TITAN II Data Published for Cardiac Dimensions' Carillon Mitral Contour System

July 19, 2016—Cardiac Dimensions announced that new data from the TITAN II trial, the third multicenter trial evaluating the company’s Carillon mitral contour system, confirm the safety and efficacy of the device in the treatment of functional mitral regurgitation (FMR). Janusz Lipiecki, MD, et al published the findings online in Open Heart, a journal of the British Cardiovascular Society.

According to Cardiac Dimensions, the study demonstrates that treatment with the Carillon device significantly reduced annular dimensions and improved mitral regurgitation, heart failure symptoms, and functional capacity in patients with FMR. The results also show a decrease in heart failure hospitalizations in the 1-year follow-up period when compared to the year before to implantation. These improvements were similar to those seen in previous studies.

The TITAN II trial was a prospective, single-arm, multicenter study, undertaken at five centers in Germany, Poland, and France. Two previous multicenter studies (AMADEUS and TITAN) using the Carillon system also provided compelling evidence of safety and efficacy. In total, more than 100 FMR patients have now been evaluated in multicenter studies featuring the Carillon device, noted the company.

Dr. Lipiecki, who is TITAN II’s Lead Investigator, commented in the company’s announcement, “This is the second multicenter study featuring the Carillon device in which I have participated and I’ve become more impressed with how the therapy improves symptoms and quality of life in these patients by addressing annular dilatation, a root cause of FMR. 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.” Dr. Lipiecki is from Pôle Santé République, Clermont-Ferrand, France.

The Carillon system is now being evaluated in the landmark REDUCE FMR trial, a randomized, blinded evaluation of a therapy for FMR. The trial will enroll 120 patients at 25 centers in Europe, Australia, and New Zealand, with the goal of establishing the Carillon system as the gold standard therapy for FMR, stated the company.

The Carillon system has received CE Mark approval and is commercially available in the European Union. The device is not approved for use in the United States.