KIRKLAND, Wash., March 8, 2013 /PRNewswire/ -- Cardiac Dimensions®,Inc. today announced that it has completed enrollment in its TITAN II clinical trial, a follow-up to the landmark TITAN clinical trial of the Company's CARILLON® Mitral Contour System®. TITAN II is a prospective, single-arm European multi-center clinical trial initiated to further evaluate an enhanced version of the CARILLON system. A novel, minimally-invasive therapy, the CARILLON system is designed to treat heart failure patients suffering from functional mitral regurgitation (FMR), a condition in which blood flow to the body is reduced due to a poorly functioning heart valve. An estimated 70 percent of the 20 million people worldwide with heart failure also suffer from FMR.
A total of 30 patients across five sites have been implanted with the CARILLON system and will be followed for a one-year period as part of the TITAN II trial. Patients will be evaluated for improvements in mitral regurgitation, functional capacity, quality of life and reverse cardiac remodeling.
Published in the European Journal of Heart Failure, data from TITAN suggest that patients implanted with the CARILLON system experienced significant relief from FMR and improvements in functional capacity and quality of life compared to a contemporaneously-enrolled comparison group.
"The early clinical data from TITAN II is very promising," stated Rick Stewart, Chief Executive Officer. "The implant rate increased substantially and the early data validate the impressive results that were observed in TITAN as well as reinforce the product enhancements we completed in 2011. We are most grateful to our investigators for their leadership throughout the study and look forward to the opportunity to present the complete TITAN II data set in the near future."
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.
For further information contact:
Cardiac Dimensions, Inc.
Allen & Caron, Inc.
SOURCE Cardiac Dimensions, Inc.