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ev3 Inc. Announces FDA Approval of Onyx(R) for the Treatment of
Brain Vascular Disorder
PLYMOUTH, Minn., July 21 /PRNewswire-FirstCall/ -- ev3 Inc. (NASDAQ:EVVV)
today announced that its majority-owned subsidiary Micro Therapeutics, Inc.
(MTI) (NASDAQ:MTIX) 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 by ev3 since 2002.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050615/CGEV3LOGO )
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 ev3 Inc.
ev3 Inc. is a global medical device company focused on endovascular
technologies for the minimally invasive treatment of vascular diseases and
disorders.
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
which could affect ev3 Inc.'s operating and financial results are described in
the company's filings with the Securities and Exchange Commission, including
its Registration Statement on Form S-1. ev3 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, ev3 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.
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DATASOURCE: ev3 Inc.
CONTACT: Patrick D. Spangler, CFO, of ev3 Inc., +1-763-398-7000,