Cardiac Dimensions has received CE mark approval for its carillon mitral contour system, a novel therapy for treating heart failure patients suffering from functional mitral regurgitation (FMR).
The mitral contour system consists of a proprietary, implantable device with a percutaneous catheter delivery system.
The approval is backed by Amadeus and Titan clinical trials of the Carillon system, which demonstrated reduction in FMR and improvement in functional capacity and quality of life.
Another study, called Titan II, was recently initiated to further the clinical experience.
Commercial launch of the device in Europe will begin in 2012, the company said.