| Patients
with Heart Attack Followed by Shock Provided with Timely Support Able
to Recover and Avoid Heart Transplant
Danvers, Mass., and Washington, DC, 17th Annual Transcatheter
Cardiovascular Therapeutics (TCT) Meeting, Booth #254, October
17, 2005-ABIOMED, Inc. (NASDAQ: ABMD), a leading developer,
manufacturer and marketer of medical products designed to assist
or replace the pumping function of the failing heart, today announced
data presented at the 17th Annual TCT Meeting on its AB5000 Circulatory
Support Device. A multi-center study presented by Dr. Mark Anderson,
Associate Professor of Surgery and Chief Section of Cardiac Surgery
at Robert Wood Johnson University Hospital in New Brunswick, New
Jersey, found that patients with Acute Myocardial Infarction (AMI
or heart attack) followed by cardiogenic shock could recover the
natural function of their heart when given AB5000 circulatory support
for an average of 31 days.
The presentation entitled, "Mechanical Circulatory Support
Improves Recovery Outcomes in Profound Cardiogenic Shock Post Acute
Myocardial Infarction," studied patients at 26 U.S. Centers.
Of the patients who were able to survive this traumatic coronary
event, 67 percent were able to fully recover their heart, avoiding
heart transplant.
It is estimated that there are 865,000 patients annually in the
U.S. with acute myocardial infarction. Of those, roughly 7-10 percent
suffer cardiogenic shock, meaning that the heart fails to pump an
adequate amount of blood to sustain a good perfusion of the other
organs. Patients with AMI complicated by cardiogenic shock often
have high mortality rates, upwards of 50 percent, despite the majority
being otherwise healthy and undergoing measures such as coronary
revascularization, inotropic drugs and intra-aortic balloon pump
therapy. For many patients, these measures further weaken the heart
in an effort to force it to increase its function in order to provide
blood flow for vital organ function.
"I have found that by utilizing the AB5000, we are able to
recover our patientsÙ hearts and send them home without a
transplant, which can be costly and expose these patients to a variety
of other problems," said Dr. Anderson. "By providing circulatory
support, we can allow an injured heart time to rest. If given enough
time to rest, the cells of the heart can repair themselves. It is
truly rewarding to see this happen."
"Dr. AndersonÙs presentation at this widely attended
meeting further supports ABIOMEDÙs mission to help support
and recover patientsÙ hearts. His work with VAD technology
puts him at the forefront of a movement to help patients recover
and continue to enjoy the quality of life with their own natural
heart," said Michael R. Minogue, Chairman, CEO and President
of ABIOMED. "New reimbursement guidelines from CMS encourage
recovery as an outcome and we expect to see this trend continue."
ABOUT THE AB5000Ǣ 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 patientÙs 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 is a major component of the AB5000Ǣ
Circulatory Support System and 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
AB5000Ǣ 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 patientÙs skin and connect directly
to the AB5000 Console.
ABOUT ABIOMED
Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced "ABÙ-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 AB5000Ǣ
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®
RecoverǢ minimally invasive cardiovascular support systems
under CE Mark approval. The CompanyÙs 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
Investor Relations Contact:
Melody Carey
Rx Communications Group, LLC
(917) 322-2571
mcarey@rxir.com
FORWARD-LOOKING STATEMENTS
This Release contains forward-looking statements, including statements
regarding development of ABIOMEDÙs existing and new products,
the CompanyÙs progress toward commercial growth, and future
opportunities. The CompanyÙs 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 CompanyÙs 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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