IRVINE, Calif., July 21, 2005 /PRNewswire-FirstCall via COMTEX/ -- 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.
SOURCE Micro Therapeutics, Inc.
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.