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Breaking Artificial Heart is First-Ever to Come Before FDA Review
DANVERS, Mass. (April 20, 2005) - ABIOMED, Inc.
(NASDAQ: ABMD) a manufacturer of products for circulatory care and
support, today announced that the U.S. Food and Drug Administration
(FDA) will convene an expert panel of cardiovascular surgeons and
cardiologists to review the groundbreaking technologies and clinical
trial data behind the AbioCor artificial heart. The special expert
review panel is expected to decide on June 23, 2005 on the potential
approval for AbioCor under a Humanitarian Device Exemption (HDE).
This is the first-ever completely self-contained artificial heart
to come before the FDA for review.
The technology behind the AbioCor artificial heart is the result
of over 20 years of design, research, and testing conducted by ABIOMED,
Inc. and its collaborators, with the support of the National Heart,
Lung and Blood Institute. The AbioCor is driven by a high-precision
electro-hydraulic system pumping seamlessly to drive consistent
and stable circulation, similar to a patient's natural heart. This
device also contains a microprocessor chip and internal diagnostics
that continuously monitor patient vitals. The complete system is
powered by a small external battery that transmits power across
the skin without wires, eliminating risk of infection and allowing
for a better quality of life. Additionally, with the use of the
internal battery, which lasts over 60 minutes, patients can enjoy
swimming or bathing. The AbioCor is truly a unique break-through
product with over 50 patents, numerous trade secrets and over $100
million invested in its development.
Although tens of thousands are in need, only about 2,000 people
in the U.S. will be able to receive donor hearts every year. This
consistent shortage in the supply of donor hearts in the U.S. demonstrates
the need for an alternative to heart transplantation. Under the
HDE application, up to four thousand patients a year who are not
eligible for a heart transplant, will have the potential to be eligible
for an AbioCor. These patients currently have no other options available
and are suffering from bi-ventricular heart failure. Subject to
HDE approval, ABIOMED will select 15 centers worldwide to perform
the procedure with the AbioCor.
"The elegance of the AbioCor technology makes this device
groundbreaking and represents a new level of science never before
seen in heart treatment," stated Dr. Laman Gray, Professor
of Surgery and Director of the Division of Thoracic and Cardiovascular
Surgery at the University of Louisville School of Medicine. "We
are very excited to have the AbioCor reviewed by a FDA panel comprised
of industry experts, as they can truly appreciate the level of medical
advancement that the AbioCor brings to modern patient care."
"We believe that this panel will give us immediate exposure
to the experts in heart failure, as well as the general public.
Our surgeons are very passionate about this technology and look
forward to having the ability to offer this solution under an HDE
to their patients," commented Michael R. Minogue, Chief Executive
Officer and President.
ABIOMED initially submitted the AbioCor for marketing approval
under HDE to the FDA in September 2004. Approval under an HDE would
make the AbioCor commercially available to treat a defined subset
of not more than 4,000 irreversible end-stage heart failure patients.
The AbioCor is designed to sustain the body's circulatory system
and to extend the lives of patients who would otherwise die of heart
failure. Its unique design allows it to be totally implanted within
the body. Unlike the artificial hearts of the past, patients are
not tethered to a large, air-pumping console nor do they have wires
or tubes piercing their skin. The AbioCor 2 is currently being implanted
in animal studies and has the potential to last longer with a 35
percent reduction in size.
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. The Company’s AbioCor®
Implantable Replacement Heart is the subject of an initial clinical
trial being conducted 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.
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Media Contact:
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
Investor Relations Contact:
Jane Petrino
Noonan Russo
(212) 845-4274
jane.petrino@eurorscg.com
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