US-based Boston Scientific has commenced REPRISE III clinical trial, a pivotal study that will assess the safety and efficacy of the Lotus Valve System in patients with severe aortic stenosis.
REPRISE III is a randomized and open-label study, which will evaluate the Lotus Valve System against an active comparator (CoreValve TAVR System).
The Lotus Valve System is the first transcatheter aortic valve replacement (TAVR) device, which is fully repositionable and retrievable prior to release, noted Boston Scientific.
The system, which features second-generation TAVI technology, comprises pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve.
NorthShore University HealthSystem cardiac catheterization laboratory director Ted Feldman said: "New data from REPRISE I and REPRISE II, which were presented last week at TCT 2014 in Washington, D.C., demonstrate remarkably low rates of paravalvular leakage and all-cause mortality.
"We believe that REPRISE III, which is slated to involve more than 1,000 patients, will confirm these data and show that the Lotus Valve System has the potential to improve patient outcomes beyond what we’ve seen with first generation devices."
As part of the REPRISE III clinical trial, a clinical team led by Feldman has implanted the first three Lotus Valve Systems at Evanston Hospital.
The trial has been designed to support US food and Drug Administration (FDA) premarket approval.