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

Close up of Edwards SAPIEN 3 valve bovine pericardial leaflet
Proven valve tissue

The same proven bovine pericardial leaflet as Edwards surgical valves, treated with the ThermaFix anticalcification process to reduce calcium deposit.

Close up of Edwards SAPIEN 3 valve profile
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
Close up of Edwards SAPIEN 3 valve frame
Frame design

Low cobalt-chromium frame height and open geometry facilitates future coronary access.2

Close up of Edwards SAPIEN 3 valve sealing skirt
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

Learn more
Close up of Edwards SAPIEN 3 COMMANDER delivery system

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.

Close up of Edwards SAPIEN 3 Aortic valve
Close up of Edwards SAPIEN 3 Aortic valve

Aortic | Transfemoral, Transapical, and Transaortic

Close up of Edwards SAPIEN 3 Mitral valve

Mitral | Transseptal, Transapical

3D sizing and delivery system

Edwards SAPIEN 3 valve is available in 4 sizes for maximum flexibility and optimal fitting.

Edwards SAPIEN 3 valve sizing chart

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 Trial

You refuse to compromise.

We couldn't agree more.

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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). Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

PP--EU-3362 v1.0