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Cardiac Dimensions® Announces Presentation of 12-Month Follow-up Data of TITAN™ Trial at European Society of Cardiology Meeting
Date:8/18/2010

rability, if necessary," Professor Dr. Haude said. "We found that the majority of patients experienced immediate clinical improvement, but importantly the clinical and hemodynamic improvement was sustained through the one year of follow-up.  The clinical data also suggests that the CARILLON device does not preclude later use of complementary therapies such as biventricular pacing."

The trial protocol evaluated the clinical impact of coronary sinus-based percutaneous mitral annuloplasty in symptomatic patients with both ischemic and non-ischemic dilated cardiomyopathy, at least moderate FMR, and stable medical therapy.  Anatomical exclusions were limited to those patients who had significant mitral leaflet pathology, or severe mitral annular calcification.  Safety was evaluated as the one month composite major adverse event (MAE) rate.  Hemodynamic efficacy was measured by an echocardiographic core lab, which assessed left ventricular dimensions, function, and quantitative measures of FMR.  Functional efficacy was assessed by exercise testing as well as quality of life metrics.  

The 12-month data to be presented at ESC will allow for a comparison between the implanted and control groups, an assessment of whether reverse remodeling is associated with FMR reduction, and an analysis of the durability of this percutaneous repair technique.

"We are confident that the long-term results of this latest trial of our CARILLON device will highlight the efficacy and durability of this mitral valve repair treatment," commented Rick Stewart, CEO of Cardiac Dimensions.  "We are very grateful to our group of clinicians who are working with us to bring hope to the literally millions of heart failure patients suffering from FMR who currently have very few options. We look forward to executing European commercialization of this therapy and pushing forward with the U.S. investigational plan."

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SOURCE Cardiac Dimensions, Inc.
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