Proven valve tissue
The same proven bovine pericardial leaflet as Edwards surgical valves, treated with the ThermaFix anticalcification process to reduce calcium deposit.
Edwards SAPIEN 3 valve
Setting higher standards for today’s TAVI
The defining features of the Edwards SAPIEN 3 valve
Edwards SAPIEN 3 valve is the only transcatheter aortic valve implantation (TAVI) system superior to surgical aortic valve replacement (SAVR) for combined death, stroke and rehospitalisation in aortic stenosis (AS) patients of low-surgical risk.1
Low profile access
Low profile access helps to reduce major vascular complications.
- 2.2% at 30 days post procedure observed across 496 patients in the PARTNER 3 Trial1
Frame design
Low cobalt-chromium frame height and open geometry facilitates future coronary access.2
Outer sealing skirt
The outer sealing skirt virtually eliminates moderate or greater paravalvular leak
- Only 4 of 487 patients assessed at 30 days post TAVI in the PARTNER 3 Trial
Transfemoral delivery system
Edwards SAPIEN 3 valve shares the same optimised, ergonomically designed Edwards COMMANDER and eSheath delivery systems as Edwards SAPIEN 3 Ultra valve.
The Edwards COMMANDER delivery system
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Aortic and Mitral valve-in-valve procedures
Edwards SAPIEN 3 valve is approved for valve-in-valve procedures in both the aortic and mitral positions, allowing patients at high or greater surgical risk to avoid an additional open-heart procedure.
Aortic | Transfemoral, Transapical, and Transaortic
Mitral | Transseptal, Transapical
3D sizing and delivery system
Edwards SAPIEN 3 valve is available in 4 sizes for maximum flexibility and optimal fitting.
Proven superior to surgery in PARTNER 3 Trial
Edwards SAPIEN 3 TAVI: proven superiority to surgery in low-risk patients1
In the combined end-point of all-cause mortality, stroke, or rehospitalisation at 1 year post-procedure (8.5% for TAVI vs 15.1% for surgery, p=0.001).
Rehospitalisation rates at 1 year.
1% death or disabling stroke at 1 year, approximately 3 times lower than surgery.
PARTNER 3 Trial results enabled Edwards SAPIEN 3 valve to be the first TAVI valve to achieve CE labelling for low-risk severe aortic stenosis (sAS) patients
Edwards SAPIEN 3 valve in PARTNER 3 TrialStay informed with our newsletter
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References:
1. Mack M, Leon M, Thourani R, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695-1705 (plus Supplementary Appendix).
2. Nazif et al. Real-World Experience with the SAPIEN 3 Ultra TAVR: A Propensity Matched Analysis from the United States, TVT Connect 2020.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
PP--EU-3362 v1.0