A comprehensive approach to a durable therapy that offers proven long-term patient outcomes3

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.

Demonstrated durability with ultra-low rates of reintervention9

Durability proven similar to SAVR after 5 years
All-cause BVF chart
SVD-related BVF chart
Partner 3 Trial Logo

The SAPIEN 3 Ultra RESILIA valve

Advanced calcium-blocking tissue technology1,2

Potential to improve valve longevity and reduce risk of reintervention

Taller*, textured outer skirt extended to 29mm valve1

Delivering the PVL results you demand impacting immediate and long-term outcomes3,4

Only THV with dry tissue storage1

Mitigates calcium-attracting glutaraldehyde residuals

Explore clinical data for RESILIA tissue

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
RESILIA tissue tested against tissue from commercially available bovine pericardial valves from Edwards in a juvenile sheep model. Flameng, et al. J Thorac Cardiovasc Surg 2015;149:340-5.

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. Data on file.
2. De la Fuente et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. Journal of Heart Valve Disease. 2015.
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. 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.
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.
9. 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, 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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