Cardiac Dimensions has initiated two new clinical studies using the CARILLONR Mitral Contour System, an investigational device for percutaneous treatment of functional mitral regurgitation (FMR). The CARILLON system is a minimally invasive device designed to repair the heart's mitral valve and reduce FMR.
The INTEGRAL Trial will assess safety and efficacy of the CARILLON device at one, three, six and 12 months by evaluating reduction in FMR, heart size and corresponding improvements in exercise capacity. The TITAN II study of the CARILLON Mitral Contour System is an extension of the company's recent TITAN trial.
Cardiac Dimensions also announced that Adrian Ebner, M.D., the principal investigator of the INTEGRAL trial, successfully performed the first implant using the CARILLON system. Dr. Ebner performed the procedure at the Italian Hospital in Asuncion, Paraguay on a 32-year-old man with moderate mitral regurgitation (MR) caused by his dilated cardiomyopathy.