Data Shows Safety, Efficacy of CARILLON® System; Paves Way for
(KIRKLAND, WA), May 21, 2012—Cardiac Dimensions®, Inc. today announced that data from its landmark TITAN clinical trial has been published in the most recent issue of the European Journal of Heart Failure. Titled "Treatment of Functional Mitral Regurgitation by Percutaneous Annuloplasty: Results of the TITAN Trial," the manuscript features two-year follow-up data on patients implanted with the CARILLON® Mitral Contour System® as well as one-year follow-up on a non-implanted concurrent comparison group. The CARILLON system is a novel therapy for treating heart patients suffering from functional mitral regurgitation (FMR) and has CE Mark approval, enabling commercialization in Europe.
TITAN (Transcatheter Implantation of CARILLON Mitral Annuloplasty Device) was a prospective, non-randomized, double-arm study evaluating CARILLON in FMR patients. The trial was designed to build upon the foundational results established in the AMADEUS (CARILLON Mitral Annuloplasty Device European Union Study) feasibility study. Fifty-three patients were enrolled in TITAN with 36 patients implanted with the CARILLON device and 17 serving as a non-implanted comparison group. Enrolled patients represented a severely ill advanced heart failure population at baseline, with an average New York Heart Association classification of 3, an average left ventricular ejection fraction below 30 percent and an average mitral regurgitation grade of 3+ to 4+.
Key findings from the study were as follows:
Implanted patients demonstrated significant reductions in FMR as assessed by multiple quantitative measures, including regurgitant volume, which decreased from 34.5±11.5 ml to 17.4±12.4 ml through 12 months (p<0.001).
Implanted patients experienced significant reverse remodeling with left ventricular diastolic and systolic volumes decreasing through 12 months, compared to progressive left ventricular dilation among the comparison group.
Marked improvement in functional capacity was observed among implanted patients through 24 months with six-minute walk distances increasing by 131.9±80 meters (p<0.001).
A 30-day major adverse event rate of 1.9 percent was demonstrated on an intent-to-treat basis.
Dimensions’ inception, we have been focused on delivering a therapeutic
modality that effectively addresses FMR via a safe and efficient
percutaneous approach," stated David Reuter, M.D., Ph.D., Chief Medical
Officer. "With the publication of the TITAN results, we now have substantial
evidence that we have achieved this objective. Patients who suffer from FMR
are a large and growing population with few viable options for treatment.
This manuscript serves as a major step forward in establishing CARILLON as
an important therapy, specifically targeted at this debilitating condition.
The strength of the data reflects the clinical evolution of the technology
and we are pleased to have partnered with some of the leading investigators
in the field in achieving these results. As an organization, these data
provide us with significant confidence as we initiate commercialization in
About CARILLON® Mitral Contour System®
Cardiac Dimensions’ CARILLON Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilizing the heart’s natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation (FMR). Rapidly delivered via the venous vasculature, CARILLON has the potential to treat most heart failure patients in a minimally invasive fashion. Clinical data suggests that usage is associated with significant reduction in FMR, and significant improvement in functional capacity and quality of life.
About Functional Mitral Regurgitation
More than 20 million people worldwide have heart failure, most of whom also suffer from functional mitral regurgitation (FMR). FMR typically results from the dilation of the left ventricle, which is the main pumping chamber in the heart. As the left ventricle increases in size, the mitral valve also expands. This dimensional increase leads to mitral regurgitation, which significantly reduces the amount of blood flow out of the left ventricle and on to the body and its organs. FMR has been associated with high rates of mortality, reduced functional capacity, poor quality of life and an increase in patient hospitalizations. Current mainstream therapies to address FMR are limited. A majority of patients become refractory to medical therapy over time and traditional surgical intervention is associated with high rates of operative morbidity and mortality.
About Cardiac Dimensions®, Inc.
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, utilizing a novel percutaneous approach. Cardiac Dimensions is based in Kirkland, Washington. For more information, visit the company’s web site: http://www.cardiacdimensions.com.
Cardiac Dimensions, CARILLON and Mitral Contour System are registered trademarks of Cardiac Dimensions, Inc.