Evolut™ TAVR has a differentiated and intentional design.
Built on the original CoreValve™ platform, Evolut™ TAVR precisely conforms to the patient’s anatomy, maximizing space for optimal blood flow to consistently deliver large effective orifice areas (EOAs) and low gradients over time. The Evolut™ TAVR proprietary nitinol frame conforms to the annulus for consistent radial force across a wide treatable annulus range.
Supra-annular mounting
Facilitates circularity and maximizes leaflet coaptation for lower gradients and reduced workload on the ventricle.1
Higher outward canted commissures
Distributes mechanical forces to reduce leaflet stress, provide a larger effective orifice area, and minimize prosthesis-patient mismatch (PPM).1
External tissue wrap
Increases surface contact with native anatomy to reduce the risk of paravalvular leak (PVL).2
Four times larger windows
Intended to enable coronary access with the Evolut™ FX+ TAV.3
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Valve performance matters from day one.
Valve performance helps keep patients alive and out of the hospital.4
Durable valve performance, as defined by freedom from bioprosthetic valve dysfunction (BVD), is critical, regardless of the procedure or platform.
Four categories of bioprosthetic valve dysfunction†
Structural valve deterioration
Occurs years after AVR
Non-structural valve dysfunction
Occurs immediately after AVR
Thrombosis
Occurs unpredictably
any time after AVR
Endocarditis
Occurs unpredictably
any time after AVR
Poor valve performance results in worse outcomes.
BVD imparts
↑ 50%
relative increase in hazard
of death or rehospitalization at 5 years.4
Valve performance starts the day of the procedure and continues for a lifetime.
Early performance markers predict late outcomes.
0–30 days
Low gradient and large EOA
Freedom from:
Markers of BVD
- PVL
- PPM
30 days +
Freedom from:
- PVL
- Thrombosis
- Endocarditis
1 year +
Freedom from:
Structural valve deterioration (SVD)
5 years +
Freedom from:
- BVD/Bioprosthetic valve failure (BVF)
- Valve reinterventions
The Evolut™ TAVR design has a proven legacy of performance.
Years of research and rigorous trials have proven the Evolut™ design, establishing it as a clear leader in valve performance compared to both SAVR and other TAVR option.6,7
Superiority in the SMART Trial
Most recently in the SMART Trial, Evolut™ TAVR maintained superior valve performance‡ vs. SAPIEN™* TAVR in small annulus patients§ through 2 years.6
TAVR risks include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Significantly less BVD‡
with Evolut™ TAVR
vs. SAPIEN™* TAVR in small annulus patients§,6
Evolut™ TAVR: 12.5%
SAPIEN™* TAVR: 48.4%
p < 0.001
Demonstrating predictable, excellent outcomes
The use of standardized optimized care pathways and cusp overlap with the next generation Evolut™ FX TAV system is associated with low PPI rates and no moderate or severe AR at 30 days.7
6.7%
PPI (new onset/worsening CD)
at 30 days.
91%
of Evolut™ FX TAVR patients had none/trace AR and no moderate or greater AR at discharge.
Demonstrating predictable, excellent outcomes
The use of standardized optimized care pathways and cusp overlap with the next-generation Evolut™ FX TAV system is associated with low permanent pacemaker implantation (PPI) rates and no moderate or severe AR at 30 days.8
6.7%
PPI (new onset/worsening CD) at 30 days8
91%
of Evolut™ FX TAVR patients had none/trace AR and no moderate or greater AR at discharge.8
Outcomes that last.
Evolut™ TAVR shows durable clinical outcomes in low-risk patients at five years.9
All-cause mortality or disabling stroke at 5 years, 15.5% Evolut™ TAVR vs. SAVR 16.4%
Log-rank p-value at 5 years = 0.47
The Evolut™ platform evolves without compromising valve performance.
In partnership with physicians, the Evolut™ design has been meticulously refined and improved to solve unmet needs. Every decision is driven by the relentless pursuit of optimal and durable performance.
CoreValve™
TAV
2007◊
First self-expanding
TAVR valve
Evolut™ R
TAV
2014◊
Recapturability, lower profile, and more consistent radial force across annulus range
Evolut™ PRO
TAV
2017◊
PVL performance
Evolut™ PRO+
TAV
2019¶
Lower delivery profile and large valve PVL performance
Evolut™ FX
TAV
2022¶
Re-engineered delivery system for improved ease of use and radiopaque markers to reference for deployment depth and commissure location#
Evolut™ FX+
TAV
2024¶
The latest in a line of rapid innovations on the CoreValve™/Evolut™ platform offering access without compromise.2,10