Carotid Wallstent Monorail Endoprosthesis

Approval order statement

APPROVAL FOR THE CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS. THE DEVICE, USED INCONJUNCTION WITH THE BOSTON SCIENTIFIC EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE TREATMENTOF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY DUE TO EITHER ANATOMIC OR COMORBID CONDITIONS WHO REQUIRE CAROTID REVASCULARIZATION IN THE TREATMENT OF IPSILATERAL ORBILATERAL CAROTID ARTERY DISEASE AND MEET THE CRITERIA OUTLINED BELOW:1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND > 50% STENOSIS OF THE COMMON, INTERNAL CAROTIDARTERY AND/OR THE BIFURCATION BY ULTRASOUND OR ANGIOGRAM, OR PATIENTS WITHOUT NEUROLOGICALSYMPTOMS AND > 80% STENOSIS OF THE COMMON, INTERNAL CAROTID ARTERY AND/OR THEBIFURCATION BY ULTRASOUND OR ANGIOGRAM, AND;2) PATIENTS WITH A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THETARGET LESION.