Edwards SAPIEN 3 User Manual

Name: Edwards SAPIEN 3
Brand: Edwards
Rating: 5 (1 reviews)

46 pages

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Figure 26: Peak Gradient (VI Population)

Figure 27: Total Aortic Regurgitation (VI Population)

Figure 28: Aortic Paravalvular Leak (VI Population)

Device Description2
Edwards Commander Delivery System2
Indications3
Contraindications3
Warnings3
Qualcrimp Crimping Accessory3
Precautions4
Potential Adverse Events5
Directions for Use7
Required Equipment7
Additional Equipment7
Valve Rinsing Procedure7
Prepare the Components8
Mount and Crimp the Valve on the Delivery System9
Valvuloplasty and Valve Delivery9
Baseline Parameters10
Valvuloplasty10
Valve Delivery10
How Supplied11
System Removal11
Storage11
MR Safety11
Patient Information12
Recovered Valve and Device Disposal12
Clinical Studies12
Patient Accountability13
Patient Demographics and Baseline Characteristics14
Safety and Effectiveness Results14
Primary Endpoint14
Primary Endpoint Analysis15
Death and Stroke at 30 Days15
Aortic Insufficiency by Visit16
Aortic Insufficiency at 30 Days16
Major Vascular Complications at 30 Days17
Secondary Endpoints for Labeling18
CEC Adjudicated Adverse Events at 30 Days18
Valve Performance19
Effective Orifice Area19
Mean Gradient19
Peak Gradient20
Aortic Insufficiency20
Aortic Paravalvular Leak21
NYHA Class by Visit21
Six Minute Walk Test (6MWT)22
Length of Stay (Los)22
Quality of Life (Qol)22
Additional Qol Instruments22
Summary of Supplemental Clinical Information22
Accountability of the S3OUS Cohort23
Study Population Demographics and Baseline Parameters23
Patient Accountability (S3OUS)23
CEC Adjudicated Adverse Events at 1 Year24
All-Cause Mortality at 1 Year26
Primary Endpoint Non-Inferiority Test32
Patient Demographics and Baseline Characteristics of the EP Population32
All-Cause Death and All Stroke at 1 Year33
All-Cause Death through 1 Year (VI Population)34
All Stroke through 1 Year34
Aortic Insufficiency (AI) ≥ Moderate at 1 Year (VI Population)35
Secondary Endpoints for Labeling – Gatekeeping/Hierarchical Method35
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 Year36
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 Access43
EQ-5D Visual Analog Scale (EP Population)44
SF-36 Health Status Questionnaire Score (EP Population)44

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Edwards SAPIEN 3 Specifications

General

Product Name	Edwards SAPIEN 3
Category	Transcatheter Heart Valve
Valve Type	Balloon-expandable
Material	Bovine pericardial tissue
Frame Material	Cobalt-Chromium Alloy
Sizes	20 mm, 23 mm, 26 mm, 29 mm
Delivery System	Commander Delivery System
Regulatory Status	FDA Approved, CE Marked
Indication	Severe symptomatic aortic stenosis
Sheath Size	14F (20-23mm), 16F (26-29mm)