St. Jude Medical CardioMEMS CM1000, Руководство пользователя

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Contents
Description 4
Indications 5
Contraindications 5
Clinical Considerations for Patient Selection 5
Warnings 5
Precautions 6
MRI Information 7
Explant and Disposal 8
Potential Adverse Events 8
Instructions for Use 9
Personnel Training 9
Accessories 9
Package Inspection 9
Package Contents 9
Sterilization 9
Pre and Post Procedure Antiplatelet Regimen 10
Implantation Procedure 10
Hospital Electronics System Setup 10
Right Heart Catheterization and Sensor Implant Procedure 11
Patient Identification Card 12
Patient Counseling Information 12
Clinical Study Information 13
Introduction 13
Purpose 14
Methods 13
Patient Demographics and Disposition 14
Primary and Secondary Endpoint Results 15
Primary Safety Endpoints 15
Primary Efficacy Endpoint 16
Secondary Endpoints 16
Medical Management 17
Results from the Entire Randomized Access Period 17
HF Hospitalizations 17
Mortality 17
Freedom from Death or First HF Hospitalization 17
All Cause Hospitalizations 17
Death or All Cause Hospitalizations 18
Results from the Open Access Period (Longitudinal Analysis) 18
Treatment Effects in Women 18
Adverse Events 21
FCC Statement 31
Technical Support 31
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