The XIENCE V® Everolimus Eluting Coronary Stent System Instructions for Use
Table of Contents
PRODUCT DESCRIPTION Device Component Description Drug Component Description Everolimus Inactive Ingredients – Non-erodible Polymer Product Matrix and Everolimus Content
INDICATIONS
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS General Precautions Pre- and Post-Procedure Antiplatelet Regimen Multiple Stent Use Brachytherapy Use in Conjunction with Other Procedures Use in Special Populations Pregnancy Lactation Gender Ethnicity Pediatric Use Geriatric Use Lesion/Vessel Characteristics Drug Interactions Immune Suppression Potential Lipid Elevation Potential Magnetic Resonance Imaging (MRI) Stent Handling Stent Placement Stent Preparation Stent Implantation Stent System Removal Post-Procedure
DRUG INFORMATION Mechanism of Action Pharmacokinetics of the XIENCE V Everolimus Eluting Coronary Stent Interactions with Drugs or Other Substances Carcinogenicity, Genotoxicity, and Reproductive Toxicity EL2066216 (1/28/10) Page 1 of 60 Pregnancy Lactation
XIENCE V SPIRIT FAMILY OF CLINICAL TRIALS SPIRIT III Pivotal Clinical Trial SPIRIT III Randomized Clinical Trial (RCT) SPIRIT III US mm Arm SPIRIT II Supportive Clinical Trial SPIRIT FIRST Randomized Clinic