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news.Cardiac Dimensions, a developer of cardiovascular devices, has received the CE Mark approval for its Carillon Mitral Contour System from KEMA Quality - a European Union notified body from the Netherlands.
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The Carillon system is a percutaneous treatment for functional mitral regurgitation. The CE Mark approval is an important milestone for Cardiac Dimensions, allowing the company to market the product in countries that accept CE Marking – primarily Europe. Cardiac Dimensions is now developing plans for commercialization in Europe.
The Carillon Mitral Contour System combines a proprietary implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. It is delivered percutaneously via jugular vein access under fluoroscopic guidance.
Prior to the receipt of the CE Mark approval, Cardiac Dimensions recently obtained ISO 13485 (2003) certification, which is an international standard for quality management systems for medical devices.
Paul Cornelison, the vice president of regulatory affairs and quality assurance at Cardiac Dimensions, said: The CE Mark approval represents the culmination of our efforts to establish a strong foundation of quality here at Cardiac Dimensions. The information used to support our CE Mark approval, together with the ISO certification, ensures that we will deliver products of the highest possible quality to our customers.