Built for now and what’s next

A comprehensive approach to durability

A comprehensive approach to a durable therapy that offers proven long-term patient outcomes¹

^‡Compared to SAPIEN 3 transcatheter heart valve.

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.

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The Edwards SAPIEN 3 platform has demonstrated excellent durability

The PARTNER II S3i trial has demonstrated:

Transcatheter aortic valve replacement (TAVI) durability similar to surgery at five years^1†
Low rates of structural valve deterioration (SVD) and SVD-related bioprosthetic valve failure, similar to surgery at five years^1†

Real-world data has demonstrated:

Excellent five-year SAPIEN valve durability performance for small-annuli patients²

^† Propensity-matched analysis of intermediate-risk patients using VARC 3 definitions of structural valve deterioration (SVD) and SVD-related bioprosthetic valve failure at 5 years.

Outcomes

Consistent outcomes that matter, starting with the index procedure.³

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Durability

A comprehensive approach to a durable therapy that offers proven long-term patient outcomes.¹

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Future Interventions

Making future options possible.^4,5

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References:

1. Pibarot P, Ternacle J, Jaber WA, et al. Structural deterioration of transcatheter versus surgical aortic valve bioprosthesis in PARTNER-2 trial. J Am Coll Cardiol. 2020;76:1830-1843.
2. Okuno T, Tomii D, Lanz J, et al. 5-year outcomes with self-expanding vs balloon-expandable transcatheter aortic valve replacement in patients with small annuli. JACC Cardiovasc Interv. 2023;16(4):429-440. doi:10.1016/j.jcin.2022.11.032.
3. 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.
4. Pibarot P, Ternacle J, Jaber WA, et al. Structural deterioration of transcatheter versus surgical aortic valve bioprosthesis in PARTNER-2 trial. J Am Coll Cardiol. 2020;76:1830-1843.
5. 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
6. Edwards Lifesciences data on file.
7. Tamm AR, et al. Minimizing Paravalvular Regurgitation With the Novel SAPIEN 3 Ultra TAVR Prosthesis: A Real-World Comparison Study. Front. Cardiovasc. Med. 8:623146, 2021.
8. Nazif TM, Cahill TJ, Daniels D, et al. Real-world experience with the SAPIEN 3 Ultra transcatheter heart valve: a propensity-matched analysis from the United States. Circ Interventions. 2021; 14:e010543.

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, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, PARTNER, and PARTNER II, 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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