September 2, 2020
Cardiac Dimensions’ Carillon System Approved in Australia for Treatment of Functional Mitral Regurgitation
September 2, 2020—Cardiac Dimensions announced that the company’s Carillon mitral contour system has received Therapeutic Goods Administration (TGA) regulatory approval in Australia.
The Carillon system is a right heart transcatheter mitral valve repair device designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+. The transcatheter procedure with the Carillon system is designed to reshape the mitral valve, reduce valve leakage, and thus reduce MR and induce favorable remodeling.
“The availability of the Carillon system is an extremely exciting advancement for the medical community as this technology has the potential to help millions of patients [with] heart failure and FMR,” commented David Kaye, MD, in the Cardiac Dimensions announcement. Dr. Kaye, who is Director of Cardiology at The Alfred Hospital, Melbourne, Australia, continued, “The Carillon system provides a new, nonsurgical method to correct a fundamental problem with the mitral valve in patients with heart failure. This approach has been shown to reduce MR and to favorably impact the left ventricle (LV). This is significant because a reduction in LV enlargement in heart failure is known to be associated with positive patient outcomes.”
According to the company, the Australian TGA’s approval was based on the combined efficacy and safety results from several Cardiac Dimensions’ studies, including the most recent REDUCE FMR study. In these studies, treatment with the Carillon mitral contour system consistently demonstrated a significant decrease in regurgitant volume and LV volumes. These changes were associated with reduced heart failure symptoms and improved quality of life.
The Carillon system has received CE Mark approval. In the United States, the device is limited to investigational use and is being studied in the CARILLON pivotal trial, which commenced in September 2018. To date, the Carillon system has been implanted in > 1,200 patients in the United States, Europe, Australia, Turkey, and the Middle East, stated the company.
In February 2020, the company announced that the findings of a post hoc analysis of pooled, prospectively collected data from three studies of the company’s Carillon mitral contour system were presented by Janusz Lipiecki, MD, in a late-breaking trials session at CRT 2020, the Cardiovascular Research Technologies congress and simultaneously published online by Dr. Lipiecki et al in Cardiovascular Revascularization Medicine (2020;21:712-716). The data from the TITAN, TITAN II, and REDUCE FMR clinical studies focused on the 5-year survival rate and the determinants of long-term survival. The findings confirmed the favorable long-term mortality benefit of the Carillon system, supporting the significant improvement in MR and favorable remodeling of the LV shown in REDUCE FMR.