Cardiac Dimensions today touted a clinical study of its Carillon mitral contour system in treating the primary cause of functional mitral regurgitation (FRM) in patients with heart failure.
Carillon is a right heart transcatheter mitral valve repair (TMVR) device designed to treat FRM in patients with mitral regurgitation grades of 2+, 3+ and 4+ in heart failure.
The blinded, multi-center, randomized, sham-controlled clinical trial included 120 patients enrolled across 31 sites in Europe, Australia and New Zealand. Three out of four patients who were on heart failure medical therapy with FMR were treated with the Carillon system.
The study concluded that treatment with Carillon resulted in a statistically significant reduction of mitral regurgitant volume, as the Carillon group’s MR volume dropped 7.1 mL, compared to an increase of 3.3 mL in the control group. Left ventricular volumes also decreased in the Carillon group (-10.4 mL) while they increased in the control (+6.5 mL).
Patients treated with the Carillon device experienced 48% fewer heart failure hospitalizations during follow-up, according to the study.
The new study was published in the Journal of the American College of Cardiology: Heart Failure. In April, the Kirkland, Wash.-based company touted data from a previous study on the Carillon device, which has held CE Mark approval in Europe since 2011.
“We are pleased with the outcome of the Reduce FMR study and the significant benefit the Carillon system brings to patients,” Cardiac Dimensions president & CEO Gregory Casciaro said in a news release. “This study adds to the growing body of evidence demonstrating the effectiveness and safety of the Carillon system for FMR patients and underlines the value of treating earlier in the disease to slow the deterioration of heart failure. We are leveraging these positive clinical results, along with the German DRG reimbursement and expansion to other EU markets, to quicken the commercial adoption of the Carillon system.”
“We know that mitral regurgitation in the context of heart failure is strongly associated with increased morbidity and mortality,” added Dr. Horst Sievert, director and founder of the Cardiovascular Center, Frankfurt. “Carillon provides an option to treat a large portion of FMR patients with a minimally invasive treatment that doesn’t compromise the valve leaflets. Patients across a wide spectrum of MR grade and (heart failure) class benefited from Carillon treatment, experiencing significant improvements in MR and favorable remodeling of the left ventricle. Heart failure is a progressive disease and we need options that allow for progressive treatment.”