Results from TITAN trial of CARILLON Mitral Contour System to be presented at ESC 2010 Congress

Aug 18 2010

Cardiac Dimensions, an early stage company focused on the development of minimally invasive devices for the treatment of mitral valve disease and congestive heart failure, announced today that the 12-month follow-up results from the TITAN™ trial of the Company's CARILLON® Mitral Contour System will be presented at the European Society of Cardiology 2010 Congress (ESC) on August 29, 2010 in Stockholm.

Professor Dr. Uta Hoppe of the University of Cologne, Germany, will present the 12-month trial data and review the safety and efficacy of the CARILLON system, a novel therapy for treating heart failure patients suffering from functional mitral regurgitation (FMR), a disorder of the heart's mitral valve.

Most of the estimated 5 million people in the U.S. and more than 20 million people worldwide suffering from heart failure also suffer from FMR, along with dilated cardiomyopathy. Unfortunately, most of these patients have few options and are inadequately treated using medical management. While surgical options exist and can be effective in reducing FMR, they are infrequently used due to the burden of the surgery itself, which can be associated with high operative morbidity and mortality rates.

The CARILLON Mitral Contour System is a non-surgical, minimally invasive device designed to repair the mitral valve in these patients and reduce FMR. It combines a proprietary implantable device and a percutaneous delivery system.

The 12-month follow-up trial results are highly anticipated because the previously released six-month data presented at TCT 2009 was very promising, noted Professor Dr. Michael Haude of the Stadtische Kliniken Neuss, Lukaskrankenhaus, Germany, one of the study investigators along with Professor Dr. Hoppe.

"In my experience this device presents key advantages, such as an easy to learn technique and immediate assessment of efficacy coupled with peri-procedural recapturability, if necessary," Professor Dr. Haude said. "We found that the majority of patients experienced immediate clinical improvement, but importantly the clinical and hemodynamic improvement was sustained through the one year of follow-up.  The clinical data also suggests that the CARILLON device does not preclude later use of complementary therapies such as biventricular pacing."

The trial protocol evaluated the clinical impact of coronary sinus-based percutaneous mitral annuloplasty in symptomatic patients with both ischemic and non-ischemic dilated cardiomyopathy, at least moderate FMR, and stable medical therapy.  Anatomical exclusions were limited to those patients who had significant mitral leaflet pathology, or severe mitral annular calcification.  Safety was evaluated as the one month composite major adverse event (MAE) rate.  Hemodynamic efficacy was measured by an echocardiographic core lab, which assessed left ventricular dimensions, function, and quantitative measures of FMR.  Functional efficacy was assessed by exercise testing as well as quality of life metrics.  

The 12-month data to be presented at ESC will allow for a comparison between the implanted and control groups, an assessment of whether reverse remodeling is associated with FMR reduction, and an analysis of the durability of this percutaneous repair technique.

"We are confident that the long-term results of this latest trial of our CARILLON device will highlight the efficacy and durability of this mitral valve repair treatment," commented Rick Stewart, CEO of Cardiac Dimensions.  "We are very grateful to our group of clinicians who are working with us to bring hope to the literally millions of heart failure patients suffering from FMR who currently have very few options. We look forward to executing European commercialization of this therapy and pushing forward with the U.S. investigational plan."

Previously reported interim (six month) data revealed a 68 percent implant rate for the TITAN™ trial.  An important feature of the CARILLON® device is the ability to be recaptured, if necessary, peri-procedurally.  Fifteen percent of patients were not implanted because of transient coronary occlusion observed during the procedure allowing the device to be safely removed.  The device was also recaptured if significant FMR reduction could not be confirmed at the time of the procedure. There was one peri-procedural contrast related death in a non-implanted patient resulting in a 1.9 percent one month MAE rate.  Acute peri-procedural FMR reduction was confirmed by the echo core lab at 1 month.  By six months, the average reduction among four quantitative echo measures of FMR was 35 percent.  These hemodynamic results corresponded with an improvement in six-minute walk distance of greater than 100 meters and a one grade reduction in the NYHA class at six months in the implanted patient cohort.