Products
Express²® Coronary Stent System
PRESCRIPTIVE INFORMATION
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
The Express2 Monorail/Express2 OTW are indicated for improving coronary luminal diameter in the following: Patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries (length <18mm) with a reference vessel diameter of 3.0 to 5.0mm. Treatment of abrupt or threatened abrupt closure (AC/TAC) in patients with failed interventional therapy in lesions in native coronary arteries of 2.25 to 5.0mm (inclusive) in diameter and <30mm long. Long-term outcome (beyond 6 months) for this permanent implant is unknown at present.
Contradictions
Patients in whom antiplatelet and/or anticoagulant therapy is contraindicated. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Warnings
The device carries an associated risk of subacute thrombosis, vascular complications, and/or bleeding events. Therefore, patients should be carefully selected. Person allergic to 316L stainless steel may suffer an allergic reaction to this implant. The safety and effectiveness of the use of the Express Stent in the treatment of restenotic lesions have not been established. Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stented portion and may cause acute closure of the vessel requiring additional intervention (e.g. CABG, further dilation, placement of additional stents, or other).
Potential Adverse Effects
Aneurysm, arrhythmias, bleeding complications, death, distal emboli, emergent CABG, myocardial infarction, myocardial ischemia, occlusion, stent delivery failures, target lesion revascularization, thrombosis, vascular complications, vessel dissection. Prior to use, please see the full Instructions for Use supplied with these devices.
Cautions
Federal (USA) law restricts this device to sale by or on the order of a physician.
Trademark
Express2, Monorail, TANDEM Architecture, TrakTip, CRIMP360, DynaLEAP, MICRO and MACRO are a trademark of Boston Scientific Corporation or its affiliates.
