Edwards SAPIEN 3 User Manual

20
The mean peak gradient decreased from 75.8 ± 22.6 mmHg at baseline to 21.2 ± 8.5 mmHg at 30 days,
as shown in Figure 7.
Figure 7:
Peak Gradient
(PIIS3HR VI Population)
The proportion of patients with AI ≥ moderate was 7.3% at baseline and 3.0% at 30 days, as shown in
Figure 8.
Figure 8:
Aortic Insufficiency
(PIIS3HR VI Population)
Peak Gradient (mmHg)
0
10
20
30
40
50
60
70
80
90
100
110
Baseline 30 Day
75.8
21.2
None Trace Mild
Mild-Moderate Moderate Moderate-Severe
Severe
Percentage
0
20
40
60
80
100
Baseline 30 Day
16%
30%
32%
32%
34%
27%
10%
8%
6%

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)