-coronary intervention procedures, or as a bridge
to other circulatory support devices, including Abiomed's
AB5000™ and BVS® 5000 Circulatory Support
Systems.
The pilot study in the United States for the IMPELLA
5.0 will enroll up to 20 patients at seven U.S. sites
including: the University of Maryland, Massachusetts
General Hospital, Lankenau Hospital in Philadelphia,
Robert Wood Johnson Hospital in New Jersey, New York
Presbyterian Hospital, Texas Heart Institute and Penn
State Milton S. Hershey Medical Center in Pennsylvania.
The study will include postcardiotomy patients who
have been weaned from heart-lung machines and whose
hearts require added support to maintain good blood
flow. The study will enroll those patients that would
typically need more flow and hemodynamic support than
provided by an Intra-Aortic Balloon Pump (IABP).
"The IMPELLA micro-VAD technology is likely a
window into the future where heart assist is headed.
We look forward to evaluating the safety of this device
in patients whose hearts are weakened after heart
surgery. Because of the small size, they are assembled
on a catheter that can be placed through an artery
and into the heart," said Bartley Griffith,
M.D., Chief of Cardiac Surgery and Heart & Lung
Transplantation at the University of Maryland School
of Medicine and Principal Investigator of the study.
"We are excited to receive this approval for
the IMPELLA 5.0 as we believe this technology will
provide surgeons with a potent, minimally invasive,
circulatory support system. Abiomed's results
with the IMPELLA 5.0 in Europe have been excellent
and we look forward to ultimately bringing this technology
to the United States through this study," said
Michael R. Minogue, Chairman, CEO and President of
Abiomed.
ABOUT THE IMPELLA 5.0
The IMPELLA 5.0 technology consists of catheters that
can be introduced percutaneously through a cut-down
and surgically. Other IMPELLA devices currently available
in Europe under CE Mark approval include the IMPELLA®
2.5, and the IMPELLA® RD.
The IMPELLA 5.0 Pumps can achieve flows of up to 5.0
liters per minute, and actively unload the ventricle,
reducing myocardial workload and oxygen consumption
while increasing cardiac output and coronary and end-organ
perfusion.
IMPELLA 5.0 devices have been the subject of more than
10 clinical papers reporting European experiences.
Recent studies have shown that the IMPELLA 5.0 can
provide effective and adequate support for high-risk
surgery patients, as well as patients presenting with
marginal cardiac output as well as severe cardiogenic
shock.
The IMPELLA 5.0 Support Systems are intended to be used for up
to seven days as left ventricular cardiac assist devices. The systems
are comprised of the IMPELLA mobile console, the IMPELLA bearing
purger and the IMPELLA 5.0 catheter based rotary blood pumps.
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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