Edwards SAPIEN 3 Ultra RESILIA Valve

Preserves the clearest path
for future interventions

Edwards SAPIEN 3 Ultra RESILIA Valve

Preserves the clearest path
for future interventions

Making future options possible1,2

Excellent performance for today's coronary access

100%

(68/68) success post-TAVI coronary access rate1

Preserving coronary access for future needs

2%

risk of future sinus sequestration¶3

Risk of sinus sequestration if (1) prior TAV commissure level above STJ and (2) the distance between TAV and STJ was <2.0mm in each coronary sinus.

The Edwards SAPIEN platform brochure

When it comes to lifetime management, learn more about how the Edwards SAPIEN 3 platform is designed to deliver a TAVI experience an implanter can count on, starting with the index procedure.

View the brochure

Designed to host future valve interventions

Preserving future coronary access is a key consideration in valve-in-valve patients3,4

  • SAPIEN 3 valve-first TAVI reduces risks of future sinus sequestration†2
  • SAPIEN 3 valve-first TAVI facilitates favorable coronary access3

†Risk of sinus sequestration if (1) prior TAV commissure level above STJ and (2) the distance between TAV and STJ was <2.0mm in each coronary sinus.

The only platform approved and indicated for both TAV-in-TAV and TAV-in-SAV procedures5**

Primary endpoints of death and stroke for SAPIEN 3 valve (Native vs Redo)6

  • No statistical difference in death and stroke between redo SAPIEN 3 TAVI vs. native SAPIEN 3 TAVI at 1 year

** Patients assessed at high-risk for surgical replacement. Edwards Lifesciences SAPIEN 3/Ultra valve Instructions for Use.

Demonstrated clinical outcomes and sustained valve performance with SAPIEN 3 TAVI. Together, we aim for exceptional.

Outcomes

Consistent outcomes that matter, starting with the index procedure.7

Explore outcomes ›

Durability

A comprehensive approach to a durable therapy that offers proven long-term patient outcomes.7, 9

Explore durability ›

Clinical data on surgical valves with RESILIA tissue up to 7-year follow-up have been published, with additional follow-up to 10-years in progress.8

References:

1. Tarantini G, Fovino LN, Le Prince P, et al. Coronary access and percutaneous coronary intervention up to 3 years after transcatheter aortic valve implantation with a balloon-expandable valve. Circ Cardiovasc Interv. 2020;13(7):e008972.
2. Tarantini G, et al. Redo-Transcatheter aortic valve implantation using the SAPIEN 3/Ultra transcatheter heart valves – Expert Consensus on Procedural Planning Techniques, The American Journal of Cardiology, 2023
3. Ochiai T, Oakley L, Sekhon N, et al. Risk of coronary obstruction due to sinus sequestration in redo transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2020;13(22):2617-2627. doi:10.1016/j.jcin.2020.09.022.
4. De Backer O, Landes U, Fuchs A, et al. Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography. JACC Cardiovasc Interv. 2020;13(21):2528-2538.
5. Edwards Lifesciences SAPIEN 3/Ultra valve Instructions for Use.
6. Makkar RR, et al. Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study. Lancet. 2023 Aug 31:S0140-6736(23)01636-7.
7. Leon MB, Mack MJ, Pibarot P et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. 2025
8. Beaver T, Bavaria JE, Griffth B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2024;168(3):781-791. doi:10.1016/j.jtcvs.2023.09.047
9. Makkar R. Ten-year outcomes of the PARTNER 2 intermediate-risk studies: a propensity-matched analysis of P2S3i TAVR and P2A surgery. Presented at: TCT 2025; October 27, 2025; San Francisco, CA

Medical device 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).

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