COMPANY GETS IDE FOR MITRAL REGURGITATION TRIAL

The FDA has granted Cardiac Dimensions investigational device exemption (IDE) approval to initiate its COMPETENT pilot study of the CARILLON Mitral Contour System for treatment of mitral insufficiency in patients suffering from heart failure.

The company plans to conduct the COMPETENT trial at eight centers throughout the U.S. Cardiac Dimensions is also sponsoring a parallel safety study at seven centers in Europe called AMADEUS. This trial recently received ethics committee approvals in Europe and has already begun enrolling patients at several centers in Europe. Prior to IDE approval, the CARILLON Mitral Contour System has undergone extensive pre-clinical evaluation, and features of the device have been tested in a small "acute" trial in Australia.

The CARILLON Mitral Contour System consists of a shaping ribbon between distal and proximal anchors. The device is delivered percutaneously via jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral regurgitation.