ACC: ev3 Stent Cleared for Patients at Risk of Adverse Events from CAD Surgery


March 23, 2007

When used in conjunction with the ev3 embolic protection device, ev3’s PROTÉGÉ RX Carotid Stent has been FDA cleared for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery. The cleatance was supported by the CREATE (Carotid Revascularization with ev3 Inc. Arterial Technology Evolution) Trial demonstrating the safety and effectiveness of the PROTÉGÉ Stent and the SPIDER Embolic Protection Device when used together to treat carotid artery disease patients at risk for stroke and also at high-risk for adverse events from surgery.

The 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 allows for a single physician to operate the device as compared to “over the wire” designs that require multiple operators.