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.”