| 70
percent of Survivors Recover Heart Function
DANVERS, Mass. (January 25, 2005) – ABIOMED,
Inc. (NASDAQ: ABMD) a manufacturer of products for circulatory care
and support, today provided a clinical update for the AB5000 Circulatory
Support System. Formally launched in April 2004, outcomes have continued
to improve as the system has gone into wider use. ABIOMED's ventricular
assist devices, the AB5000 and the BVS® 5000, are the only devices
approved for Bridge-to-Recovery treatment following AMI-cardiogenic
shock (shock following a heart attack). The systems are also used
to support the heart and allow for potential recovery following
other acute events including post cardiotomy cardiogenic shock (shock
following coronary bypass surgery), and viral myocarditis, a virus
that attacks the heart.
Key facts on AB5000 usage and outcomes, based on ABIOMED's voluntary
data registry:
- More than seventy percent of survivors have been able to go
home with their own hearts. In addition, recovery of kidney function
has allowed some heart patients to avoid planned kidney transplants.
- One in four patients have been transitioned from the BVS 5000
to the AB5000. This transition took place without re-opening the
chest, avoiding bleeding and other risks associated with additional
surgery to change out to other devices.
- Mean duration of support on the AB5000 is three times longer
than on the BVS5000, with many patients requiring support beyond
30 or 60 days and some beyond 90 days. In bench testing, the AB5000
Ventricle has operated nearly a year and is continuing.
- While patients are implanted with the AB5000 with the goal
of recovering the heart, there have been some instances in which,
after giving a patient's heart a full opportunity to recover,
doctors have determined that recovery will not occur. Nearly thirty
percent of survivors have received heart transplants after it
was determined that native heart function would not return; their
average duration of support on the AB5000 was nearly 40 days.
- 20 percent of all AB5000 patients were supported following
AMI-Cardiogenic shock.
- 47 percent of all AB5000 patients required support on both
sides of the heart.
- Nineteen patients have ambulated while on AB5000 support, walking
hospital grounds as well as using treadmills and stationary bicycles.
"I am very encouraged by our results with the AB5000. This
device provides adequate time, sometimes several weeks or more,
for the patient's own heart to recover from an acute cardiac event,"
said Jack Crumbley, Director of Cardiac Transplantation at the Medical
University of South Carolina. "The AB5000 allows full ambulation
and active physical therapy, while minimizing adverse events. Because
all the ABIOMED cannulae are compatible, patients rescued with the
BVS can be easily transitioned to the AB without additional surgery.
Also, the longer support time makes the AB5000 suitable for the
consideration of other options if the patient's own heart does not
recover."
ABIOMED's approved products, the BVS 5000 and AB5000, are indicated
for Bridge to Recovery. Independent studies have indicated that
the potential US caseload for Bridge to Recovery patients is 60,000
patients per year. Currently less than 1,000 patients per year actually
receive temporary support from a ventricular assist device with
the goal of recovery, even though the alternative is usually death.
"Our focus is recovering the heart, which is the best option
both for patients and the hospital," commented Michael R. Minogue,
CEO and President of ABIOMED. "We are committed to providing
not only technology leadership, but also the clinical education
and support necessary to help save lives."
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, which currently sells the BVS® 5000 Biventricular
Support System and the AB5000™ Circulatory Support System,
is the market leader in devices for the temporary support of patients
with failing but potentially recoverable hearts. In September 2004,
ABIOMED applied for initial FDA market approval for the AbioCor
Implantable Replacement Heart to treat a defined subset of irreversible
end-stage heart failure patients under a Humanitarian Device Exemption.
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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Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
Investor Relations:
Jane Petrino
Noonan/ Russo
(212) 845-4274
jane.petrino@eurorscg.com
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