July 20, 2016 — New data from the TITAN II trial confirm the safety and efficacy of the Carillon Mitral Contour System in the treatment of functional (secondary) mitral regurgitation (FMR).
The Carillon System, a transcatheter mitral annuloplasty device, can be deployed rapidly and safely, utilizing standard interventional techniques. The device is placed using a non-surgical, minimally invasive (catheter-based) technique in a vein on the outside of the heart that is adjacent to the mitral valve. This simple procedure is designed to reshape the mitral valve annulus, reduce valve leakage and thus reduce mitral regurgitation.
According to data published in Open Heart, an official journal of the British Cardiovascular Society, on July 8, 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 one-year follow-up period when compared to the year prior to implantation. These improvements were similar to those seen in prior studies.
The TITAN II trial was a prospective, single-arm, multi-center study, undertaken at five centers in Germany, Poland and France. Two prior multi-center 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 multi-center studies featuring the Carillon device.
“This is the second multi-center 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,” said lead investigator Janusz Lipiecki, M.D., Ph.D., from Pôle Santé République, Clermont-Ferrand, France. “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. “
The Carillon system is now being evaluated in the landmark REDUCE FMR Trial, the first 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.
The Carillon system has received CE Mark approval and is commercially available in the European Union.
For more information: www.cardiacdimensions.com