Edwards SAPIEN 3 User Manual

19
Valve Performance
The mean EOA increased from 0.7 ± 0.2 cm
2
at baseline to 1.6 ± 0.4 cm
2
at 30 days, as shown in
Figure 5.
Figure 5:
Effective Orifice Area
(PIIS3HR VI Population)
The average mean gradient decreased from 45.5 ± 14.3 mmHg at baseline to 11.1 ± 4.5 mmHg at 30
days, as shown in Figure 6.
Figure 6:
Mean Gradient
(PIIS3HR VI Population)
Doppler Velocity Index
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
1.6
1.8
2.0
Baseline 30 Day
0.7
1.6
Mean Gradient (mmHg)
0
10
20
30
40
50
60
70
80
90
100
110
Baseline 30 Day
45.5
11.1

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)