A comprehensive approach to durability

A comprehensive approach to durability

2025 ESC/EACTS Guidelines Lower TAVI Age to 701 : Confidence Built on Proven Valve Durability

Proven early benefits with sustained, long-term outcomes comparable to SAVR 2,3

SAPIEN 3 Platform: Proven Long‑Term Durability

Get the latest PARTNER trial evidence. Discover how the SAPIEN 3 valve platform delivers excellent durability and sustained clinical performance at 7 years in low-risk patients and 10 years in intermediate risk patients — helping Heart Teams make confident decisions.2,3

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SAPIEN 3 Valve Outcomes Similar to Surgery at 10-Years* in Intermediate Risk Patients2

SAPIEN 3 Valve Demonstrated Excellent Durability Comparable to SAVR out to 7 Years3

Re-stenosis and PVL: Main Drivers of reintervention in PARTNER 3 trial3

The SAPIEN 3 Ultra RESILIA valve

Advanced calcium-blocking tissue technology5,6

Potential to improve valve longevity and reduce risk of reintervention*

Taller, textured outer skirt extended to 29mm valve5

Delivering the PVL results you demand impacting immediate and long-term outcomes11,12

Only THV with dry tissue storage5,6

Mitigates calcium-attracting glutaraldehyde residuals6

Explore clinical data for RESILIA tissue

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in TAVI patients.

Outcomes

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

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Durability

A comprehensive approach to a durable therapy that offers proven long-term patient outcomes.3

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Future Interventions

Making future options possible.8,9

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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.10

References:

1. Praz F, et al. 2025 ESC / EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Aug 29:ehaf194
2. Makkar R, et al on behalf of The PARTNER 2 Trial Investigators. Ten-year outcomes of the PARTNER 2 intermediate risk studies: a propensity matched analysis of P2S3i and P2A surgery., TCT presentation 2025
3. Leon MB, Mack MJ, et al. Transcatheter or surgical aortic valve replacement in low-risk patients at seven years. N Engl J Med. 2025.
4. Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021;42(19):1825-1857.
5. Data on file
6. De la Fuente et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. Journal of Heart Valve Disease. 2015
7. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695-1705
8. Tarantini G 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
9. 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
10. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2024 Sep;168(3):781-791.
11. Kodali S et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards SAPIEN valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J. 2015
12. Makkar R et al. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2020

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).

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, PARTNER, PARTNER II, PARTNER 3, and the PARTNER design logo are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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