Edwards SAPIEN 3 transcatheter aortic valve implantation (TAVI) — approved for all severe aortic stenosis (sAS) patients irrespective of surgical risk

A proven story of continuous innovation and patient-centricity.

The first-in-human Edwards-Cribier valve was implanted by Prof. Alain Cribier in 2002 showing the feasibility of TAVI concept.1

As Edwards received the CE Mark for SAPIEN valve in 2007,2 the company has set the stage to continue innovating in TAVI, bringing new technologies with improved clinical outcomes.3-6

Close up of Edwards SAPIEN transcather heart valve
2007
Edwards SAPIEN valve

The first-generation Edwards SAPIEN valve was introduced as a lifesaving treatment option for inoperable and high surgical risk patients.3,4

Close up of Edwards Lifesciences SAPIEN XT valve
2010
Edwards SAPIEN XT valve

Demonstrated the value of TAVI for intermediate-risk patients, proving non-inferior to surgery on mortality and stroke.5

Edwards SAPIEN 3 valve
2014
Edwards SAPIEN 3 valve

Proved superior to surgery in low-risk patients in the landmark PARTNER 3 Trial.6

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

TAVI valve approved for aortic and mitral valve-in-valve procedures.

Close up of Edwards SAPIEN 3 Ultra transcatheter heart valve
2018
Edwards SAPIEN 3 Ultra valve

Continues to elevate Edwards’ TAVI valve performance, with further reductions in paravalvular leak (PVL)7 and low permanent pacemaker implantation rates,8 through improved design features.

Edwards SAPIEN 3 and SAPIEN 3 Ultra valve — achieving your higher standard

The benefits of shared technology9

Edwards SAPIEN 3 Ultra valve is the latest TAVI valve in the Edwards Lifesciences portfolio, designed with a taller textured PET outer skirt while still sharing all of the benefits of its predecessor Edwards SAPIEN 3 valve:

  • The same high-radial strength cobalt-chromium frame and inner skirt
  • The same bovine pericardium tissue
  • A complete range of valve sizes: 20mm; 23mm; 26mm; 29mm (only in Edwards SAPIEN 3 valve)
  • Edwards COMMANDER delivery system for predictable deployment and sealing

Edwards SAPIEN design principles

Since Edwards was founded in 1958, our focus has always been on improving the quality of life of every patient that all our valves treat.

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Find out more about Edwards SAPIEN 3 and SAPIEN 3 Ultra valve

Edwards SAPIEN 3 Ultra valve

Close up of Edwards SAPIEN 3 Ultra transcatheter heart valve More about Edwards SAPIEN 3 Ultra valve

Edwards SAPIEN 3 valve

Close up of Edwards SAPIEN 3 transcatheter heart valve More about Edwards SAPIEN 3 valve

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References:

1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis. Circulation. 2002;106:3006-3008.
2. Weigerinck EMA, Van Kesteren F, Mourik MS, et al. An up-to-date overview of the most recent transcatheter implantable aortic valve prostheses. Expert Rev Med Devices 2016;13(1):31-45.
3. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.
4. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. N Engl J Med. 2011;364:2187-2198.
5. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609-1620.
6. Mack M, Leon M, Thourani R, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695-1705.
7. Nazif T, Daniels D, McCabe J, Chehab B, et al. Real-world experience with the SAPIEN 3 Ultra TRANSCATHETER AORTIC VALVE IMPLANTATION : A propensity matched analysis from the United States. Presented virtually at TVT Connect 2020.
8. Saia F, et al. In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable TAVR: the S3U registry. Eurointervention 2020;15(14):1240-1247.
9. Data on file at Edwards Lifesciences.

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 devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

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