Structural Heart > LOTUS Edge™ Aortic Valve System > TAVI Clinical Outcomes

TAVI Clinical Trials

We are dedicated to advancing the science of transcatheter aortic valve replacement. That’s why we have implanted the LOTUS™ Valve platform in over 2,000 patients – and counting. The REPRISE III data demonstrate superior outcomes and we are currently enrolling patients in the REPRISE IV FDA clinical trial. Through ongoing research and development, we are committed to evolving TAVI valve technology and the entire TAVI procedure.

Proven Clinical Outcomes*

In REPRISE III, the first head-to-head pivotal TAVI trial, the LOTUS Valve platform demonstrated significantly lower moderate paravalvular leak (PVL), significantly lower disabling stroke rate and superior patient outcomes.

REPRISE III Safety and Efficacy Data

The REPRISE III data demonstrate that the LOTUS Valve platform showed superiority to the 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 Components at 1 Year

Primary Effectiveness Endpoint Components at 1 Year

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.

Primary Effectiveness Endpoint

Superiority P < 0.001

 

Primary Safety Endpoint Components at 30 Days

Primary Safety Endpoint Components at 30 Days

LOTUS Valve Superior 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.

Primary Safety Endpoint

Non-inferiority P = 0.003

 

 
 

LOTUS Edge Design

See how the LOTUS Edge Aortic Valve System was designed to offer surgical-like PVL, consistent delivery and 100% respositionability.

 
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Indications, Safety and Warnings
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