REPRISE III US Pivotal Trial Begins for Boston Scientific's Lotus TAVR System

September 23, 2014—Boston Scientific Corporation announced that it has initiated the REPRISE III clinical trial. REPRISE III is a pivotal study to evaluate the safety and effectiveness of Boston Scientific’s Lotus transcatheter aortic valve replacement (TAVR) system in patients with severe aortic stenosis who are considered to be at either high or extreme risk for surgical valve replacement. The Lotus TAVR device is both fully repositionable and retrievable before release.

Ted E. Feldman, MD, and Michael Reardon, MD, are coprincipal investigators of the REPRISE III study. Dr. Feldman is Director, Cardiac Catheterization Laboratory, at NorthShore University HealthSystem in Evanston, Illinois. Dr. Reardon is Professor of Cardiothoracic Surgery at The Methodist DeBakey Heart & Vascular Center in Houston, Texas.

A clinical team led by Dr. Feldman implanted the first three Lotus valve systems 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. In the United States, the Lotus valve system is an investigational device and not available for sale. In Europe, the device received CE Mark approval and was launched in October 2013.

REPRISE III is a randomized, open-label study assessing the Lotus valve system against an active comparator, the CoreValve TAVR system (Medtronic, Inc.). The primary endpoints of the study are safety (composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications at 30 days) and efficacy (composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation at 1 year after the procedure).

The company stated that 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. Data from the REPRISE I and REPRISE II clinical trials of the Lotus valve system were presented at the 26th Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC.

In Boston Scientific’s press release, Dr. Feldman commented, “New data from REPRISE I and REPRISE II, which were presented last week at TCT 2014 in Washington, DC, 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.”

According to Boston Scientific, the Lotus system is second-generation TAVR technology consisting of a preloaded, 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 bidirectional atraumatic repositioning and retrieval at any time before release of the aortic valve implant. Rapid pacing is not required during implantation. The device also features a unique Adaptive Seal designed to minimize the incidence of paravalvular regurgitation, which has been identified as a predictor of mortality in multiple clinical trials.