Micro Therapeutics, Inc. (MTI) (NASDAQ:MTIX), Irvine, Calif., 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.
For more information call 949/837-3700.
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