Feature | October 02, 2014

Boston Scientific Enrolls First Patients in U.S. Trial of Lotus Valve System

Data from REPRISE III clinical trial designed to support U.S. regulatory approval

October 2, 2014 — Boston Scientific Corp. 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. Ted E. Feldman, M.D., director, cardiac catheterization laboratory, NorthShore University HealthSystem, 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 study. The Lotus valve system is the first transcatheter aortic valve replacement (TAVR) device that is both fully repositionable and retrievable prior to release.

A clinical team led by Feldman implanted the first three Lotus 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 U.S. Food and Drug Administration (FDA) premarket approval.

Aortic valve stenosis, the process of thickening and stiffening in the valve that results in a reduction in blood flow, 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.

"New data from REPRISE I and REPRISE II, which were presented last week at Transcatheter Cardiovascular Therapeutics (TCT) 2014 in Washington, D.C., demonstrate remarkably low rates of paravalvular leakage and all-cause mortality," said Feldman. "We believe that REPRISE III, which is slated to involve more than 1,000 patients, will confirm these data and show the Lotus valve system has the potential to improve patient outcomes beyond what we've seen with first-generation devices."

REPRISE III is a randomized, 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 [investigational device exemption] trial marks an important step in bringing this innovative technology to physicians and patients in the United States," 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."

For more information: www.bostonscientific.com

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