Edwards SAPIEN 3 User Manual

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NYHA
The NYHA classifications by visit are presented in Figure 29. In PIIS3i, 72.6% of the patients
were in NYHA Class III or IV at baseline, which reduced to 6.3% at 30 days and 6.7% at 1 year,
while in PIIA-SAVR, the percentage of patients in NYHA Class III or IV was 76.0% at baseline,
13.6% at 30 days, and 6.7% at 1 year. A side-by-side comparison of the results by access
approach is presented in Figure 30.

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)