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
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
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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