Your TAVI Strategy Starts Here

Bringing you the latest updates on Edwards SAPIEN 3 Platform

Your TAVI Strategy Starts Here

Bringing you the latest updates on Edwards SAPIEN 3 Platform

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.

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

*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.
†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.

Built for now and what's next

Edwards SAPIEN platform: The move for lifetime management

Your first valve choice matters. Your strategy for lifetime management starts with the Edwards SAPIEN 3 platform, designed to deliver a reliable TAVI experience so patients can live their best lives.3,4,5

Explore Edwards SAPIEN 3 platform for lifetime management

The PARTNER 3 trial 5 year data

Data from the PARTNER 3 trial continues to prove the Edwards SAPIEN 3 platform is the choice for lifetime management – from the index procedure and beyond.

  • Life: The only transcatheter heart valve with 1% death or disabling stroke at 1 year1
  • Time: The only transcatheter heart valve with 90% survival at 5 years6
  • Management: The only transcatheter heart valve with a THV-in-THV indication5*
Visit NEJM to download

*For patients assessed at high-risk for surgical replacement.

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

Explore Edwards Innovation
Female interventional cardiologist holding a microphone presenting to a room full of doctors

Resources

Resources for download

Useful for you and your patients, including heart anatomy guide, clinical summary PDFs and more.

Access resources

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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.

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.

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).