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LOTUS Edge™

Aortic Valve System

LOTUS Clinical Overview

REPRISE III Clinical Trial

PVL-STROKE-PPM Data

PVL Rates Across Studies

LOTUS has consistently demonstrated surgical-like PVL rates in clinical studies. The latest content presented on LOTUS Edge shows a 97.1% rate of None/Trace PVL, as presented at PCR London Valves 2018.
LOTUS Edge PVL features

REPRISE III Trial: Analysis of Predictors of Stroke

As shown in the REPRISE III data, the LOTUS Valve showed a significantly lower disabling stroke rate and a numerically lower overall stroke rate, at one year.
  LOTUS Evolut R / CoreValve P Value
Stroke 7.5% 9.8% P = 0.28
Disabling Stroke 4.0% 7.4% P = 0.03
Presented by A. Linke, MD at EuroPCR 2018

In this analysis, predictors of late stroke included:

Multivariate analysis including baseline parameters only

  P Value
Ejection Fraction 0.01
Treatment with Evolut R / CoreValve 0.01

 

Multivariate analysis including 30-day parameters

Mild or Greater PVL at 30 days 0.005
Ejection Fraction 0.03
SOV area (cm2) 0.049
Presented by A. Linke, MD at EuroPCR 2018
Rates of Mild or Greater PVL at 30 days were four times lower with LOTUS.
Rates of Mild or Greater PVL at 30 days were four times higher with Evolut R / CoreValve.
Presented by R. Makkar, MD at PCRLV 2017

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

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SAFARI2™ Pre-Shaped TAVR Guidewire
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*Includes comparison of number of patients with mild PVL [P < 0.0001] and patients with moderate or greater PVL [P < 0.0001] treated with LOTUS vs.  Evolut R/CoreValve. 

Asch F, Mani V, Singh A, et al. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. CIRCULATIONAHA.2018;118.034129, originally published March 12, 2018

LOTUS™ Significantly Lower PVL than Evolut™ R / CoreValve™ in the High Calcium Cohort of the REPRISE III Trial

In the REPRISE III High Calcium Cohort, the LOTUS Valve platform had significantly lower PVL than Evolut R / CoreValve in patients with high calcium burden. This data is consistent with the superior PVL performance of LOTUS in the broader REPRISE III Trial.
Significantly Lower PVL than Evolut™ R / CoreValve™
 

LOTUS™ Valve PPM Rate

Data shows a downward trend in Permanent Pacemaker Rate (PPM)
1 Presented by V Falk, MD at PCR 2016 
2 Presented by D. Blackman, MD at PCR 2017 
3 Presented by D. Walters, MD at ACC 2017
 
Data shows a downward trend in Permanent Pacemaker Rate (PPM)
1 Presented by V Falk, MD at PCR 2016 
2 Presented by D. Blackman, MD at PCR 2017 
3 Presented by D. Walters, MD at ACC 2017
LOTUS Edge overview
See the latest REPRISE III Data
View the LOTUS Valve Platform clinical program
View SAFARI2™ Pre-Shaped TAVR Guidewire 
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