KIRKLAND, Wash.--(BUSINESS WIRE)--Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address patients suffering from heart failure with functional mitral regurgitation (FMR), today announced that its Carillon Mitral Contour System® has received certification under Regulation (EU) 2017/745 (“MDR”).
The MDR program 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 Prof. Klaus Witte, Chair of Cardiac Device Therapy, University of Aachen.
About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy preserves the integrity of the mitral valve to allow for other FMR treatments should they be needed.
The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Europe and Australia. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure with functional mitral regurgitation (FMR). Left untreated, FMR contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.
