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.
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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.
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.11
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. Data on file.
7. 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.
8. Data on file.
9. 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)
10. 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.
11. 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.
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, Commander, Edwards Commander, Edwards eSheath, COMMENCE, 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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