| First
U.S. Patient Successfully Treated for High-Risk Angioplasty with World’s
Smallest Ventricular Assist Device
DANVERS, Mass. (July 17, 2006)— Abiomed,
Inc. (NASDAQ: ABMD) today announced the start of the IMPELLA®
2.5 pilot study in the United States with the enrollment of the
first patient at William Beaumont Hospital in the Detroit area.
The IMPELLA 2.5 is the world’s smallest ventricular assist
device (VAD) and is currently available in Europe under the CE Mark.
The treatment involved utilizing Abiomed’s IMPELLA 2.5 minimally
invasive ventricular assist device during high-risk angioplasty,
and provided strong hemodynamic support with over 2 liters of flow
for the patient throughout the procedure. It is estimated that 5
to 10 percent of the one million U.S. angioplasty cases are considered
high-risk. In this case, the patient had previously received a bypass,
a defibrillator, had poor heart function and needed angioplasty
to open a complex lesion in the vessel supplying blood to the heart
itself. The IMPELLA 2.5 was implanted quickly and easily through
the groin, and resulted in a favorable procedural outcome for the
patient who has already been discharged from the hospital, approximately
48 hours after the procedure.
"The IMPELLA 2.5 technology is revolutionary and one of the
most exciting new products I have seen in interventional cardiology,"
stated William O’Neill, Corporate Director of Cardiology,
William Beaumont Hospital System. "The ease of insertion of
IMPELLA and its unique capability to unload the left ventricle and
enhance flow to the body improved the patient safety during this
complex, high-risk angioplasty procedure performed by Dr. Simon
Dixon."
"The device is very easy to use in the catheterization lab
environment," said Dr. Dixon. "It helps optimize the treatment
of very challenging lesions for the benefit of the patient."
"We believe IMPELLA 2.5 will change the standard of care in
cath labs worldwide, and are pleased by the positive results from
the first patient procedure in the U.S.," stated Michael R.
Minogue, Chairman, President and CEO of Abiomed.
Abiomed announced that it will conduct a conference call in the
future to outline the further details of the trial.
On May 25, 2006, the Company announced that it had received FDA
approval to commence its pilot clinical trial in the United States
for the IMPELLA 2.5 minimally invasive ventricular assist device.
The indication for use is support during high-risk angioplasty and
subsequent to the procedure, if needed, for up to five days as a
left ventricular assist device. Angioplasty, performed in the catheterization
lab, is the insertion of a catheter-guided balloon and is used to
open a narrowed coronary artery. A stent (a wire-mesh tube that
expands to hold the artery open) is usually placed at the narrowed
section. High-risk angioplasty is defined as patients undergoing
angioplasty on an unprotected left main coronary artery lesion,
or the last patent coronary conduit, and poor cardiac function.
ABOUT ABIOMED Based in Danvers, Massachusetts, Abiomed, Inc. 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 IMPELLA® 5.0 and 2.5 are investigational
devices limited by Federal Law solely to investigational use in
the United States. Other IMPELLA devices are not yet available for
sale in the United States. 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.
Contacts:
Liza Heapes
ABIOMED, INC
Media Relations
mediarelations@abiomed.com
Daniel Sutherby
ABIOMED, INC
Chief Financial Officer
(978) 646-1812
ir@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 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.
###
|