LOTUS Edge?

Aortic Valve System

REPRISE III Clinical Trial

REPRISE III is the first head-to-head pivotal trial of two TAVR devices: the LOTUS? Valve and Evolut? R/CoreValve? platforms. Based on the results, LOTUS showed significantly lower moderate paravalvular leak (PVL), significantly lower disabling stroke and superior procedural outcomes.
REPRISE III Clinical Trial

Effectiveness and Safety Data

In the REPRISE III clinical trial, the LOTUS Valve showed superiority to Evolut R/CoreValve platform in the primary effectiveness endpoint at one year and non-inferiority in the primary safety endpoint at 30 days.

Primary Effectiveness Endpoint*?

Superiority P < 0.001

Primary Effectiveness Endpoint: 15.8% LOTUS Valve vs. 26.0% Evolut R/CoreValve

1-Year Primary Effectiveness Endpoint Components

1-Year Primary Effectiveness Endpoint Components
LOTUS VALVE SUPERIOR TO EVOLUT R/COREVALVE Primary effectiveness endpoint (1 year): Composite of all-cause mortality, disabling stroke, moderate or greater PVL. LOTUS Valve = 15.8% vs. Evolut R / CoreValve Platform = 26.0%. Superiority P < 0.001.
* As shown in REPRISE III, 1 year.
? Composite of moderate/severe PVL, disabling stroke and all death. N = 912.
? CoreValve platform is approximately ? CoreValve and ? Evolut R.
§ 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 based on intent to treat. Event rates for Primary Safety endpoint based on implanted valves.

Primary Safety Endpoint

Non-inferiority P < 0.003

Primary Safety Endpoint: 20.3% LOTUS Valve vs. 17.2% Evolut R/CoreValve

30 Days Primary Safety Endpoint Components

30 Days Primary Safety Endpoint Components
LOTUS VALVE NON-INFERIOR TO EVOLUT R/COREVALVE Primary safety endpoint (30 days): Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2/3 kidney injury, major vascular complications. LOTUS Valve = 20.3% vs. Evolut R / CoreValve Platform = 17.2%. Non-inferiority P = 0.003.
** 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 based on intent to treat. Event rates for Primary Safety endpoint based on implanted valves.

Superior Stroke Outcomes

As shown in the REPRISE III data, the LOTUS Valve demonstrated a significantly lower disabling stroke rate and a numerically lower overall stroke rate at one year.
REPRISE III Key Results LOTUS & Evolut R / CoreValve
IIT; KM Event Rate  ± 1.5 SE; log-rank P value. Feldman T, MD. A Prospective, Randomised Investigation of a Novel Transcatheter Aortic Valve Implantation System: The REPRISE III Trial; EuroPCR 2017; Paris, France.

Surgical-Like PVL

Surgical-Like PVL

Learn how our unique Adaptive Seal? and braided valve frame conform to each patient’s anatomy, virtually eliminating paravalvular leak.

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Stable Delivery

Stable Delivery

Discover how our exclusive deployment technology was designed to provide complete control, precise placement and stable deployment.

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100% Repositionable

100% Repositionable

Find out how LOTUS Edge enables you to assess final valve position after 100% deployment with the option to recapture and reposition.

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