Cardiac Dimensions announced that it has received CE mark approval for a newly enhanced version of its Carillon mitral contour system, a novel therapy for treating heart failure patients suffering from functional mitral regurgitation.
The CE mark approval follows the successful completion of the AMADEUS and TITAN clinical trials of the Carillon system, which demonstrated significant reduction in functional mitral regurgitation and significant improvement in functional capacity and quality of life. An additional trial with the enhanced version of Carillon, called TITAN II, was recently initiated to further the clinical experience.
Janusz Lipiecki, Clinique Pole Sante Republique in Clermont Ferrand, France, and one of the TITAN and TITAN II investigators, commented, “Functional mitral regurgitation secondary to left ventricular dilatation is associated with poor prognosis and high rates of mortality. As a new treatment option, Carillon offers compelling and unique attributes given its rapid percutaneous deployment and innovative use of natural cardiac structures to reduce mitral annulus dimension. The elegance and ingenuity behind the design allow for customisation based on patient anatomy as well as intra-operative assessment to ensure safety. From a clinical perspective, patients have experienced early and sustained improvements that suggest profound utility.”
“We believe Carillon’s novel approach to addressing functional mitral regurgitation holds significant promise for the millions of heart failure patients who suffer from this debilitating and progressive condition. The CE mark approval of Carillon is a reflection of our rapidly growing clinical experience, which suggests that this device is uniquely positioned to reverse the course of heart failure in this largely under-addressed patient population. Also, we are pleased to have the opportunity to further substantiate our initial clinical experiences through the commencement of the TITAN II trial,” said Rick Stewart, president and CEO of Cardiac Dimensions.
The company announced the device’s European commercial launch to begin in 2012.
About Carillon mitral contour system
Carillon combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilising the heart’s natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation. Rapidly delivered via the venous vasculature, Carillon has the potential to treat most heart failure patients in a minimally invasive fashion.