Cardiac Dimensions reported new data confirming significant reduction in regurgitant volume directly after implantation of its Carillon Mitral Contour System at the German Society of Cardiology annual congress, DGK 2019.
The Kirkman, WA-based company’s Carillon System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+. The findings presented in the study confirmed the acute hemodynamic effects of the Carillon device on mitral valve morphology and demonstrated an acute reduction in regurgitant fraction in 83% of patients, as documented by transthoracic echo after device implantation.
Greg Casciaro, President and CEO of Cardiac Dimensions, said the study helped validate the immediate impact of the Carillon System on mitral regurgitation for a large percentage of FMR patients.
"This study adds to the growing body of evidence demonstrating the effectiveness and safety of the Carillon System in two key measurements of FMR - a significant MR reduction and favorable left ventricular remodeling, observed most recently in the REDUCE FMR trial, the first and only randomized, blinded, sham-controlled trial conducted in structural heart,” Casciaro said in a release.
Cardiac Dimensions has been building itself up as a powerful competitor in the FMR market. A year ago, the company raised $39 million to build strong clinical evidence for its Carillon Mitral Contour System. And in September of last year, Cardiac Dimensions launched its pivotal trial.