Edwards SAPIEN 3 User Manual

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Figure 29: NYHA Class by Visit (EP Population)
Figure 30: NYHA Class by Visit – TF versus non-TF Access (EP Population)
Six-Minute Walk Test (6MWT)
The improvements in mean 6MWT distance are presented in Table 24. As compared to the
SAPIEN 3 patients, the PIIA-SAVR patients had a decrease in mean 6MWT distance from
baseline to 30 days.
Table 24: 6MWT Distance (EP Population)
6MWT
Distance (m)
SAPIEN 3 Valve
PIIA-SAVR
All
TF
Non-TF

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)