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ev3 Receives CE Mark Approval for Tapered Stents for Carotid
Stenting Procedures
New Stent Designed to Better Fit Carotid Arteries; U.S. Clinical Trial Well
Under Way
PLYMOUTH, Minn., Aug. 26 /PRNewswire/ -- ev3 Inc., a privately held
endovascular medical device company, has received CE Mark commercial approval
for use of its Protege(R) GPS(TM) Nitinol Self-Expanding Tapered Stent for
treatment of carotid artery disease. This stent is a minimally invasive
procedure to open blockages in carotid arteries and prevent stroke. The
carotid arteries deliver the primary blood supply to the head and brain. The
product is commercially available in Europe.
"Use of the Protege Tapered Stent in conjunction with innovative embolic
protection systems, like our new SpideRX(TM) device, offers a complete system
for carotid stenting and embolic protection," said James Corbett, ev3 president
and chief executive officer. "Our Protege Tapered Stent is an excellent
example of ev3's commitment to developing technologies for unmet or underserved
clinical needs." ev3 received CE Mark approval for the SpideRX(TM) Embolic
Protection Device in June.
Carotid artery blockage typically occurs at the junction of the common and
internal carotid arteries. Consequently, a traditional cylindrical stent may
not provide the ideal fit for transition from the larger common carotid to the
smaller internal carotid artery. The Protege(R) GPS(TM) Tapered Stents are
designed to provide a more appropriate fit to the varying diameters of these
diseased vessels.
"Restoring flow to the diseased carotid artery is the primary objective of the
intervention," said Gary Ansel, M.D., Riverside Methodist Hospital, Columbus,
Ohio, national co-principal investigator of the CREATE trial. "A stent that
conforms well to the vessel wall and more closely matches the vessel diameter
is potentially a significant improvement in stent design."
CREATE is a U.S. investigational clinical trial that involves use of the
Protege(R) GPS(TM) Stent and SPIDER(TM) Embolic Protection Device to treat
patients with carotid artery disease. The Protege tapered stent has been well
accepted in this fast-enrolling trial. Forty U.S. hospitals are participating
in the trial and will enroll approximately 420 patients who have blockages
within their carotid arteries and are at high risk for an open surgical
procedure. The CREATE trial is expected to be completed in the 2004 third
quarter. ev3 plans to submit trial data in an application to the Food and Drug
Administration (FDA) for marketing clearance of the carotid artery application
of these devices in the United States.
Carotid endarterectomy surgery has been the most common procedure for treating
atherosclerosis, but carotid stenting is quickly gaining favor among
interventional physicians. Blockages in the carotid arteries caused by
atherosclerosis, a hardening and thickening of the vessels, are a significant
risk factor for stroke. According to the World Health Organization, stroke is
the second most common cause of death, and a major cause of disability in
adults world-wide. Strokes cause over five million deaths each year in both
developing and developed countries.
About the Protege GPS Stents
Protege(R) GPS(TM) Nitinol Self-Expanding Stents and Tapered Stents have CE
Mark approval for placement into the carotid artery, designed to keep the
vessel open and allow increased blood flow. Both products incorporate
proprietary design elements to ensure precise stent placement and provide
optimal visibility on x-rays. The Protege GPS is made of nitinol, an alloy
commonly used in stents. The Protege Stent is cleared for malignant biliary
(bile duct) use in the United States and also has CE Mark approval for
peripheral vascular use in Europe.
About ev3
ev3 Inc., privately held and based in Plymouth, Minnesota was founded in 2000.
ev3 Inc. is a global medical device company that is focused on innovative
endovascular technologies for the minimally invasive treatment of coronary,
neurovascular, and peripheral vascular diseases and disorders. In 2001, ev3
established a strategic relationship with Micro Therapeutics, Inc.
(NASDAQ:MTIX), a leader in the market for catheter-based neurovascular devices.
ev3 Inc. and Micro Therapeutics, Inc., are majority owned by ev3 LLC, a
private equity partnership organized by Warburg Pincus and the Vertical Group,
two of the most successful institutional investors in the medical device
industry. More information about ev3 and its products can be found at
http://www.ev3.net/ .
** The SPIDER(TM) Embolic Protection device is an investigational device
limited by federal (U.S.) law to investigational use in the United States. For
carotid use, the Protege(R) GPS(TM) Stent is limited by federal (U.S.) law as
"investigational only" in the United States. The SpideRX(TM) and Protege(R)
GPS(TM) Tapered Devices are not available in the United States.
Protege, GPS, SPIDER, SpideRX and ev3 are trademarks of ev3 Inc.
DATASOURCE: ev3 Inc.
CONTACT: Cheryl Newell, CFO of ev3 Inc., +1-763-398-7000,
; or Nancy A. Johnson, +1-612-455-1745, ,
or Marian Briggs, +1-612-455-1742, , both of Padilla Speer
Beardsley
Web site: http://www.ev3.net/