Newly Published Data Confirm the Safety and Efficacy of the Carillon® Mitral Contour System®
KIRKLAND, Wash.–(BUSINESS WIRE)– New data from the TITAN II™ trial, the third multi-center trial evaluating the Carillon Mitral Contour System, confirm the safety and efficacy of the device in the treatment of functional (secondary) mitral regurgitation (FMR) – a condition that occurs in approximately 70 percent of heart failure patients.
According to data published in Open Heart, an official journal of the British Cardiovascular Society on July 8, 2016, 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 MD, PhD 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. “
“With three prospectively controlled multi-center trials evaluating the Carillon system completed, we have great confidence about the performance of this therapy in the FMR patient population,” said Gregory D. Casciaro, President and Chief Executive Officer of Cardiac Dimensions®. “ TITAN II confirmed the excellent clinical results observed in our previous studies. These positive outcomes add to the growing body of evidence in support of the Carillon device and underscore the need for this percutaneous treatment option, which has the potential to help millions of people who suffer from FMR.”
The Carillon system is now being evaluated in the landmark REDUCE FMRTM 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. More than 500 patients have been treated with the Carillon device worldwide.
About the Carillon Mitral Contour System
The leading transcatheter mitral annuloplasty device, the Carillon Mitral Contour System is uniquely designed to treat FMR. The Carillon 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. The Carillon system has demonstrated compelling efficacy, significantly improving patients’ symptoms, mitral regurgitation and quality of life. In addition, all adjunctive treatment options remain available after placement of a Carillon device, making it an ideal first-line therapy for FMR.
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. The company’s initial technology platform, the Carillon Mitral Contour System has been designed to address functional mitral regurgitation (FMR), utilizing a novel percutaneous approach. The Carillon system has demonstrated positive results across three prospective multi-center clinical trials. Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Offenbach, Germany.
Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.