Edwards SAPIEN 3 TAVI

Aim For Exceptional

Edwards SAPIEN 3 TAVI

Aim For Exceptional

As a leader in heart valves for over 60 years, Edwards Lifesciences is dedicated to providing you a destination for the latest transcatheter heart valve information, tools, resources, and innovative solutions.

Introducing the Edwards SAPIEN 3 Ultra RESILIA valve

Building on the benefits of the SAPIEN 3 platform3,4,5, the SAPIEN 3 Ultra RESILIA valve features RESILIA tissue, an advanced calcium-blocking technology.1,2 The SAPIEN 3 Ultra RESILIA valve takes TAVI even further with the potential to improve valve longevity and reduce reintervention.1

Learn about 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.16
†RESILIA tissue tested against tissue from commercially available bovine pericardial valves from Edwards Lifesciences in a juvenile sheep model. Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149 (1):340-345.

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Edwards SAPIEN 3 TAVI: changing lives starts with outcomes

SAPIEN 3 TAVI is an excellent choice for patients with severe aortic stenosis, regardless of symptoms.12-15

Explore Edwards SAPIEN 3 TAVI
Durable outcomes through 5 years icon

In the randomized, controlled PARTNER 3 Trial studying TAVI vs SAVR, SAPIEN 3 TAVI demonstrated out to 7 years12:

  • Sustained durability and performance
    • Low rates of bioprosthetic valve failure (BVF)*
      (6.9% TAVI, 7.3% SAVR; p = 0.78)
    • Low rates of aortic-valve reintervention
      (6.7% TAVI, 6.0% SAVR; p = 0.72)
  • Comparable to SAVR in other key outcomes, including all-cause mortality,† cardiovascular mortality, and quality of life

*BVF per VARC-3 consists of the following components: (1) irreversible stage 3 hemodynamic valve deterioration, (2) aortic-valve reintervention, (3) valve-related death.
†A vital status (alive or dead) sweep was conducted to improve the completeness of follow-up.

See the "Seven-year Outcomes of the PARTNER 3 Low-risk Trial"

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Edwards SAPIEN 3 platform

Edwards SAPIEN 3 Ultra RESILIA valve

Edwards SAPIEN 3 Ultra RESILIA valve

The latest innovation in the TAVI portfolio featuring RESILIA tissue, an advanced calcium-blocking technology.2

Edwards SAPIEN 3 Ultra RESILIA valve
Edwards SAPIEN 3 Ultra valve

Edwards SAPIEN 3 Ultra valve

Addition of novel skirt technology reduces moderate, severe and mild paravalvular leak (PVL).10

Edwards SAPIEN 3 Ultra valve
Edwards SAPIEN 3 valve

Edwards SAPIEN 3 valve

The first TAVI valve to receive CE mark for severe aortic stenosis (sAS) patients at low surgical risk.11

Edwards SAPIEN 3 valve
Edwards SAPIEN XT valve

Edwards SAPIEN XT valve

Proved non-inferior to surgery for mortality and stroke in the PARTNER IIA Trial.6

Technology and Innovation
Edwards SAPIEN valve

Edwards SAPIEN valve

Introduced as a lifesaving treatment option for inoperable and high surgical risk patients.7,8

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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 progress16

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. et al. Transcatheter aortic valve replacement in low-risk patients at five years. NEJM. 2023; 389:1949-1960.
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 Jul;13(7):e008972.
5. Madhavan MV, et al. Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2023;82(2):109-123.
6. Leon MB, et al. N Engl J Med 2016;374:1609-1620 and supplementary material.
7. Leon MB, Smith CR, Mack M, et al; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607.
8. Smith CR, Leon MB, Mack MJ, et al.; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187-98.
9. Galper BZ, et al. Economic Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Low Surgical Risk: Results from the PARTNER 3 Trial. Circulation. 2023 May 23;147(21):1594-1605.
10. Nazif T, Daniels D, McCabe J, et al. Real-world experience with the SAPIEN 3 Ultra TAVI: A propensity matched analysis from the United States. Presented at TVT Connect 2020; June 18-28, 2020.
11. 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.
12. 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.
13. 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; San Francisco, CA; October 25-28, 2025
14. Généreux P et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Eng J Med. 2025;392:217–227
15. SAPIEN Platform IFU
16. 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).

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