Three studies cover 228 patients, 204 patients and 10 years
Cardiac Dimensions published three new studies on the Carillon Mitral Contour System on 7 July 2026, adding five-year registry data, a 204-patient single-centre analysis and 10-year survival results. The company announced the papers from Kirkland, Washington.
Carillon is the only commercially available indirect mitral annuloplasty device for functional mitral regurgitation, a condition often linked to heart failure. According to Cardiac Dimensions, the papers form the largest evidence base yet assembled for transcatheter indirect mitral annuloplasty.
Across the three manuscripts, researchers reported five-year multi-centre durability, broad real-world use and survival through 10 years. The datasets also covered patients with heart failure with reduced ejection fraction, or HFrEF, and preserved ejection fraction, or HFpEF.
In the CINCH FMR registry, 228 patients were followed in what Cardiac Dimensions called the largest multi-centre dataset for indirect mitral annuloplasty in contemporary practice. Nearly half remained free from heart failure hospitalisations through five years.
Moderate-to-severe mitral regurgitation fell from 84% at baseline to 9% at one year and stayed low through year five. More than 97% of patients kept a stable or improved mitral regurgitation grade at every measured time point.
Device- or procedure-related serious adverse events were 1.8% in the registry. Dr. William T. Abraham said the results show sustained symptom gains, lower mitral regurgitation and a strong safety profile in everyday practice.
204-patient single-centre analysis
A separate single-centre study reviewed 204 patients across both HFrEF and HFpEF. In that cohort, 94% improved by at least one New York Heart Association, or NYHA, class, and 98% reached NYHA class I or II.
Researchers also recorded improvements in BNP levels, left atrial size, pulmonary pressures, diastolic filling pressures and vena contracta width. Results did not differ between reduced and preserved ejection fraction groups.
Abraham called the consistency across HFrEF and HFpEF especially meaningful. He said the combined evidence shows Carillon has become a proven and reliable option for patients with functional mitral regurgitation.
10-year REDUCE FMR follow-up
The third paper reported long-term outcomes through 10 years from a single-centre extension of the REDUCE FMR trial. It found 66% cardiovascular survival and a median survival of 5.6 years in an elderly, high-risk functional mitral regurgitation population.
Meanwhile, Cardiac Dimensions is preparing regulatory submissions in the United States and expanding its commercial presence in Europe. The Carillon Mitral Contour System already has CE Mark and is sold in Europe and other markets that recognise CE Mark.
In the United States, Carillon remains an investigational device. It is under study in the EMPOWER Trial, a prospective, randomised, sham-controlled pivotal study that plans to enrol up to 300 patients.
