Third Multi-Center Study Shows Compelling Results Consistent with Previous Trials; Data Presented at TCT
KIRKLAND, Wash., Sept. 17, 2014 /PRNewswire/ — Cardiac Dimensions®, Inc. today announced that new long-term outcomes data from the TITAN II clinical trial of its enhanced CARILLON Mitral Contour System showed significant and sustained improvements in mitral regurgitation, functional improvement, quality of life and reverse cardiac remodeling. The long-term safety and efficacy data, which was consistent with previous trials of the system, was presented Sept. 13 at the 26th annual Transcatheter Cardiovascular Therapeutics Conference (TCT) in Washington, DC by TITAN II investigator Professor Dr. Michael Haude of Lukaskrankenhaus in Neuss, Germany.
TITAN II was a prospective, single-arm European multi-center clinical trial initiated to further evaluate an enhanced version of the CARILLON system. An innovative, 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 an abnormally enlarged mitral 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 were implanted with CARILLON devices and were followed for a one-year period as part of the TITAN II trial. Enrolled patients represented a severely ill advanced heart failure population at baseline, with an average New York Heart Association (NYHA) classification of III, an average left ventricular ejection fraction of 33 percent and an average mitral regurgitation grade of just under 3+.
Key findings from the study included:
• Significant reductions in FMR as assessed by multiple quantitative measures, including regurgitant volume, which decreased from 34.3 +13.8 ml to 20.6 +12.4 ml at 12 months (p<0.05).
• Eighty percent of patients experienced at least a one class improvement in NYHA classification from baseline to 12 months.
• Marked improvement in functional capacity with six-minute walk distances increasing from 294.1+82.6 to 381.6+130.3 meters at 12 months (p<0.01).
• A low 30-day major adverse event rate of 2.8 percent.
“This enhanced version of the CARILLON technology has performed superbly, demonstrating compelling outcomes and an impressive safety profile in an extremely sick patient population,” said Dr. Haude. “I was pleased to be able to present the results of the TITAN II trial to my cardiology colleagues at the TCT conference and am most encouraged by the fact that these positive outcomes are consistent with the previous two multi-center evaluations of the CARILLON system. With data from nearly 100 patients across three prospective trials, we have a conclusive basis from which to make the determination that CARILLON should be a first line treatment for patients suffering from FMR.”
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, which is the current standard of care 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 has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany. 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.
