LOTUS Edge™

Valve System

Watch the Principal Investigators Talk about the REPRISE III Data Highlights

CAUTION: The LOTUS™ Valve System/LOTUS Edge™ Valve System may only be used in countries where it is approved for use. LOTUS Edge is not available for sale in the European Economic Area. For informational purposes only.

REPRISE III Data Highlights

 

 

REPRISE III Key Results

LOTUS™ & Evolut R / CoreValve® 
N=607      N=305
REPRISE III Key Results LOTUS & Evolut R / CoreValve
Intent-to-Treat
*Composite of all-cause death, stroke, life-threatening/major vascular complications & stage 2/3 AKI (Implanted)
†Composite of all-cause death, disabling stroke & moderate or greater paravalvular leak (PVL, core lab assessment)
Presented by T. Feldman, MD at EuroPCR 2017

 

 

LOTUS Valve Superior to Evolut R / CoreValve In Primary Efficacy Endpoint **

LOTUS Valve = 15.8%  v. Evolut R / CoreValve Platform = 26.0%  
Superiority P < 0.001
 

†CoreValve platform is approximately ½ CoreValve and ½ Evolut R.
**Composite of moderate/severe PVL, disabling stroke, and all death. N = 912 
*Component of Primary Effectiveness Endpoint.
^Neurologic exam conducted by a neurology professional was required at baseline, discharge, 1 year, and after any suspected stroke. NIHSS was required at discharge and 1 year and mRS at baseline and all f/u time points. Event rates for Primary Effectiveness endpoint  (superiority based on Intent to Treat).

Presented by T. Feldman, MD at EuroPCR 2017 

 

 

Superior PVL Performance with Significantly Lower PVL

Presented by T. Feldman, MD at EuroPCR 2017

 

 

Superior Stroke Outcomes with a Significantly Lower Disabling Stroke Rate

Superior Stroke Outcomes with a Significantly Lower Disabling Stroke Rate

ITT; KM Event Rate ± 1.5 SE; log-rank P value

Presented by T. Feldman, MD at EuroPCR 2017

 

 

Superior procedural outcomes with 0% malpositioning and 0% TAV in TAV procedures. The LOTUS Valve is designed to allow full valve assessment before release and to be repositionable after 100% valve deployment. 
Presented by T. Feldman, MD at EuroPCR 2017

 

 

LOTUS Valve Platform Non-Inferior to Evolut R / CoreValve Platform

LOTUS Valve = 20.3%  v. Evolut R / CoreValve Platform = 17.2% 

Non-inferiority P = 0.003
 

†CoreValve platform is approximately ½ CoreValve and ½ Evolut R. 
^Neurologic exam conducted by a neurology professional was required at baseline, discharge, 1 year, and after any suspected stroke. NIHSS was required at discharge and 1 year and mRS at baseline and all f/u time points. Event rates for Primary.
* Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, and major vascular complications (Implanted).
** Composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak. (Based on Core Lab Assessment) (Intent-to-treat).

Presented by T. Feldman, MD at EuroPCR 2017 

 

 

View Recent LOTUS Valve Clinical Data Presentations

 
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