Boston Scientific initiates REPRISE III trial of Lotus Valve System for Aortic Stenosis to support US approval

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 Catheterization 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.

The initiation of the REPRISE III clinical trial marks the beginning of the process required to support FDA 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 percent of the population age 65 and older, and five percent of people older than 75. From the onset of symptomatic aortic stenosis, the average survival rate is 50 percent at two years and 20 percent 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.