Cardiac Dimensions Announces Two New Meta-Analysis Publications Showing Statistically Significant and Clinically Meaningful Benefits to Heart Failure Patients Suffering from Functional Mitral Regurgitation
KIRKLAND, WA – April 7, 2021 — Cardiac Dimensions announced a published second individual patient data meta‐analysis demonstrating clinically significant outcomes for the Carillon Mitral Contour System®. This publication, in addition to the several others recently published on the Carillon device, continues the series of excellent results for this transcatheter-based indirect annuloplasty device.
Both of the published meta-analyses were conducted from three prospective, core lab reviewed, CEC/DSMB adjudicated and third-party monitored clinical studies which enrolled a total of 209 heart failure patients with reduced ejection fraction and functional mitral regurgitation (FMR). These data were published in the ESC Heart Failure Journal.
In the previously published, first meta-analysis,1 which was focused on patient echocardiographic data, the authors concluded “This comprehensive meta‐analysis of individual patient data has shown that Carillon device provides statistically significant and clinically meaningful benefits on MR severity, LA and LV volumes, and remodeling and rates of subsequent heart failure hospitalization” at 12 months as compared to baseline measures. Professor Andrew Coats, recent Director of the Monash Warwick Alliance and Academic Vice-President, Monash and Warwick Universities and senior author on the publication said, “The findings of this paper are very compelling, consistent with other published Carillon results and would indicate the Carillon device should be seriously considered in the treatment of this ever-growing patient population.”
The second meta-analysis, based on the same patient population, follows a different path which concentrated more on the clinical outcomes of patients. The results from this publication showed significant improvement in 6-minute walk test (6MWT) distance and Kansas City Cardio-myopathy Questionnaire (KCCQ) score at 1 and 12 months from baseline. In addition, more than 50% of the patients had improvements in KCCQ score of greater than 5 points at 12 months and a greater than one class improvement in New York Heart Association (NYHA) classification out to 12 months. Importantly, these positive results remained similar for the parameters analyzed when reviewing the subset of the MR 1+ and 2+ population as compared to the MR 3+ or 4+ population.2
“Heart failure patients often suffer from reduced quality-of-life and compromised physical function, which is why improving their quality-of-life end points should be the primary consideration,” commented Professor of Cardiology Dr. Stefan Anker, Charité University, and an author on the second meta-analysis. “Our patients don’t care if they have regurgitant volume when they come to the hospital. Their focus is around symptoms, quality-of-life, hospitalizations and, as the ultimate goal, long-term survival.”
These new meta-analyses add to the wide range of recently published materials on the Carillon device. These have included rigorous clinical outcome analysis of the landmark REDUCE FMR Trial3 (the first-ever randomized, blinded, sham-controlled study in the transcatheter mitral valve space) results which highlighted a substantially higher number of patients achieved minimum clinically important differences at 12 months as compared to the sham procedure in 6MWT, KCCQ, NYHA class and reduced heart failure hospitalization.4 Notably, recent publications have also included data on long-term patient survival including one which reported 56% survival through 5 years.5
Dr. Janusz Lipiecki, an interventional cardiologist at Pôle Santé République, in Clermont-Ferrand, France, and lead author on the long-term prognosis publication said, “Given medical management of these heart failure patients results in a survival rate of 45% at three years, the 67.9% rate of survival for patients receiving the Carillon device at three years is compelling while the 56% survival rate at five years is simply impressive.”
“These publications, as well as all our others, represent our dedication to high quality clinical data and our continued efforts to make the Carillon device the primary device in the treatment of heart failure patients,” said Rick Wypych, President and CEO of Cardiac Dimensions. “We continually demonstrate a strong positive relationship between the Carillon device and improving the quality-of-life metrics our patients care about. This data shows we are breaking new ground and are excited to advance our unique FMR treatment.”
About the Carillon Mitral Contour System®
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair designed to reshape the anatomy and 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. The Carillon System is designed to treat the primary cause of functional mitral regurgitation in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy. The Carillon System is CE-marked (0344) and has been used by physicians in the U.S., E.U., Australia, Turkey and the Middle East. The Carillon System is currently being studied in The CARILLON Trial U.S. pivotal study and limited to investigational use in the United States.
About Cardiac Dimensions
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’s lead investors include Aperture Venture Partners, Arboretum Ventures, 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. For more information, visit cardiacdimensions.com.
- Giallauria F, et al., Individual patient data meta‐analysis of the effects of the CARILLON® mitral contour system. ESC Heart Failure.
- Khan MS, et al., Effect of Carillon Mitral Contour System on patient‐reported outcomes in functional mitral regurgitation: an individual participant data meta‐analysis. ESC Heart Failure.
- Witte K, et al., A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. JACC Heart Fail.
- Khan MS, et al., Functional outcomes with Carillon device over 1 year in patients with functional mitral regurgitation of Grades 2+ to 4+. ESC Heart Failure.
- Lipiecki J, et al., Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovasc Revasc Med.
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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.