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. , 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.
ev3 Inc.
CONTACT: Cheryl Newell, CFO of ev3 Inc., +1-763-398-7000,cnewell@ev3.net ; or Nancy A. Johnson, +1-612-455-1745, njohnson@psbpr.com ,or Marian Briggs, +1-612-455-1742, mbriggs@psbpr.com , both of Padilla SpeerBeardsley
Web site: http://www.ev3.net/