Cardiac Dimensions announced that it has initiated European commercialisation of its Carillon Mitral Contour System used in the treatment of patients suffering from functional mitral regurgitation (FMR).
As part of the commercial rollout, the patients have been enrolled in the PRIME (Percutaneous repair in functional mitral regurgitation) study, a prospective, multicentre post-market study registry that builds on the clinical experience from Cardiac Dimensions’ AMADEUS, TITAN and TITAN II studies. Long-term safety and efficacy will be evaluated in the PRIME study through the assessment of haemodynamics, functional capacity, heart failure hospitalisations as well as quality of life in up to 300 patients.
About Carillon Mitral Contour System
The Carillon Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. Utilising the heart’s natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation (FMR).