Cardiac Dimensions has announced that its Carillon mitral contour system, for the treatment of functional mitral regurgitation (FMR) has received certification under the EU’s Medical Device Regulation (MDR).
The MDR programme is intended to ensure high standards of safety and quality of medical devices that are produced in, or supplied to, member countries of the EU.
According to the most recent data published by the European Commission last December, fewer than 10% of products holding a certificate under the predecessor program, the Medical Devices Directive (MDD), had received MDR certification.
“I am proud of our team, who committed significant time and resources to ensuring our device and systems achieved the new high standards set by the EU, ahead of many in our industry,” said Cardiac Dimensions CEO Rick Wypych. “The excellent safety profile of the Carillon device coupled with the significant body of high-quality evidence supporting the Carillon therapy were key factors in achieving MDR certification. This milestone signals to our physician partners and patients that they can be confident in the safety and manufacturing excellence of the Carillon system.”
“The Carillon device has the unique ability to both improve FMR symptoms and remodel the heart. MDR certification of the Carillon mitral contour system will ensure continued and uninterrupted access to this evidence-based treatment option for heart failure patients with FMR in Europe,” said Klaus Witte, Chair of Cardiac Device Therapy, University of Aachen (Aachen, Germany).