Design that delivers
Evolut™ built for a lifetime of care
Evolut™ design differentiation is at the root of the valve performance and durability that has been proven in randomized clinical trials.1,2
Explore Evolut™ durability clinical data
No other TAVI platform has shown better valve performance over SAVR in multicenter, randomized clinical trials.1
CoreValve™/Evolut™ TAVI is the first and only platform to demonstrate significantly better valve performance versus SAVR at 5 years.‡1
Bioprosthetic valve dysfunction out to 5 years†1
† BVD was defined as follows:
1) stage ≥2 hemodynamic SVD, characterized as an increase in mean gradient of ≥10 mm Hg from 30 days/discharge to last available echocardiogram with a final mean gradient of ≥20 mm Hg, or new occurrence or increase of 1 grade or more of intraprosthetic AR resulting in moderate or severe regurgitation;
2) NSVD, severe PPM at 30 days/discharge or severe PVR through 5 years per Valve Academic Research Consortium (VARC-3) criteria;
3) clinical valve thrombosis associated with clinical sequelae and hemodynamic impairment (CEC-adjudicated);
4) infectious endocarditis of the native valve or bioprosthesis following the Duke Classification system according to VARC-3 criteria
‡ In pooled analysis of intermediate- and high-risk patients.
1 Yakubov SJ, Van Mieghem NM, Oh JK, et al. Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at ≥ Intermediate Risk. J Am Coll Cardiol. 2025;85(13):1419-1430. doi:10.1016/j.jacc.2025.02.009
No other TAVI platform has ever shown a sustained durability benefit over SAVR in a multicenter, randomized clinical trial out to 10 years.†1
Statistically lower rates of severe structural valve deterioration (SVD) out to 10 years versus surgery†1
NOTION Trial: SVD out to 10 years
† In patients at lower surgical risk over the age of 70.
1 Thyregod HGH, Jørgensen TH, Ihlemann N, et al. Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial. Eur Heart J. 2024;45(13):1116-1124. doi:10.1093/eurheartj/ehae043
The data from this real-world registry shows that SVD† (structural valve deterioration) is a predictor of heart failure rehospitalization and cardiovascular mortality.
The risk of SVD was also significantly lower in the SE (self-expanding) valve arm (89,7% CoreValve™ Evolut™ valves).1
Multicentric Real World International TAVI Registry (n=2040)
IPTW- Matched Cohorts (n=1848)
BE-valves
(n=973)
VS
SE-valves
(n=875)
Impact of SVD in clinical outcomes
SVD was associated with increased risk of heart failure rehospitalization and a trend towards a higher risk of cardiovascular death.
Incidence of SVD according to VARC-3 criteria
The risk of SVD was higher among BE-valve compared to SE-valve recipients in the matched cohorts.
† SVD refers to haemodynamic valve deterioration (HVD) Stage ≥2 according to VARC-3
1 Iria Silva, et al., ‘Incidence and impact of structural valve deterioration following TAVI: a multicenter real-world study’, European Heart Journal - Cardiovascular Imaging, Volume 26, Issue 6, June 2025, Pages 1018–1028
A recent study in young and low-risk patients demonstrates that PPM† (Prosthesis-Patient Mismatch) is independently associated with outcomes at 5-years.1
Age <75 years,
STS score <4 %
(N = 512)
Significant predictors
- Younger age
- Female
- Larger BSA
- No balloon postdilation
- Smaller annulus area
Incidence of PPM in balloon-expandable valves* is independent of valve size
* Single-center, retrospective, observational study , devices used : SAPIEN™3, SAPIEN™3 Ultra, or SAPIEN™3 Ultra RESILIA™, Edwards Lifesciences† PPM was defined according to VARC-3 criteria
1 Suruga K, et Al., Prosthesis-Patient Mismatch in Young and Low-Risk Patients After Newer Generation Balloon-Expandable Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2025;18(12):1512–1523.
Numerically lower rate of cardiovascular mortality1
7.2% Evolut™ TAVI vs. 9.3% SAVR;
p = 0.15
5-year all-cause mortality or disabling stroke in Evolut™ Low Risk Trial1
1 JK, Yakubov SJ, Deeb GM, et al. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2025;85(15):1523-1532. doi:10.1016/j.jacc.2025.03.004
Keep exploring the Evolut™ TAVI platform!
Medtronic’s latest innovation and CE marked indication offer a spectrum of options for patient lifetime management, such as coronary access and redo-TAV.
1. Herrmann H. Two-Year Outcomes of the Five-Year SMART Trial; presented at CRT 2025.
2. Forrest JK, et al. J Am Coll Cardiol. 2025:S0735-1097(25)05335-5