Cardiac Dimensions Launches Carillon Mitral Contour System in Europe

September 28, 2012—Cardiac Dimensions, Inc. (Kirkland, WA) announced the European launch of the Carillon Mitral Contour System for the treatment of patients with functional mitral regurgitation (FMR).

As part of the commercial introduction, patients have been enrolled in the PRIME (Percutaneous Repair in Functional Mitral Regurgitation) study. PRIME is a prospective, multicenter postmarket registry that will evaluate long-term safety and efficacy through the assessment of hemodynamics, functional capacity, heart failure hospitalizations, and quality of life in up to 300 patients.

According to Cardiac Dimensions, the Carillon Mitral Contour System combines the company’s 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. Utilizing the heart's natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing FMR. The Carillon system is rapidly delivered via the venous vasculature and has the potential to treat most heart failure patients in a minimally invasive fashion. The data from PRIME will build on Cardiac Dimension’s AMADEUS, TITAN, and TITAN II studies. Clinical data suggests that usage is associated with significant reduction in FMR, and significant improvement in functional capacity and quality of life, the company stated.