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雅培xience v依维莫司洗脱支架系统使用说明书.pdf


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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)
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Pregnancy
Lactation

OVERVIEW OF CLINICAL STUDIES

ADVERSE EVENTS
Observed Adverse Events
Stent Thrombosis Definitions
Potential Adverse Events

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

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  • 页数60
  • 收藏数0 收藏
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  • 上传人qucheng26364
  • 文件大小1.74 MB
  • 时间2021-11-23
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