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
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.