Micro Therapeutics (NASDAQ:MTIX)
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Micro Therapeutics Announces FDA Approval of Onyx(R) for the
Treatment of Brain Vascular Disorder
IRVINE, Calif., July 21 /PRNewswire-FirstCall/ -- Micro Therapeutics, Inc.
(MTI) (NASDAQ:MTIX) today announced that it has received pre-market application
(PMA) approval from the U.S. Food and Drug Administration (FDA) to commercialize
its Onyx(R) Liquid Embolic System (Onyx) for the treatment of arterio-venous
malformations (AVMs), a vascular disorder in the brain. MTI expects to
commence immediately a controlled introduction of Onyx in the United States
through its direct sales force. Onyx has been under development by MTI since
1995 and has been distributed in international markets since 2002 by MTI's
majority stockholder, ev3 Inc. (NASDAQ:EVVV).
Arterio-venous malformations (AVMs) are blood vessel networks that abnormally
connect arteries to veins. As a result of high blood flow and pressure
imbalances, AVMs in the brain are at risk of hemorrhage, or rupture, which can
lead to stroke, severe disability and even death. Treatment options for AVMs
include catheter-based therapies, surgery, radiation therapy, or a combination
of these treatments. Catheter-based treatments involve the delivery of embolic
materials to occlude, or block, the abnormal blood vessels comprising the AVM.
Onyx is a liquid embolic material that is delivered by neurovascular
specialists through MTI's proprietary micro catheters directly into a vascular
defect, such as a brain aneurysm or AVM, in a very controlled manner. After
delivery of the embolic material, the liquid quickly transforms into a solid
polymer cast, thereby sealing off the vessels in the AVM from blood flow and
reducing the risk of rupture. In the United States, Onyx is indicated for use
in the pre-surgical embolization of brain AVMs. Endovascular embolization can
reduce the size and vascularity of the AVM, thereby facilitating safer and
easier surgical resection.
Gary Duckwiler, M.D., principal investigator in the pivotal clinical study of
Onyx for AVMs, commented, "Onyx represents an important new cerebral AVM
treatment option with its ability to facilitate a more deliberate and
controlled embolization procedure." Dr. Duckwiler is the Director of
Neuroradiology Fellowship Program, Division of Interventional Neuroradiology,
and Professor of Radiology, UCLA Department of Radiological Sciences.
About Micro Therapeutics, Inc.
Micro Therapeutics develops, manufactures and markets minimally invasive
medical devices for the diagnosis and treatment of vascular disease. The
company is focused on catheter-based, or endovascular, technologies for the
minimally invasive treatment of neurovascular disorders of the brain associated
with stroke. MTI's products include: the Tetris and NXT lines of embolic coils;
the Onyx(R) liquid embolic; and a range of access and delivery products that
include micro delivery catheters, balloon catheters, and guidewires.
Statements contained in this press release that are not historical information
are forward-looking statements as defined within the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ materially
from those projected or implied. Such potential risks and uncertainties
relate, but are not limited, to, in no particular order: product demand and
market acceptance, the impact of competitive products and pricing, and success
of clinical testing. More detailed information on these and additional factors
that could affect Micro Therapeutics, Inc.'s operating and financial results are
described in the company's Forms 10-Q, 10-KSB, and other reports, filed or to be
filed with the Securities and Exchange Commission. Micro Therapeutics, Inc.
urges all interested parties to read these reports to gain a better
understanding of the many business and other risks that the company faces.
Additionally, Micro Therapeutics, Inc. undertakes no obligation to publicly
release the results of any revisions to these forward-looking statements, which
may be made to reflect events or circumstances occurring after the date hereof
or to reflect the occurrence of unanticipated events.
DATASOURCE: Micro Therapeutics, Inc.
CONTACT: Thomas C. Wilder of Micro Therapeutics, Inc., +1-949-837-3700;
or Rob Whetstone, or Robert Jaffe, both of PondelWilkinson Inc.,
+1-310-279-5963, for Micro Therapeutics, Inc.