| Danvers,
Mass., August 2, 2005—ABIOMED, Inc. (NASDAQ: ABMD)
today announced that the Centers for Medicare and Medicaid Services
(CMS) has increased reimbursement for external ventricular assist
devices (VADs) with successful recovery of the native heart. This
change impacts ABIOMED’s AB5000 and BVS 5000 devices in procedures
with both implant and explant reimbursement codes, which will now
map to DRG 103. This change will go into effect on October 1, 2005.
“We believe the best option for a patient in acute heart
failure is to be able to return home with his or her native heart,”
stated Michael R. Minogue, Chairman, President and CEO of ABIOMED.
“Our technology is used worldwide to support patients as they
recover the natural function of their heart. These changes in DRG
assignment remove a financial challenge for hospitals to support
a CMS patient for 30 days or more in order to increase the likelihood
for recovery. We applaud CMS for their extensive data analysis,
openness to review new advanced technology benefiting their patients
and focus on prevention-based care.”
The CMS Inpatient Prospective Payment System (IPPS) determines
the amount a hospital will be reimbursed for procedures during a
single patient stay. The reimbursement rate for DRG 103 represents
an approximate 70 percent increase vs. previous rates when a patient
is recovered. CMS has previously stated goals to improve healthcare
through the use of evidence based medicine, focus on preventative
care and the need to support introduction of new technologies.
Major insurance carriers currently reimburse for ventricular assist
devices used for recovering the patient’s native heart. The
recent changes made by CMS further support the need for increased
focus on recovery as prevention-based care that can reduce the excess
demand for heart transplants or chronic cardiac device support.
With a continued focus on recovery, ABIOMED’s Partnership
in Healthcare support agreements leverage Six Sigma analysis to
assist customers to improve patient outcomes.
More information is available on the CMS Website at www.cms.hhs.gov/providers/hipps/default.asp?.
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
approved by the FDA for the recovery of the natural heart.
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 BVS 5000
The BVS 5000 was approved by the FDA in 1992 as the first heart-assist
device for use in patients who experience heart failure after heart
surgery. It is the most widely used mechanical cardiac assist device
for patients with a potentially recoverable heart. It is now available
in more than 600 institutions throughout the world.
The BVS 5000 can support one or both sides of the failing heart.
The BVS 5000 is designed to provide short-term support and recovery
to the failing heart. The typical length of support on the BVS 5000
is approximately 7-10 days.
The disposable BVS Blood Pump is a pneumatically driven two-chambered
device that supports one side of the heart. The BVS Blood Pump is
placed external to the patient. The device takes over the pumping
function of the heart to allow the heart to rest and potentially
recover. The blood is re-routed from the heart to the pump and then
back to the heart through its normal course of flow.
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.
Communications Specialist
(978) 646-1668
mediarelations@abiomed.com
Investor Relations Contact:
Rx Communications Group, LLC
Melody Carey
(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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