Safety and efficacy of Carillon mitral contour system confirmed

Carrilon system
Carrilon system

According to a study published in Open Heart, treatment with the Carillon device (Cardiac Dimensions) significantly reduces annular dimensions and improved mitral regurgitation, heart failure symptoms, and functional capacity in patients with functional mitral regurgitation. These data, from the third multicentre study (TITAN II) of the system, confirm the safe and efficacy of the Carillon device.

A press release reports that TITAN II trial was a prospective, single-arm, multicentre study (undertaken at five centres in Germany, Poland and France). The study’s results show a decrease in heart failure hospitalisations in the one-year follow-up period, after a Carillon device was implanted, compared with the year prior to implantation. Two prior multicentre studies—AMADEUS and TITAN—using the Carillon system have also provided compelling evidence of safety and efficacy of the system. In total, more than 100 patients functional mitral regurgitation have now been evaluated in multicentre studies featuring the Carillon device.

TITAN II lead investigator Janusz Lipiecki (Pôle Santé République, Clermont-Ferrand, France), says: “This is the second multicentre study featuring the Carillon device in which I have participated and I have become more impressed with how the therapy improves symptoms and quality of life in these patients by addressing annular dilatation, a root cause of functional mitral regurgitation. The minimally-invasive nature and simplicity of the Carillon system make it an extremely important therapy for this otherwise under-addressed, severely ill heart failure population.”

According to the press release, the Carillon system is now being evaluated in the landmark REDUCE FMR trial—the first randomised, blinded evaluation of a therapy for functional mitral regurgitation. The trial will enrol 120 patients at 25 centres in Europe, Australia and New Zealand, with the goal of establishing the Carillon system as the gold standard therapy for functional mitral regurgitation.