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SAPIEN 3
Edwards SAPIEN 3 Manuals
Manuals and User Guides for Edwards SAPIEN 3. We have
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Edwards SAPIEN 3 manual available for free PDF download: Instructions For Use Manual
Edwards SAPIEN 3 Instructions For Use Manual (47 pages)
Transcatheter Heart Valve with the Edwards Commander Delivery System
Brand:
Edwards
| Category:
Medical Equipment
| Size: 1 MB
Table of Contents
Device Description
2
Edwards Commander Delivery System
2
Indications
3
Contraindications
3
Warnings
3
Qualcrimp Crimping Accessory
3
Precautions
4
Potential Adverse Events
5
Directions for Use
7
Required Equipment
7
Additional Equipment
7
Valve Rinsing Procedure
7
Prepare the Components
8
Mount and Crimp the Valve on the Delivery System
9
Valvuloplasty and Valve Delivery
9
Baseline Parameters
10
Valvuloplasty
10
Valve Delivery
10
How Supplied
11
System Removal
11
Storage
11
MR Safety
11
Patient Information
12
Recovered Valve and Device Disposal
12
Clinical Studies
12
Patient Accountability
13
Patient Demographics and Baseline Characteristics
14
Safety and Effectiveness Results
14
Primary Endpoint
14
Primary Endpoint Analysis
15
Death and Stroke at 30 Days
15
Aortic Insufficiency by Visit
16
Aortic Insufficiency at 30 Days
16
Major Vascular Complications at 30 Days
17
Secondary Endpoints for Labeling
18
CEC Adjudicated Adverse Events at 30 Days
18
Valve Performance
19
Effective Orifice Area
19
Mean Gradient
19
Peak Gradient
20
Aortic Insufficiency
20
Aortic Paravalvular Leak
21
NYHA Class by Visit
21
Six Minute Walk Test (6MWT)
22
Length of Stay (Los)
22
Quality of Life (Qol)
22
Additional Qol Instruments
22
Summary of Supplemental Clinical Information
22
Accountability of the S3OUS Cohort
23
Study Population Demographics and Baseline Parameters
23
Patient Accountability (S3OUS)
23
CEC Adjudicated Adverse Events at 1 Year
24
All-Cause Mortality at 1 Year
26
Primary Endpoint Non-Inferiority Test
32
Patient Demographics and Baseline Characteristics of the EP Population
32
All-Cause Death and All Stroke at 1 Year
33
All-Cause Death through 1 Year (VI Population)
34
All Stroke through 1 Year
34
Aortic Insufficiency (AI) ≥ Moderate at 1 Year (VI Population)
35
Secondary Endpoints for Labeling – Gatekeeping/Hierarchical Method
35
Forest Plot – All-Cause Death at 30 Days (VI Population)
36
Forest Plot – All Stroke at 30 Days (VI Population)
36
CEC-Adjudicated Adverse Events through 1 Year
36
Bleeding Rate Using Site-Reported Units Transfused (EP Population)
37
Effective Orifice Area (VI Population)
38
Mean Gradient (VI Population)
38
Peak Gradient (VI Population)
39
Total Aortic Regurgitation (VI Population)
39
Aortic Paravalvular Leak (VI Population)
39
NYHA Class by Visit (EP Population)
41
NYHA Class by Visit – TF Versus Non-TF Access (EP Population)
41
Six-Minute Walk Test (6MWT)
41
6MWT Distance (EP Population)
41
Length of Stay (EP Population)
42
KCCQ Clinical Summary Score (EP Population)
42
KCCQ Clinical Summary Score - TF Versus Non-TF Access
43
EQ-5D Visual Analog Scale (EP Population)
44
SF-36 Health Status Questionnaire Score (EP Population)
44
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