| 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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