LOTUS Edge™

Aortic Valve System

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
LOTUS Valve = 16.7%  v. CoreValve Platform = 29.0%     Superiority P < 0.001

Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.

Accessories

* 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 

 

 

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

LOTUS Valve = 19.0%  v. CoreValve Platform = 16.2%     Non-inferiority P < 0.001

* 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 Safety endpoint based on Implanted valves and not intent to treat.

Presented by T. Feldman, MD at EuroPCR 2017 

 

 

REPRISE III Key Results

LOTUS & Evolut R / CoreValve
N = 607      N = 305
REPRISE III Key Results LOTUS & Evolut R / CoreValve

* Composite of all-cause mortality, stroke, life-threatening and major bleeding, stage 2 and 3 AKI and major vascular complications (implanted)
† Implanted, binary event rates
‡ Composite of all-cause mortality, disabling stroke & moderate or greater paravalvular leak (PVL, core lab assessment, intent-to-treat)
§ ITT, binary event rates
** ITT, time-to-event rates

1y and 30d data presented by T. Feldman, MD at EuroPCR 2017
2y data presented by M. Reardon, MD at TCT 2018

 

 

Watch the Principal Investigators Talk about the REPRISE III Data Highlights

REPRISE III is the first Head to Head Pivotal Trial of two TAVR devices, LOTUS  Valve and Evolut R / CoreValve. This trial evaluated the safety and effectiveness of both devices in a high risk patient population. Results of the trial highlight some of the unique design features of the LOTUS Valve. View trial details in the video below.

 

 

REPRISE III Data Highlights

 

 

Superior ≥ Moderate PVL Performance with Significantly Lower PVL

Presented by T. Feldman, MD at EuroPCR 2017

 

 

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 Placement Procedural Outcomes

The LOTUS Valve is designed to allow full valve assessment before release and to be repositionable after 100% valve deployment.  The LOTUS Valve had significantly lower:
Presented by T. Feldman, MD at EuroPCR 2017

 

 

View Recent LOTUS Valve Clinical Data Presentations

 

 

 

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