Sets Stage for Expanded Adoption Of CARILLON® Mitral Contour System®
(KIRKLAND, WA), February 19, 2014—Cardiac Dimensions®, Inc. today announced that the Company’s CARILLON® Mitral Contour System® has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1 approval across 120 leading hospitals in Germany, a decision from German regulators that may positively influence reimbursement from insurance companies for the costs of CARILLON procedures.
An innovative, minimally-invasive therapy, the CARILLON system is designed to treat heart failure patients suffering from functional mitral regurgitation (FMR), a condition in which blood flow to the body is reduced due to a poorly functioning heart valve. An estimated 70 percent of the 20 million people worldwide with heart failure also suffer from FMR.
“This positive reimbursement decision signifies an important step forward toward having CARILLON incorporated into the German DRG system,” stated Rick Stewart, Chief Executive Officer. “It is also emblematic of the strong clinician interest we are seeing in Europe and will be the basis for the significant expansion of our commercialization efforts. We look forward to increasing our collaboration with the German clinical community and broadening the availability of our therapy to additional patients suffering from functional mitral regurgitation.”
The approval was granted under the German Institute for the Hospital Remuneration System (InEK) NUB program for facilitating the introduction of innovative technologies that address underserved patient populations. The NUB program provides therapies with a streamlined path to inclusion in the German DRG system. With a designation of Status 1, the 120 approved hospitals may now request reimbursement from their associated insurance companies to cover the costs of CARILLON Mitral Contour System procedures. Only one other implantable cardiac device had more than 100 hospitals receive this designation for 2014.
About CARILLON® Mitral Contour System®
Cardiac Dimensions’ CARILLON Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilizing the heart’s natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation (FMR). Rapidly delivered via the venous vasculature, CARILLON has the potential to treat most heart failure patients in a minimally invasive fashion. Clinical data suggests that usage is associated with significant reduction in FMR, and significant improvement in functional capacity and quality of life.
About Functional Mitral Regurgitation
More than 20 million people worldwide have heart failure, most of whom also 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®, Inc.
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, utilizing a novel percutaneous approach. Cardiac Dimensions is based in Kirkland, Washington. 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, Inc.
For further information contact:
Cardiac Dimensions, Inc. Allen & Caron, Inc.
Omari Bouknight Len Hall
(425) 605-5960 (949) 474-4300
