| Expected
to Fuel Increased Utilization of ABIOMED Recovery Solutions in Largest
European Markets
Danvers, Mass., February 3, 2006—ABIOMED,
Inc. (NASDAQ: ABMD) today announced that the governmental authority
for reimbursement in Germany (InEK) has granted the highest approval
level available for ABIOMED's IMPELLA® RECOVER® Devices.
The new German reimbursement standard will apply to ABIOMED's
IMPELLA Recover® LP 2.5, the IMPELLA Recover® 5.0, the IMPELLA
Recover ® RD, and the IMPELLA Recover ® LD which are available
in Europe under the CE Mark and are investigational in the United
States. The Company also announced that it has recently received
product registration approval in France and has now commenced shipment
of IMPELLA technologies to customers in this country. Germany and
France represent the largest circulatory assist markets in Europe.
German reimbursement is critical for healthcare market adoption
of new technologies as it allows hospitals to provide advanced care
to their patients in a cost effective manner. Hospitals in Germany
are required to negotiate the reimbursement of advanced technologies,
medical treatments, and patient related procedural expenses directly
with the insurance companies. ABIOMED received a status 1 rating,
the highest available, for the Impella technology to support these
negotiations and future reimbursement with the German government
authorities. Successful registration of Impella products in France
provides a new opportunity for sales of ABIOMED's full IMPELLA
product line in the second largest market in Europe.
"We are focused globally on cost-effective solutions for
acute heart failure and our products offer life saving options for
the number one cause of death and the number one cost to global
healthcare systems" said Michael R. Minogue, Chairman, CEO
and President of ABIOMED.
The Company has added dedicated resources for reimbursement and
economic benefit analysis in markets around the world to help accelerate
patient access to technology.
ABOUT THE IMPELLA RECOVER DEVICES
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 a temporary mechanical support system 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 5 days.
The Recover® LP 5.0 is a ventricular unloading catheter, which
is placed via a femoral artery cut-down into the left ventricle.
Once in place, up to 5 liters of blood per minute is pumped from
the left ventricle into the ascending aorta - actively unloading
the heart. The CE Marked Recover® LP 5.0 has been used in European
centers to support patients with post-cardiotomy failure to wean,
post PCI, myocarditis, cardiogenic shock or as a bridge-to-next
decision.
ABIOMED's IMPELLA Recover Devices also include the Recover
® RD, the smallest right ventricular unloading catheter; and
the Recover ® LD, the smallest left ventricular unloading catheter.
These CE Marked devices are surgically implanted and can provide
longer duration support. The IMPELLA Recover ® RD is implantable
and can deliver up to 6.0 liters of blood per minute from the right
atrium via the outlet graft to the pulmonary artery. The Recover
® LD is surgically implanted via the aorta into the left ventricle
and delivers up to 5.0 liters of blood per minute into the ascending
aorta. These devices can be used in combination to provide temporary
bi-ventricular support in an effort to recover the natural function
of a patient's heart.
IMPELLA® RECOVER® products are investigational devices
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:
Daniel Sutherby
ABIOMED, INC.
Chief Financial Officer
(978) 646-1812
ir@abiomed.com
Liza Heapes
ABIOMED, INC.
Media Relations
(978) 646-1668
mediarelations@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.
###
|