St. Jude Medical CardioMEMS CM1010 Manuals

Manuals and User Guides for St. Jude Medical CardioMEMS CM1010. We have 1 St. Jude Medical CardioMEMS CM1010 manual available for free PDF download: User Manual

St. Jude Medical CardioMEMS CM1010 User Manual

St. Jude Medical CardioMEMS CM1010 User Manual (32 pages)

HF System, PA Sensor and Delivery System

Brand: St. Jude Medical | Category: Medical Equipment | Size: 0 MB

Table of Contents

Table of Contents
3
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
  13
- 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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