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Cardiac Dimensions Completes Patient Enrollment In TITAN Safety Study

Cardiac Dimensions, Inc. has achieved the implant target for the TITAN safety study during the fourth quarter of 2008. TITAN (TIghten The Annulus Now) is a 30 patient study conducted at 6 centers in Germany, Poland, and France. The study 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 and subject function implant on hemodynamics at 1, 6, 12, 18, and 24 months. Follow up for all patients is now ongoing. CARILLON Mitral Contour System is currently under investigational use in Europe. The system that combines a proprietary implantable device and delivery system is used for percutaneous treatment of functional mitral regurgitation (FMR). CARILLON Mitral Contour System implant consists of a shaping ribbon between distal and proximal anchors. The implant 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, 6 Minute Walk Times and Quality of Life.