Jan. 25, 2007 — ev3 Inc. has announced FDA approval of the PROTÉGÉ RX Carotid Stent, which, when used in conjunction with ev3’s SpideRX Embolic Protection Device, is indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery.
The FDA approval was supported by the CREATE (Carotid Revascularization with ev3, Inc. Arterial Technology Evolution) Trial demonstrating the safety and effectiveness of the PROTÉGÉ stent in combination with the SPIDER Embolic Protection Device. Gary Ansel, M.D., Riverside Hospital, Columbus, Ohio, and Robert Safian, M.D., William Beaumont Hospital, Royal Oak, Mich.,
were the national co-principal investigators for the trial.
PROTÉGÉ RX is available in both straight and tapered stent configurations providing a variety of device options to address a broad range of patient anatomy present in carotid artery disease. The “rapid exchange” platform, the company says, allows for a single physician to operate the device as compared to “over the wire” designs that require multiple operators. The SpideRX Embolic Protection Device is the only available distal filter embolic protection device that permits physicians to use their guide wire of choice and is cleared by the FDA for use in both carotid arteries and saphenous vein grafts.
For further information, visit www.ev3.net.