Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management
Guidelines support the Carillon Mitral Contour System® for the treatment of heart failure patients with secondary functional mitral regurgitation
KIRKLAND, WA — Sept. 22, 2021 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the mention of their Carillon Mitral Contour System in the 2021 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. In addition, the Carillon Mitral Contour System can now be considered under the new Class IIb 2021 Guidelines for the Management of Valvular Heart Disease recommendations on indications for mitral valve intervention in chronic severe secondary mitral regurgitation. Both guidelines were recently published in the European Heart Journal.
The latest guidelines, referring to the Carillon Mitral Contour System, state that other percutaneous mitral valve repair systems, such as indirect annuloplasty, are available for treatment of secondary mitral regurgitation (SMR). The guidelines also state the approach has a shorter learning curve, fewer technical requirements than percutaneous edge-to-edge mitral valve repair and does not preclude different procedures once it is performed. The section in the guidelines continues with reference to Cardiac Dimensions’ REDUCE FMR trial that was blinded, sham-controlled and randomized, and met its primary endpoint of mitral regurgitant volume reduction with reverse left ventricle remodeling at 12 months.
The guidelines go on to reference additional Cardiac Dimensions’ studies that confirm the favorable results of the Carillon Mitral Contour System on left atrium volumes and left ventricle remodeling with trends towards improvement in clinical measures, and a reduction in heart failure hospitalizations. Given the newly introduced option of “other percutaneous therapies” in the valvular disease guidelines and being the only non-TEER device mentioned in the heart failure guidelines, the Carillon Mitral Contour System can now be considered the only other non-TEER Class IIb option in the treatment of SMR.
“I’m very pleased to see the Carillon Mitral Contour System mentioned in the 2021 ESC heart failure guidelines,” commented Professor Dr. Horst Sievert, Director of the Cardiovascular Center in Frankfurt and the Director of Internal Medicine, Cardiology and Vascular Medicine of the Sankt-Katharinen-Hospital. “And even more exciting is to have the allowance for other transcatheter valve therapy in the 2021 ESC valve guidelines with the Carillon device the only other device mentioned for use. With so few options available for my SMR patients, it is great to see additional options added to the guidelines.”
The guidelines are considered an important tool for the evaluation of heart failure patients with valvular heart disease in Europe. They provide relevant information on each disease discussed along with a highly didactic approach to and algorithms for the management of patients. Until recently, the paradigm of treatment for SMR focused on medical management of symptoms, yet promising evidence now points to the role transcatheter device treatment options can play today and in the future.
Percutaneous transcatheter techniques for the improvement of SMR have broadened the spectrum of patients who may benefit from mitral valve intervention. The most recent guidelines propose an updated practical approach to the management of patients with heart failure and SMR based on a multidisciplinary Heart Team approach and have started to broaden the tools allowed to treat patients.
“Being the only device, other than TEER, mentioned in the 2021 ESC guidelines for the treatment of secondary mitral regurgitation is a testament to our excellent clinical data and the overwhelming need for additional treatment options in the space,” said Rick Wypych, Cardiac Dimensions President and Chief Executive Officer. “We’ve already seen, with the unveiling of the guidelines, more hospitals becoming aware of the Carillon Mitral Contour System as an important option in the treatment of their patients.”
An estimated 26 million people, worldwide, suffer from heart failure1 and of those, approximately 49 percent have SMR2. Heart failure is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 20303.
For a copy of the “2021 European Society of Cardiology Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure,” please visit: https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehab368/6358045
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 in a safe and effective manner. 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 can also be used alongside other heart failure treatments should they be needed.
To date, over 1,500 patients have been treated with the Carillon System throughout the world. Clinical data from over 250 patients in four previously completed studies of the Carillon System have provided the basis for demonstrating the safety and performance of the Carillon device as well as for the related CE Mark, which allows for commercial sales in Europe. Additionally, the U.S. pivotal study, The EMPOWER Trial, is currently enrolling patients in the U.S. as well as select centers worldwide.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation 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 secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.
The Carillon Mitral Contour System is approved for sale in Europe through its CE Mark and is an investigational device in the U.S. For more information, please visit cardiacdimensions.com.
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NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.