Built on the legacy of the SAPIEN 3 Ultra valve and the INSPIRIS RESILIA valve
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.9
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*Compared to SAPIEN 3 valve
PVL = Paravalvular Leak
When it comes to lifetime management, learn more about how the Edwards SAPIEN 3 Ultra RESILIA platform is designed to deliver a TAVI experience an implanter can count on, starting with the index procedure.
Predictability and control to meet the increasing complexity of
*16F & 6.0 mm for 29 mm SAPIEN 3 Ultra RESILIA valve.
*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.9
RESILIA tissue surgical valves had significantly improved freedom from reoperation due to SVD* compared to Non-RESILIA valves
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*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.
THV, transcatheter heart valve; SAV, surgical aortic valve; SAVR, surgical aortic valve replacement.
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.9
References:
1. Data on file.
2. Kini AS et al. 1-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the US. JACC Cardiovasc Interv. 2025 Mar 24;18(6):785-797.
3. SAPIEN 3 Ultra RESILIA IFU
4. Mack MJ et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705
5. SAPIEN 3 Ultra RESILIA eSHeath + IFU
6. De La Fuente AB et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
7. Kaneko, T, Johnston D, Bavaria JE, et al. Propensity-matched 8-year Outcomes Following Surgical Aortic Valve Replacement with ith Novel Calcification-resistant Versus Contemporary Tissue Bioprostheses. Presented at the Heart Valve Society Annual Scientific Meeting, April 2025. Standardized definition of SVD was utilized (Akins et. al 2008)
8. Tarantini G et al. Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study. Circ Cardiovasc Interv. 2022 Feb;15(2):e011045.
9. 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.
10. 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
11. 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
12. Tarantini G, Nai Fovino L, Le Prince P, et al. Coronary access and percutaneouscoronary intervention up to 3 years after transcatheter aortic valve implantation with a balloon expandable valve. Circ Cardiovasc Interv. 2020;13(7):e008972.
13. 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
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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