LOTUS Edge™

Aortic Valve System

PVL Rates Across Studies

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

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.
Presented by R. Makkar, MD at PCR LV 2017 

PVL Rates Across Studies

  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.

The Lotus™ Valve System / LOTUS Edge™ Valve System is not available for sale in the European Economic Area. For educational purposes only.

TAVI Portfolio

*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.
New data shows a downward trend in New Permanent Pacemaker Rate (PPM)
Presented by R. Makkar, MD at PCR LV 2017 

LOTUS™ Valve PPM Rate

Data shows a downward trend in Permanent Pacemaker Rate (PPM)
Presented by R. Makkar, MD at PCR LV 2017 
 
1 Presented by V Falk, MD at PCR 2016 
Presented by D. Blackman, MD at PCR 2017 
3 Presented by D. Walters, MD at ACC 2017

 

 

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