Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up. 2
Three-year mortality rate compared to published outcomes of COAPT and guideline directed medical therapy (GDMT), using matched patient populations, was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 55.5% for GDMT – Figure 1. 2
"Mitral regurgitation in the context of heart failure is strongly associated with increased morbidity and mortality," commented Steven L. Goldberg, MD, Tyler Heart Institute, Community Hospital of the Monterey Peninsula and Chief Medical Officer at Cardiac Dimensions. "We continue to see a growing body of evidence demonstrating the consistent effectiveness and safety of the Carillon System. The long-term data presented today suggests the primary clinical benefit of percutaneous mitral valve repair may be enhanced after the ventricle has had some time to remodel." He continued, "We have consistently seen improvements in left ventricular dimensions, which typically is associated with mortality benefits. One would therefore anticipate long-term benefits from a decrease in LV volume overload, and these data are supportive."

Gregory D. Casciaro, President and CEO of Cardiac Dimensions, commented, "This analysis of three important FMR clinical studies is the first to look at five-year follow-up and brings new insights into the long-term role of percutaneous treatment." He continued, "We are pleased the results confirm a favorable long-term mortality benefit of the Carillon System, supporting the significant improvement in MR and favorable remodeling of the left ventricle, as shown in REDUCE FMR. This reaffirms the effectiveness and safety of the Carillon System and underlines the value of early treatment to slow the deterioration of heart failure."

An estimated 26 million people, worldwide, suffer from heart failure3 and of those, approximately 70 percent have FMR. Heart failure is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.4

About the Carillon Mitral Contour System®
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair (TMVr) designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart's venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options.5,6 The Carillon System is designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy. 7,8,9

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