January 26, 2009 - Cardiac Dimensions Inc. today said it achieved the implant target for the TITAN (TIghten The Annulus Now) safety study during the fourth quarter of 2008, which uses the CARILLON Mitral Contour System for percutaneous treatment of functional mitral regurgitation (FMR).
TITAN is a 30 patient study using the CARILLON Mitral Contour System, currently under investigational use in Europe, conducted at six centers in Germany, Poland and France and has a primary endpoint of safety as measured by major adverse events at 30 days. The study also has secondary endpoints of long term safety and the effect of the CARILLON implant on hemodynamics and subject function at one, six, 12, 18, and 24 months. Follow up for all patients is now ongoing.
The principal investigator Professor, Dr. Tomasz Siminiak from the Cardiac and Rehabilitation Hospital in Poznan is pleased with the results so far. “This is my second clinical study testing the CARILLON device. In both experiences, we have found the CARILLON to be an effective tool for the management of our patients. We have also seen tremendous growing interest on the part of referring physicians and heart failure patients around the country.” He also said, “The improvements to the system made by Cardiac Dimensions following the initial AMADEUS study have simplified the procedure significantly as well.”
According to Richard Van Bibber, Ph.D., director of research at Cardiac Dimensions, the company’s prior trials were critical. “In proctoring the cases for TITAN, we were able to apply a great deal of learning from our previous clinical trials. We saw a very wide range of disease in this study, but our investigators understood the procedure well after just a few cases, and our acute results were extremely encouraging.”
Cardiac Dimensions also said it will seek FDA approval.
About 5 million people in the U.S. and more than 20 million people worldwide suffer from heart failure. Most of these patients also suffer from dilated cardiomyopathy and functional mitral regurgitation (FMR), the majority of whom 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 combines a proprietary implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. It is delivered percutaneously via jugular vein access under fluoroscopic guidance. The implant is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve, thereby reducing mitral regurgitation. Preclinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements in other key parameters including NYHA class, six minute walk times and quality of life.
For more information: www.cardiacdimensions.com