Boston Scientific Corporation has initiated the REPRISE III clinical trial, a pivotal study to evaluate the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis and who are considered to be at either high or extreme risk for surgical valve replacement.  The Lotus Valve System is the first transcatheter aortic valve replacement (TAVR) device that is both fully repositionable and retrievable prior to release.  

Ted E. Feldman, M.D., director, Cardiac Catheterisation Laboratory, NorthShore University HealthSystem in Evanston, Ill., and Michael Reardon, M.D., professor of cardiothoracic surgery at The Methodist DeBakey Heart & Vascular Center in Houston, are co-principal investigators of the REPRISE III study.

A clinical team led by Dr. Feldman implanted the first three Lotus Valve Systems this week at Evanston Hospital as part of the REPRISE III clinical trial.  The initiation of the REPRISE III clinical trial marks the beginning of the process required to support US Food and Drug Administration premarket approval.

Aortic valve stenosis is the process of thickening and stiffening in the valve, which results in a reduction in blood flow.  It is a common problem affecting approximately three per cent of the population age 65 and older, and five per cent of people older than 75.  From the onset of symptomatic aortic stenosis, the average survival rate is 50 per cent at two years and 20 per cent at five years.  The REPRISE III trial aims to build on strong data from the REPRISE I and REPRISE II clinical studies, which have demonstrated sustained safety and performance outcomes for the Lotus Valve System.

"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," said Dr. Feldman.  "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."

REPRISE III is a randomised, open-label study assessing the Lotus Valve System against an active comparator (CoreValve TAVR System).

The primary endpoints of the study are, Safety: composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage two or three acute kidney injury or major vascular complications at 30 days.

Efficacy: composite of all-cause mortality, disabling stroke or moderate or greater paravalvular aortic regurgitation (leaking) at one year following procedure.

"Completing the first patient implantations of the Lotus Valve System as part of the REPRISE III IDE trial marks an important step in bringing this innovative technology to physicians and patients in the U.S.," said Tom Fleming, vice president and general manager, Structural Heart, Boston Scientific.  "It demonstrates the commitment of Boston Scientific to building upon a body of clinical evidence and advancing care for patients who suffer from this debilitating disease."

The Lotus Aortic Valve System is a differentiated second-generation TAVI technology, consisting of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve.  The low-profile delivery system is designed to enable predictable and precise placement associated with early valve function, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant.  Rapid pacing is not required during implantation. The device also features a unique Adaptive Seal designed to minimise the incidence of paravalvular regurgitation, which has been identified as a predictor of mortality in multiple clinical trials.

In the US, the Lotus Valve System is an investigational device and not available for sale.  It is CE marked in the European Union.