IDE Approved for Pivotal Study of Cardiac Dimensions' Carillon Mitral Contour System

December 1, 2016—Cardiac Dimensions announced US Food and Drug Administration (FDA) approval of its application for an investigational device exemption (IDE) for its pivotal CARILLON trial. The multicenter, blinded, randomized controlled trial is designed to evaluate the company's Carillon mitral contour system versus guideline-directed medical management for the treatment of symptomatic functional mitral regurgitation (FMR) associated with heart failure.

The CARILLON trial is designed to enroll 400 patients at up to 50 centers in North America, Europe, and Australia. The trial has primary safety and efficacy endpoints at 12 months and will follow patients to document long-term safety. The company advised that the Carillon system has been studied in three multicenter, prospective clinical trials conducted in Europe, and successfully achieved endpoints of low event rates and reduction of regurgitant volume in all studies. The Carillon system has received CE Mark approval and is available in Europe, Australia, New Zealand, and the Middle East. The system is not approved for sale in the United States.

Martin B. Leon, MD, Chairman of the trial's clinical steering committee, commented in the company's announcement, "This CARILLON trial is an important next step to potentially advance the treatment of patients with functional mitral regurgitation. There is a significant need for a new minimally invasive solution for this extremely ill and underserved patient population, as current mainstream therapies are limited." Dr. Leon is Professor of Medicine and Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, New York.

Samir Kapadia, MD, one of the Principal Investigators of the CARILLON trial, added, "The Carillon device is unlike any other mitral regurgitation therapy. It offers patients annular reduction and keeps adjunctive therapy options open. I am excited to participate in this important pivotal trial and look forward to the results." Dr. Kapadia is Professor of Medicine and Director of the Sones Catheterization Laboratories at Cleveland Clinic in Cleveland, Ohio.

Another clinical trial, REDUCE FMR, is currently recruiting participants and is designed to enroll 120 patients at approximately 25 centers in Europe, Australia, and New Zealand. Cardiac Dimensions announced commencement of REDUCE FMR in June 2015.