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FDA APPROVES EV3'S PROTEGE RX CAROTID STENT.

Publication: Biotech Equipment Update
Publication Date: 01-MAR-07
Format: Online
Delivery: Immediate Online Access

Article Excerpt
ev3 Inc., Plymouth, Minn., (NASDAQ:EVVV) has announced U.S. Food and Drug Administration approval of the PROTEGE(R) RX Carotid Stent. This stent, when used in conjunction with the ev3 embolic protection device, is indicated for the treatment of carotid artery disease in patients who are at in...

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...high-risk for adverse events from carotid artery surgery. ev3's SpideRX(R) Embolic Protection Device was previously FDA cleared for carotid use February 2006.

The FDA approval was supported by the CREATE (Carotid Revascularization with ev3, Inc. Arterial Technology Evolution) Trial demonstrating the safety and effectiveness of the PROTEGE(R) Stent and the SPIDER(TM) Embolic Protection Device when used together to...

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