Edwards SAPIEN 3 User Manual

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The proportion of patients with aortic paravalvular leak (PVL) ≥ moderate was 2.9% at 30 days, as shown
in Figure 9.
Figure 9:
Aortic Paravalvular Leak
(PIIS3HR VI Population)
NYHA
The NYHA class by visit is shown in Figure 10. For all patients, the mean NYHA class was 3.2 ± 0.6 at
baseline and 1.7 ± 0.7 at 30 days.
Figure 10:
NYHA Class by Visit
(PIIS3HR VI Population)
None
Trace Mild
Mild-Moderate Moderate Moderate-Severe
Severe
Percentage
0
20
40
60
80
100
30 Day
33%
29%
28%
8%
1 2
3 4
Percent
0
20
40
60
80
100
All Patients Transapical/Transaortic Transfemoral
Baseline 30 Day Baseline 30 Day
Baseline 30 Day
10%
60%
30%
45%
42%
11%
8%
64%
28%
36%
45%
14%
5%
10%
59%
31%
46%
42%
11%

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)