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FDA GRANTS MARKETING CLEARANCE TO EV3 FOR PROTEGE GPS.


ev3 Inc., Plymouth, Minn., a privately held endovascular medical device company, has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the use of the company's Protege(R) GPS(TM) Nitinol Self-Expanding Long Stents to treat malignant biliary strictures. These stents are used during a minimally invasive procedure to open strictures and blockages. The product will be available in the U.S. market in October. The Protege GPS Long Stents is also expected to receive CE Mark approval for use in Europe to treat biliary strictures and peripheral vascular disease, including the iliac artery.

"The Protege GPS Long Stents broaden ev3's self-expanding stent product line to address additional unmet clinical needs," said Jim Corbett, ev3 president and chief executive officer. "With the introduction of longer- length stents, ev3 now offers the widest range of self-expanding stents."

The new Protege GPS Long Stents will be offered in lengths up to 150mm. Using one stent, rather than several shorter stents, simplifies the placement procedure and reduces the risk of complications. All ev3 Protege stents 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.

About ev3

ev3 Inc., privately held and based in Plymouth, Minnesota, was founded in 2001. 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.

For more information, visit http://www.ev3.net or call +1-763-398-7000.

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Publication:Biotech Equipment Update
Date:Dec 1, 2004
Words:318
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