LOTUS Edge?

Aortic Valve System

TAVR Clinical Outcomes

As part of our commitment to advancing the science of transcatheter aortic valve replacement procedures, we have implanted the LOTUS? Valve in approximately 2,000 patients at 160 sites around the world. The REPRISE III clinical trial data demonstrated superior outcomes and we are currently enrolling patients in the REPRISE IV FDA study, which will evaluate LOTUS Edge outcomes in patients at intermediate surgical risk and those with a native bicuspid valve.  
TAVR Clinical Outcomes

LOTUS Valve Platform Clinical Program

Lotus Clinical Program Chart
 * LOTUS (N = 607); CoreValve? (N = 305)
 

LOTUS Trial Data

REPRISE III Clinical Trial

Explore the results from REPRISE III, the first head-to-head TAVR pivotal trial of 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.

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LOTUS Edge Study

See the data from the LOTUS Edge Study, which combines results from two single-arm studies with similar protocols and identical core labs designed to evaluate the safety and performance of the LOTUS Edge Aortic Valve in high-surgical-risk patients with symptomatic calcific aortic stenosis.

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Sub-Analyses

Explore the sub-analyses of LOTUS Valve clinical trial data, including stroke, paravalvular leak (PVL) and permanent pacemaker (PPM) rates.

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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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