Cardiac Dimensions has received CE Mark approval for its Carillon mitral contour system from KEMA Quality, a European Union Notified Body in the Netherlands.
The Carillon system is a percutaneous treatment for functional mitral regurgitation, according to the company. The system combines a proprietary implantable device and delivery system.
The implant consists of a shaping ribbon between distal and proximal anchors, and is delivered via jugular vein access under fluoroscopic guidance. It is designed to be positioned, adjusted and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve, thereby reducing mitral regurgitation.
Prior to the receipt of the CE Mark approval, Cardiac Dimensions said it recently obtained ISO 13485 (2003) certification.
The Kirkland, Wash.-based company said it is now developing plans for commercialization in Europe.