| Minimally
Invasive Device Increases Coronary Blood Flow and Provides Circulation
During High-Risk Cath Lab Procedures
Danvers, Mass., October 24, 2005—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, announced data presented at the Cardiovascular
Research Foundation’s (CRF) 17th annual TCT scientific symposium
in Washington, D.C., on its Impella Recover® LP 2.5, a minimally
invasive percutaneous ventricular unloading catheter. The single
center experience at the Academic Medical Center in Amsterdam of
21 patients has found that using the Impella as a left ventricular
assist device during high- risk angioplasty/stenting procedures
is both safe and feasible, providing hemodynamic support and improving
coronary circulation, without compromising coronary blood flow.
The results were described in two presentations.
The first presentation entitled, “Novel Hemodynamic Support
During High-Risk Coronary Intervention,” described the safety
and feasibility of using the Impella Recover LP 2.5 as a left ventricular
support in patients undergoing high risk angioplasty/stenting procedures.
The second presentation entitled, “LV (Left Ventricular)
Support Device Impella Increases Coronary Blood Flow in Patients
with Compromised LV Undergoing Angioplasty,” also by Dr. J.P.S.
Henriques, Cardiologist at the Academic Medical Center in Amsterdam,
additionally studied coronary blood flow in a total of 11 patients
undergoing high–risk angioplasties. This study showed that
the CE Marked Impella Recover LP 2.5 not only unloads the heart
but that can also increase coronary perfusion needed to provide
oxygen to the heart itself.
“In our experience using the Impella Recover LP 2.5, we found
the device to be easy-to-use in the cath lab setting and capable
of providing hemodynamic support and improved and sustained coronary
circulation,” said Dr. Henriques. “The Impella 2.5 enables
us to perform increasingly more difficult procedures like stent
placement and angioplasty in compromised patients with preserved
and even improved coronary circulation. We were pleased with our
findings and look forward to continuing to use and study this important
new technology.”
The Impella Recover LP (Left Percutaneous) 2.5 can deliver up to
2.5 liters of blood per minute and actively unloads the ventricle,
increasing the cardiac output and both coronary and end-organ perfusion.
It is minimally invasive and can be inserted into the left ventricle
in a catheterization lab via a standard guidewire. The Impella Recover
technology has been used in European centers to support more than
400 patients during high-risk percutaneous coronary intervention
(PCI), post PCI, Acute Myocardial Infarction (AMI or heart attack)
and patients with compromised hemodynamics. This device provides
cardiologists with the first technology designed to support patients
in the cath lab, during minimally invasive yet high-risk procedures,
such as high-risk stent placement.
“Dr. Henriques’ studies support the Impella Recover
technology as an early, minimally invasive Ventricular Assist Device
that can help protect and recover the patient’s natural heart,”
said Michael R. Minogue, Chairman, CEO and President of ABIOMED.
“ABIOMED will work towards approval of The Impella Recover
LP 2.5 to allow interventional cardiologists to provide their patients
with immediate support in the cath lab, without needing to send
the patient to the surgery suite, and without requiring that they
endure a sternotomy.”
IMPELLA DEVICES
Impella products are investigational devices limited by Federal
Law solely to investigational use in the United States and are not
yet available for sale in the United States.
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.
Contacts:
Liza Heapes
ABIOMED, INC
Media Relations
(978) 646-1668
mediarelations@abiomed.com
Investor Relations Contact:
Melody Carey
Rx Communications Group, LLC
(917) 322-2571
mcarey@rxir.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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