The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL, XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTILINK VISION® or MULTI-LINK MINI VISION® Delivery System
The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.
The XIENCE Sierra stent system is contraindicated for use in:
POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order) which may be associated with percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:
The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.
Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.
Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available), at eifu.abbottvascular.com or at Manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Tests performed by and data on file at Abbott. Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos and videos on file at Abbott.
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XIENCE Alpine, XIENCE PRIME, and XIENCE Sierra are trademarks of the Abbott Group of Companies. Cypher is a trademark of Cordis, a Cardinal Health Company. EluNIR is a trademark of Medinol Ltd. Orsiro is a trademark of Biotronik. Pebax is a trademark of Arkema France. Resolute and Resolute Onyx are trademarks of Medtronic Inc. Synergy and TAXUS are trademarks of Boston Scientific Corporation or its affiliates.
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