ev3 Receives CE Mark Approval for Tapered Stents for Carotid Stenting Procedures
26 Agosto 2004 - 1:33PM
PR Newswire (US)
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/
Copyright
Micro Therapeutics (NASDAQ:MTIX)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
Micro Therapeutics (NASDAQ:MTIX)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024
Notícias em tempo-real sobre Micro Therapeutics (MM) da NASDAQ bolsa de valores: 0 artigos recentes
Mais Notícias de Micro Therapeutics (MM)