Drives Abiomed's IAB, BVS and AB5000 Circulatory Support Systems
Abiomed Enters Established $200 Million Intra-Aortic Balloon
Market
DANVERS, Mass.--(BUSINESS WIRE)--Dec. 19, 2007--Abiomed, Inc.
(NASDAQ: ABMD) today announced that it has received approval from the
U.S. Food and Drug Administration (FDA) for U.S. commercial
distribution of the Company's combination iPulse(TM) Circulatory
Support System. The iPulse drives Abiomed and other manufacturer's
intra-aortic balloons (IAB), Abiomed's BVS(R) 5000 and AB5000(R)
Ventricular Assist Devices (VAD), as well as new products Abiomed may
offer in the future. These products are designed to treat patients
suffering from acute heart failure by offering various levels of
cardiac support, whether minimal, moderate, or full bi-ventricular, to
potentially recover the patient's native heart. The iPulse is the
first console with the capability to provide either VAD or IAB support
in the catheterization lab and surgery suite.
"This is an important milestone for Abiomed and an opportune time
to be entering the $200 million IAB market," said Michael R. Minogue,
Chairman, CEO and President of Abiomed. "We believe the iPulse will
create new opportunities in open heart hospitals and help fuel growth
in our AB5000 disposables."
There are an estimated 160,000 IAB's used globally each year with
approximately 110,000 annual U.S. procedures. Over 1,000 open heart
hospitals, which include approximately 100 transplant hospitals, could
potentially use an IAB today as their initial level of circulatory
support in the U.S. Based on Abiomed's internal testing during 510(k)
clearance of its IAB, the Company believes its IAB has the fastest
inflate-deflate time, and best performance relative to abrasion
resistance and triggering. The iPulse should be a more cost-effective
system for heart hospitals by supporting procedures with associated
Medicare reimbursement that extends across four diagnostic related
groups (DRGs) ranging from approximately $20,000 to $215,000 per
patient stay.
The current installed base of Abiomed's AB5000 Circulatory Support
System, prior to the approval of the iPulse, is comprised of
approximately 50% of the U.S. transplant hospitals and approximately
20% of the U.S. open heart hospitals. Abiomed's iPulse is also
approved in Europe under CE-mark.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading
provider of medical devices that provide circulatory support to acute
heart failure patients across the continuum of care in heart recovery.
Our products are designed to enable the heart to rest, heal and
recover by improving blood flow and/or performing the pumping of the
heart. For additional information please visit: www.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 its most recently filed annual report on Form 10-K and
quarterly report on Form 10-Q. 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.
CONTACT: Abiomed, Inc.
Daniel J. Sutherby, 978-646-1812
Chief Financial Officer
ir@abiomed.com
or
Brodeur, for Abiomed
Steve Marchant, 617-587-2864
Media Relations
smarchant@brodeur.com
SOURCE: Abiomed, Inc.