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news.Cardiac Dimensions has completed its European Amadeus study, a 30 patient safety and performance study of the Carillon Mitral Contour System conducted at six centers in Germany, Poland, and the Netherlands.
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The study met its primary safety endpoint at six months, along with its secondary performance endpoints at six months. The Carillon system is a percutaneous treatment of functional mitral regurgitation (FMR), currently under investigational use in Europe, South America, and Australia only.
Prof. med Joachim Schofer, principal investigator of the study, said: “Throughout this study, both the investigators and the company learned a great deal about the percutaneous treatment of FMR, which is a tremendous unmet clinical need. As the device evolved and the investigators’ technique was perfected, we found the Carillon to be an effective and extremely simple tool for the management our patients.”