| Safety
and Feasability of World's Smallest Micro-Ventricular Assist Device
Shown in Cath-Lab Setting for High-Risk, Minimally Invasive Procedures
Danvers, Mass., April 18, 2006—ABIOMED,
Inc. (NASDAQ: ABMD), today announced peer-reviewed data on the IMPELLA®
RECOVER® LP 2.5 in the April issue of the American Journal of
Cardiology (Volume 97, Issue 7). The study by Dr. J.P.S. Henriques,
Cardiologist at the Academic Medical Center in Amsterdam, included
19 patients with high-risk Percutaneous Coronary Interventions (PCI)
and who were poor candidates for surgery.
This article entitled, “Safety and Feasibility of Elective
High-Percutaneous Coronary Intervention Procedures with Left Ventricular
Support of the IMPELLA RECOVER LP 2.5,” found:
- The device successfully supported 100% of patients undergoing
elective high- risk PCI procedures
- There were no significant device-related adverse events
- No aortic valve regurgitation during device operation
- There were no strokes
- There was no limb pain or ischemia
- No post procedure complications
“Our experience with the IMPELLA RECOVER LP 2.5 has been
quite positive. The device has proven to be safe and I am pleased
with its ease-of-use and ability to provide both hemodynamic support
and improved, sustained coronary circulation in the cath-lab. We
found the device to be effective in this patient group and we look
forward to using this technology for other applications in our cath-lab,
such as for patients presenting acute myocardial infarction with
hemodynamic instability,” said Dr. J.P.S. Henriques, Cardiologist
at the Academic Medical Center in Amsterdam.
PCIs encompass a variety of procedures that take place in the catheterization
lab to treat occluded or narrowed vessels that supply blood to the
heart. Historically, intra-aortic balloon pump (IABP) counterpulsation
has been used extensively to support patients that are at high risk
for mortality and morbidity when undergoing these PCI procedures.
However, because IABP does not actively unload the heart, it requires
a minimum of cardiac function to be effective. It also requires
a stable cardiac rhythm. In the case of blood pressure collapse
during high-risk PCI, for example, IABP support is unlikely to reverse
shock and restore normal hemodynamics. IMPELLA RECOVER LP 2.5 actively
unloads the heart and, therefore, better serves these patients in
the event of major procedural complications, such as abrupt vessel
occlusion or blood pressure collapse.
The IMPELLA RECOVER LP (Left Percutaneous) 2.5 can deliver in excess
of 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 through the femoral
artery. The IMPELLA RECOVER technology is CE marked in Europe and
has been used in European centers to support more than 500 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 effectively support patients in
the cath-lab, during minimally invasive yet high-risk procedures,
such as high-risk stent placement.
“The positive results of this study reflect the success and
performance we have demonstrated with our IMPELLA RECOVER 2.5 in
Europe and it provides cardiologists with key data supporting the
benefits of using IMPELLA for minimally invasive circulatory support,”
said Michael R. Minogue, Chairman, CEO and President of ABIOMED.
“We see a strong global need for this technology with particularly
high demand in the United States.”
The American Journal of Cardiology® is an independent journal
designed for cardiovascular disease specialists and internists with
a subspecialty in cardiology throughout the world. AJC is an independent,
scientific, peer-reviewed journal of original articles.
ABOUT THE IMPELLA® RECOVER® LP 2.5
The RECOVER LP 2.5 is a minimally invasive ventricular unloading
catheter, which is inserted percutaneously via the femoral artery
into the left ventricle. Up to 2.5 liters of blood per minute are
delivered by the pump from the left ventricle into the ascending
aorta, providing the heart with active support in critical situations.
A large percentage of patients with acute myocardial infarction
require such temporary mechanical support in order to survive. The
RECOVER LP 2.5 can be inserted quickly and provides efficient cardiovascular
support. The RECOVER LP 2.5 can be implanted for up to five days.
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 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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