The Cordis ANGIOGUARD® RX Emboli Capture Guidewire System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5mm (see Instructions for Use for basket/vessel sizing).
- Patients in whom antiplatelet and or anticoagulation therapy is contraindicated.
- Patients in whom the guide catheter is unable to be placed.
- Patients with uncorrected bleeding disorders.
- Patients with known allergies to nitinol.
- Lesions in the ostium of the common carotid artery.
- Only physicians who have received appropriate training for carotid stenting and who are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device.
- The safety and effectiveness of this device as an emboli protection system has not been established in the coronary, cerebral, or peripheral vasculature, other than carotid arteries.
- The safety and efficacy of the ANGIOGUARD® RX Guidewire System have not been demonstrated with stent systems other than the PRECISE® Stent System.
- Overstretching of the artery may result in rupture and life-threatening bleeding.
- Patient ACT of >300 seconds needs to be maintained during ANGIOGUARD® RX Guidewire System deployment.