MANNHEIM, Germany – April 26, 2019 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments to address functional mitral regurgitation (FMR) in patients with heart failure (HF), presented new data confirming significant reduction in regurgitant volume directly after implantation of the Carillon® Mitral Contour System® at the German Society of Cardiology annual congress, DGK 2019. The Carillon® System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+.
Prof. Dr. Andreas Hagendorff, Head of Laboratory of Echocardiography of the Department of Cardiology-Angiology at the University of Leipzig and renowned echo-cardiologist led the study. “Functional mitral regurgitation is associated with increased morbidity and mortality in patients with heart failure. For patients ineligible to receive surgical treatment, interventional techniques represent a new therapy option.” Prof. Hagendorff continued, “The findings we presented confirmed the acute hemodynamic effects of the Carillon® device on mitral valve morphology and demonstrated an acute reduction in a regurgitant fraction in 83% of patients, as documented by transthoracic echo after device implantation.”
“The significant acute MR benefit demonstrated in our study, achieved by a device that cinches the mitral apparatus via the coronary sinus without compromising the valve or future treatment options, makes the Carillon® System a front-line treatment option for FMR patients,” added Dr. Stephan Stoebe, co-author and presenter at DGK.
Presentations highlighting the Carillon® System this week during DGK 2019 include:
25 April 2019: New Devices and Therapies for Mitral Valve Insufficiency
Treatment of functional mitral regurgitation by the Carillon® Mitral Contour Device – an echocardiographic analysis of acute effects. S. Stöbe, K. Kreyer, U. Laufs, A. Hagendorff
26 April 2019: Functional MI in Heart Failure: Interventional Differential Therapie
Background on the Carillon® Mitral Contour System® & REDUCE FMR. H. Sievert
Carillon® Mitral Contour System® Live Case. M. Haude
Atrium-Triggered Annulus-Extension. M. Reinthaler
Combo-Cases – MitraClip & Carillon, Carillon® & MitraClip R. S. von Bardeleben
(select presentations from DGK 2019 can be found at DGK 2019 Presentations)
“We are pleased with the results from the University of Leipzig study validating the immediate impact of the Carillon® System on mitral regurgitation for a large percentage of FMR patients,” said Greg Casciaro, President and CEO of Cardiac Dimensions. “This study adds to the growing body of evidence demonstrating the effectiveness and safety of the Carillon System in two key measurements of FMR – a significant MR reduction and favorable left ventricular remodeling, observed most recently in the REDUCE FMR trial, the first and only randomized, blinded, sham-controlled trial conducted in structural heart.”
About the Carillon® Mitral Contour System
The Carillon® System offers a simple right-heart approach to transcatheter mitral valve repair (TMVr) designed to reshape the anatomy and improve the function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options.1,2 The Carillon® System is designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and reverse left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy 3,4,5.
The Carillon® System has CE Mark (0344) approval and has been implanted in over 950 patients in Europe, Australia, Turkey, and the Middle East. The Carillon® System is not approved for sale in the United States.
About Cardiac Dimensions, Inc.
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company is funded by Aperture Venture Partners, Arboretum Ventures, Difference Capital, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia, and Germany.
1. Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
2. Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
3. Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3: e000411.
4. Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
5. Sievert, H. 2018. REDUCE-FMR: A Sham Controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.