Cardiac Dimensions’ Carillon Mitral Contour System Receives European MDR Certification

April 25, 2023—Cardiac Dimensions, a developer of minimally invasive treatments for heart failure with functional mitral regurgitation (FMR) based in Kirkland, Washington, announced that its Carillon mitral contour system has received certification under the European Union’s (EU) Medical Devices Regulation (MDR)—(EU) 2017/745.

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. The most recent data published by the European Commission in December indicated that fewer than 10% of products holding a certificate under the predecessor program, the Medical Devices Directive, had received MDR certification, noted the company.

“The Carillon device has the unique ability to both improve FMR symptoms and remodel the heart,” commented Professor Klaus Witte, MD, in the company’s press release. “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.” Prof. Witte is Chair of Cardiac Device Therapy at University of Aachen in Aachen, Germany.

According to the company, the minimally invasive Carillon system was developed to treat patients with mitral valve insufficiency. The device is an 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 system has European CE Mark approval and was first launched in Europe in 2012. In 2020, the company announced that Australia’s Therapeutic Goods Administration approved the Carillon system for commercial use in FMR patients with mild to severe MR.

In the United States, Carillon mitral contour system is an investigational device and is not available.

Cardiac Dimensions recently announced it has closed a $35 million Series D financing round, which will be used for enrollment in the EMPOWER pivotal study of the Carillon device in the United States. The EMPOWER trial commenced in the summer of 2021.