Cardiac Dimensions® Inc. Receives ISO 13485:2003 Certification
The Standard Emphasizes Meeting Both Customer Requirements and Worldwide Regulatory Requirements
Cardiac Dimensions®, Inc. announced today that it has received ISO 13485:2003 certification from KEMA Quality B.V..a European Union Notified Body from the Netherlands. ISO 13485:2003 is an international standard for quality management systems, specifically for medical devices. The certification is an important measure of the company.s quality capabilities and is a key requirement in obtaining the CE Mark.
Paul Cornelison, Vice President of Regulatory Affairs & Quality Assurance, commented, "This certification validates the company's efforts to establish, document and maintain an effective quality management system," he said. "I am pleased that the entire company has been committed to achieving and maintaining this status."
"The ISO certification has been a key objective of ours," said Rick Stewart, Cardiac Dimensions' President and CEO. "It represents a validation of our high standards in terms of product design along with our manufacturing and distribution processes. We are also working toward gaining the CE Mark for our CARILLON™ system; this ISO certification provides a foundation to meet the specific quality requirements for the countries that accept CE Marking."
Approximately 5 million people in theU.S. and over 20 million people worldwide suffer from Heart Failure. Most of these patients also suffer from dilated cardiomyopathy and 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 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 along other key parameters including NYHA class, 6 Minute Walk Times and Quality of Life.
Cardiac Dimensions Inc., based in Kirkland, Washington, develops and manufactures devices designed for treating heart failure and related conditions.
Contacts
Cardiac Dimensions, Inc.
Tom Douthitt, 425-605-5900
www.cardiacdimensions.com