| ABIOMED
to Open French Office for Direct Sales and Clinical Support for Customers
Danvers, Mass., and Aachen, Germany May 22, 2006—ABIOMED,
Inc. (NASDAQ: ABMD) today announced that the French regulatory agency
for medical devices, the Agence Française de Sécurité
Sanitaire des Produits de Santé (AFSSAPS) has granted approval
of the AB5000™ Circulatory Support System. France represents
one of the largest medical device markets in Europe. All of ABIOMED’s
Circulatory Support Systems including the IMPELLA products are now
available in France, providing French patients in acute heart failure
with access to life-saving circulatory support. In addition, ABIOMED
announced plans to open an office in Paris to provide French customers
with direct customer service, and sales and clinical expertise as
they incorporate Ventricular Assist Device (VAD) Recovery Programs
into standard clinical practice.
The AB5000 is a VAD that was designed to rest and recover a patient’s
heart following such events as cardiogenic shock resulting from
myocardial infarction, myocarditis, postpartum cardiomyopathy, ventricular
septal defect, refractory arrhythmias, failed heart transplants,
right ventricular assistance with implantable LVAD (Left Ventricular
Assist Device), and postcardiotomy cardiogenic shock (PCCS). The
ABIOMED® AB5000™ System also allows patients to walk with
the support of the console.
“We are excited by the momentum in Europe overall and also
with this new access to the French market,” stated Michael
R. Minogue, Chairman, President and CEO of ABIOMED. “The U.S.
clinical data supporting heart recovery using our technology is
extensive and we are seeing increased utilization worldwide. Our
plan for a new office in France demonstrates our strong commitment
to work closely with our customers and clinical leaders in France
to assist in the development of Recovery Programs for their patients.”
ABIOMED has exclusive labeling in the United States for recovery
indications through its AB5000 and BVS 5000 platforms. The Company’s
global sales and clinical teams now total more than 45 individuals
and the Company announced recently its intention to hire 2-4 additional
sales and clinical professionals globally per quarter in fiscal
2007.
ABOUT THE AB5000™ Circulatory Support System
The AB5000 was FDA approved in September 2003 to provide 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 the BVS 5000 are the only devices
with recovery labeling in the United States.
The AB5000™ Ventricle, a major component of the AB5000 Circulatory
Support System, is a pneumatically driven blood pump. The sterile,
disposable Ventricle provides circulatory support in the presence
of left-, right-, or both-sided heart failure. The Ventricle is
located next to the body (paracorporeal) and can take over the pumping
function of the natural heart. Assisted by vacuum, blood flows from
the native heart into the AB5000 Ventricle bladder. The bladder,
which holds about 100 cc of blood, fills and empties much like the
natural heart. Connection of the Ventricle to the patient is accomplished
by connecting the pump to cannulae, or tubes, implanted in the patient's
heart. These tubes pass through the patient’s skin and connect
directly to the AB5000™ Console.
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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