KIRKLAND, Wash.--(BUSINESS WIRE)--The CARILLON® Mitral Contour System® is projected to be a cost-effective treatment option when compared to a typical regimen of optimal medical treatment (OMT), the present standard of care for functional mitral regurgitation (FMR). This finding has been established in a new study published in BMC Cardiovascular Disorders.
Researchers analyzed data derived from the landmark TITAN clinical trial, which demonstrated significant clinical merits of the CARILLON technology, and developed a comprehensive cost-effectiveness model that projects the costs of the technology and compares them to the benefits. The output shows the CARILLON therapy to be cost-effective in comparison to OMT with an incremental cost-effectiveness ratio (ICER) of €15,533 per quality-adjusted life year (QALY).
ICER is considered to be a gold standard in terms of determining whether a new therapy is cost-effective with amounts below €35,000/QALY typically considered to be cost effective. The analysis was conducted from the perspective of the German health insurance system.
“In multiple clinical trials, CARILLON has demonstrated significant reductions in FMR and improvement in heart failure symptoms. This analysis takes the next step in projecting that these benefits result in the cost effectiveness of the therapy,” said Michael Haude, M.D. PhD, Chief of Cardiology at Lukaskrankenhaus in Neuss, Germany and co-author of the study. “This positive assessment has substantial implications in terms of the utility and accessibility of the therapy.”
About CARILLON® Mitral Contour System®
The CARILLON Mitral Contour System is a percutaneous mitral annuloplasty treatment option that can be deployed rapidly and safely1, utilizing standard interventional techniques. The implantable device consists of a distal anchor and a proximal anchor connected by a shaping ribbon and utilizes the heart’s venous anatomy to reshape the mitral annulus. This approach allows for reduction of the dilated annulus, addressing a root cause of functional mitral regurgitation (FMR). CARILLON has demonstrated compelling efficacy, significantly improving patients’ symptoms, mitral regurgitation and quality of life. In addition, all adjunctive treatment options remain available after using CARILLON, making it an ideal first-line therapy for FMR.
About Functional Mitral Regurgitation
An estimated 70 percent of the 26 million people worldwide with heart failure suffer from functional mitral regurgitation (FMR). FMR typically results from the dilation of the left ventricle, which is the main pumping chamber in the heart. As the left ventricle increases in size, the mitral valve also expands. This dimensional increase leads to mitral regurgitation, which significantly reduces the amount of blood flow out of the left ventricle and on to the body and its organs. FMR has been associated with high rates of mortality, reduced functional capacity, poor quality of life and an increase in patient hospitalizations. Current mainstream therapies to address FMR are limited. A majority of patients become refractory to medical therapy, which is the current standard of care and traditional surgical intervention is associated with high rates of operative morbidity and mortality.
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. The company’s initial technology platform, the CARILLON Mitral Contour System has been designed to address functional mitral regurgitation (FMR), utilizing a novel percutaneous approach. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany. For more information, visit the company’s web site: http://www.cardiacdimensions.com.
Cardiac Dimensions, CARILLON and Mitral Contour System are registered trademarks of Cardiac Dimensions.
1 Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg S, Mehta N, Solomon SD, Levy WC, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.