Plan your next move right from the start

Making future options possible

Plan your next move right from the start

Making future options possible

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.

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.8

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Future Interventions

Making future options possible.1,2

Explore future options ›

No clinical data are available to evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.

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. 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. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023.

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, and SAPIEN 3 Ultra 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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