A proven story of continuous innovation and
The first-in-human Cribier-Edwards 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
Edwards SAPIEN 3 Ultra RESILIA valve
Introduced RESILIA tissue.
The latest innovation in the TAVI portfolio featuring RESILIA tissue, an advanced calcium blocking technology.10
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.
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 Ultra valve
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.9
TAVI valve approved for aortic and mitral valve-in-valve procedures.9
Edwards SAPIEN XT* valve
Demonstrated the value of TAVI for intermediate-risk patients, proving non-inferior to surgery on mortality and stroke.5
*SAPIEN is an older model that has been discontinued and it is not available for commercial use.
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
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:
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.
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.
Explore Edwards SAPIEN 3 platform for lifetime managementThank you for signing up to the heartvalves.com newsletter. You will now receive emails on the latest developments and industry insights on heart valve innovation and technology.
THV = Transcatheter Heart Valves
TAVI = Transcatheter Aortic Valve Implant
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.
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 TM, et al. Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States. Circ Cardiovasc Interv. 2021 Sep;14(9):e010543.
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.
10. De la Fuente AB, Wright GA, Olin JM, et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. Jrnl of Heart Valve Disease. 2015.
11. 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.
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, Cribier-Edwards, Edwards SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, PARTNER, PARTNER 3, RESILIA, SAPIEN, SAPIEN XT, SAPIEN 3, and SAPIEN 3 Ultra are trademarks or service marks of Edwards Lifesciences or its affiliates. All other trademarks are the property of their respective owners.
PP--EU-6957 v2.0
