VeriFLEX™ Bare-Metal Coronary Stent System

Prescriptive Information

Indications

The VeriFLEX™ Bare-Metal Over-the-Wire and Monorail® Coronary Stent Systems are indicated for improving coronary luminal diameter in the following: Patients with symptomatic ischemic disease associated with stenotic lesions in native coronary arteries (length <28 mm) with a reference vessel diameter of 2.75 to 5.0 mm.

Contraindications

The VeriFLEX™ Stent is contraindicated for use in:

• 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.
• Patients with known allergies to stainless steel.

Warnings

• The use of this product carries the risks associated with coronary artery stenting, including subacute thrombosis, vascular complications, and/or bleeding events.
• Patients with a known hypersensitivity to 316L stainless steel may suffer an allergic reaction to this implant.

Potential Adverse Effects

Potential adverse events (in alphabetical order) which maybe associated with the use of a coronary stent in native coronary arteries include, but are not limited to: Aneurysm, Arrhythmias,Bleeding complications, Death,Distal emboli, Emergent CABG, Myocardial infarction, Myocardial ischemia, Occlusion, Perforation, Stent delivery failures, Stent embolization, Target lesion revascularization,Thrombosis, Vascular complications, Vessel dissection.

Cautions

Federal (USA) law restricts this device to sale by or on the order of a physician.

Trademark

Monorail, Bioslide, DynaLEAP, Maverick², and Veriflex are trademarks of Boston Scientific Corporation or its affiliates.

Pebax is a trademark of ATOCHEM Corporation.
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