LOTUS Edge™

Valve System

LOTUS™ Valve Superior to CoreValve®*

In Primary Efficacy Endpoint **

LOTUS Valve = 15.4%  v. CoreValve Platform = 25.5%
Superiority P < 0.001

Presented by T. Feldman MD at EuroPCR 2017

View the data highlights here.
Or read the full deck as presented at EuroPCR

Superior PVL performance with significantly lower PVL.


Presented by T. Feldman MD at EuroPCR 2017

 

Superior procedural outcomes with a signifcantly lower disabling stroke rate.


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

The LOTUS™ Valve System is a controlled mechanical expansion TAVI technology, designed to provide unmatched freedom from PVL, precise delivery and deployment, and predictable results.

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.

30 Day Results from the LOTUS Edge Feasibility Trial Presented at ACC 2017

Poster presented by D. Walters, MD at ACC 2017
30-day results from the LOTUS Edge Feasibility Trial suggest that the advantages of the first-generation LOTUS Valve System are conserved with the next generation LOTUS Edge Valve System with 100% technical success, 95% none or trace PVL, and low VARC events. The PPM rate of 10.5% provides an initial indication that the Depth Guard feature, which is intended to enable predictable placement, early anchoring during deployment, minimal depth of valve frame and a reduced interaction with the LVOT, may effectively reduce the PPM rate. Due to the limited size of cohort studied in the LOTUS Edge Feasibility Trial, further investigation of LOTUS Edge is ongoing.
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