Uses same trusted bovine pericardium leaflet and ThermaFix anticalcification process as the Edwards SAPIEN 3 valve.
Edwards SAPIEN 3 Ultra valve
Built on proven technology
Advancing valve design
Built upon the proven SAPIEN platform, the SAPIEN 3 Ultra transcatheter heart valve is designed with your patient's future needs in mind.
Low profile and open cell geometry facilitate coronary access.1
Features a ~40% taller, textured polyethylene terephthalate (PET) outer skirt.*
*Compared to the Edwards SAPIEN 3 valve
Minimising paravalvular leak2
Important reductions in paravalvular leak (PVL)
Edwards SAPIEN 3 Ultra valve engineered to further reduce PVL
In the TVT Registry in over 1300 procedures:
- Edwards SAPIEN 3 Ultra valve eliminated severe PVL and produced close to zero levels of moderate PVL3
- Consistently low levels of mild PVL across the studies2-6
Moderate and severe PVL are independent predictors of 5-year all-cause mortality in multivariable analysis.7
Consistently low paravalvular leak rates at discharge3*
Single digit new permanent pacemaker rates
Low rates of new permanent pacemaker implantation (PPI) achieved with a high valve positioning strategy8
- New PPI is an independent predictor of mortality at 1 year9
Single digit new PPI rates at 30 days (including baseline)*
Today's transcatheter heart valve (THV) solution designed for lifetime patient management
Edwards SAPIEN 3 transcatheter aortic valve implantation (TAVI) is indicated for use in aortic and mitral redo procedures (including THV-in-THV)*
A lifesaving reintervention when TAVI is a preferred treatment option.
*For patients at high or greater surgical risk
Designed for future coronary access
Low profile frame design and open geometry facilitates future coronary access.1
Registry data from SOURCE 3 showed 100% successful coronary access (n=61) post-TAVI.10
The Edwards COMMANDER delivery system
Designed to streamline the TAVI procedure and reduce complications with an ultra-low delivery profile, optimal positioning control and predictable deployment.
For predictable, proven results
Features of the Edwards COMMANDER delivery system:
- Stable, precise deployment delivering 99% first-time accuracy11†
- Low delivery profile
- Dual articulation for coaxiality
- Optimal positioning control
†The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVI with the Edwards SAPIEN 3 valve, as-treated population (n=1078).11
3D Sizing and Delivery System Guide
Edwards SAPIEN 3 Ultra valve is available in 3 sizes for maximum flexibility and optimal fitting.
Edwards SAPIEN 3 valve is also available in a 29mm size for larger annular diameters.
Edwards Lifesciences SAPIEN 3 Ultra TAVI procedural videos
Procedural guides on transfemoral access and Edwards SAPIEN 3 Ultra TAVI procedures:
Prof Simon Redwood & Dr Bernard Prendergast testimonial on valve design and coronary access (01:52)
Coronary access live action procedural demonstration.
Transfemoral approach for TAVI using balloon-expandable technology (02:19)
Transfemoral access procedure from insertion to deployment.
Edwards SAPIEN 3 Ultra valve — built for coronary access (01:06)
Edwards SAPIEN 3 Ultra valve coronary access and deployment procedure in detail.
Contact your Edwards Lifesciences Sales Representative for more information.
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1. Yudi MB, et al. Coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement. J Am Coll Cardiol. 2018;71(12):1360-1378.
2. Webb, J. A prospective multicenter study of the SAPIEN 3 Ultra system in intermediate-risk patients with severe aortic stenosis. Presented at PCR London Valves 2019 (Nov 2019).
3. Nazif et al. Real-World Experience with the SAPIEN 3 Ultra TAVR: A Propensity Matched Analysis from the United States, TVT Connect 2020.
4. Rheude. Transcatheter Aortic Valve Replacement With Balloon-Expandable Valves Comparison of SAPIEN 3 Ultra Versus SAPIEN 3. JACC: Cardiovasc Interv. 2020;13(22)2631-2638.
5. Moriyama N. et al. Hemodynamic comparison of TAVR with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry. Catheter Cardiovasc Interv. 2021;97(7):E982-E991.
6. Saia F et al. SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: in-hospital and 30-day results from the multicentre S3U registry. EuroIntervention. 2020;15(14):1240-1247.
7. Giuliano Costa MD et al., Long-term outcomes of self-expanding versus balloon-expandable transcatheter aortic valves: Insights from the OBSERVANT study. Valvular and Structural Heart Diseases. First published: 13 April 2021. https://doi.org/10.1002/ccd.29701
8. Sammour Y. et al. Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation. Circulation: Cardiovascular Interventions 2021, 14:e009407.
9. Glaser N, et al., JAMA Network Open. 2021;4(7):e2116564. doi:10.1001/jamanetworkopen.2021.16564.
10. Tarantini G, Fovino LN, Le Prince P, 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;13(7):e008972.
11. Thourani VH et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 2016; 387: 2218–2225.
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).