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 & Quality Assurance at Cardiac Dimensions, stated, “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 13485 (2003) certification, ensures that we will deliver products of the highest possible quality to our customers.”
“I am extremely pleased with the company’s performance this past year, as we have hit every major milestone we envisioned at the beginning of the year,” stated Rick Stewart, President and CEO of Cardiac Dimensions. “We have continually focused on advancing our quality system with the goal of being best in class. We obtained our ISO certification and ultimately received the very important CE Mark approval, putting us in the position of being able to pursue commercialization of the device. We completed enrollment in another multi-center trial in Europe, and the results of all studies so far have exceeded our expectations,” He adds, “we are looking forward to working closely with FDA as our clinical strategy shifts towards a final pivotal trial here in the U.S.”
Approximately 5 million people in the U.S. and over 20 million people worldwide suffer from Heart Failure. Most of these patients also suffer from dilated cardiomyopathy and functional mitral regurgitation (FMR); the majority of whom are inadequately treated using medical management. While surgical options exist and can be effective in reducing FMR, they are infrequently used due to the burden of the surgery itself, which can be associated with high operative morbidity and mortality rates.
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. 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, thereby reducing mitral regurgitation. Preclinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements in other key parameters including NYHA class, 6 Minute Walk distances and Quality of Life.
Cardiac Dimensions®, Inc., based in Kirkland, Washington, develops and manufactures devices designed for treating heart failure and related conditions.
For further information contact Tom Douthitt at (425) 605-5900 or visit Cardiac Dimensions®, Inc. website at www.cardiacdimensions.com