Clinical Evidence Transcatheter Aortic Valve Replacement

 

Evolut™ Platform Valve Performance


Evolut PRO US Study

Evolut PRO Paravalvular Regurgitation


Advanced Sealing


Advanced Sealing

Evolut PRO Valve Performance

Unsurpassed hemodynamics with large mean effective orifice area and low single-digit gradients.

Evolut PRO Valve Performance


Evolut R US Study

pdf One-Year Results from the Evolut R US Pivotal Study (.pdf)

View the data presented at the 2016 TCT Annual Meeting.

1.7MB

Unsurpassed valve hemodynamics with large stable effective orifice areas and low single-digit gradients.

EOA MeanGradient EvolutR

Evolut R Paravalvular Regurgitation

High rates of none or trace paravalvular regurgitation out to 12 months.

PVL EvolutR

Evolut R — All Cause Mortality and Disabling Stroke

Proven platform with low rates of mortality and disabling stroke.

1 Year Stroke ACM 30 Day

Evolut R Additional Safety Outcomes

Low rates of major vascular complications, life threatening or disabling bleeding, pacemaker rate.

30 Day MVC PPM Bleeding EvolutR

FORWARD Study

pdf Evolut R Forward 30-Day Outcomes  (.pdf)

View the data presented at the 2016 TCT Annual Meeting.

839KB

30-Day All Cause Mortality

Low 2.0% rate of all-cause mortality at one month.

30-day Mortality Chart

Additional Safety Outcomes

Low rate of VARC-II safety events at one month.

VARC II Safety FORWARD

New Pacemaker Rate

Low rate of new permanent pacemaker.

chart

Hemodynamic Outcomes

Valve Performance

Unsurpassed hemodynamics with large mean effective orifice area and low single-digit gradients.

Valve Performance FORWARD

Paravalvular Regurgitation

High rates of none or trace paravalvular regurgitation.

Paravalvular Leak FORWARD