KIRKLAND, Wash., Sept. 29, 2011 /PRNewswire/ -- Cardiac Dimensions®, Inc. today announced that it has received Conformite Europeenne (CE) Mark approval for a newly enhanced version of its CARILLON® Mitral Contour System', a novel therapy for treating heart failure patients suffering from functional mitral regurgitation (FMR). Receipt of the CE Mark enables Cardiac Dimensions to initiate a commercial launch of the enhanced device in Europe, which the Company noted will begin in 2012.
The CE Mark approval follows the successful completion of the AMADEUS and TITAN clinical trials of the CARILLON system, which demonstrated significant reduction in FMR and significant improvement in functional capacity and quality of life. An additional trial with the enhanced version of CARILLON, called TITAN II, was recently initiated to further the clinical experience.
"We are delighted to have achieved this critical milestone, which allows us to distribute CARILLON throughout Europe," said Rick Stewart, President and Chief Executive Officer of Cardiac Dimensions. "We believe CARILLON's novel approach to addressing FMR holds significant promise for the millions of heart failure patients who suffer from this debilitating and progressive condition. The CE Mark approval of CARILLON is a reflection of our rapidly growing clinical experience, which suggests that this device is uniquely positioned to reverse the course of heart failure in this largely under-addressed patient population. Also, we are pleased to have the opportunity to further substantiate our initial clinical experiences through the commencement of the TITAN II trial."
Janusz Lipiecki, M.D., of Clinique Pole Sante Republique in Clermont Ferrand, France, one of the TITAN and TITAN II investigators, commented: "FMR secondary to left ventricular dilatation is associated with poor prognosis and high rates of mortality. As a new treatment option, CARILLON offers compelling and unique attributes given its rapid percutaneous deployment and innovative use of natural cardiac structures to reduce mitral annulus dimension. The elegance and ingenuity behind the design allow for customization based on patient anatomy as well as intra-operative assessment to ensure safety. From a clinical perspective, patients have experienced early and sustained improvements that suggest profound utility. I am pleased to hear of the recent CE Mark approval and excited to serve as a TITAN II investigator and further contribute to the clinical experience."
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. Early clinical data suggest 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 and most of them 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 over time 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 and CARILLON are registered trademarks of Cardiac Dimensions, Inc., and Mitral Contour System is a trademark of Cardiac Dimensions, Inc.
For further information contact: | ||
Cardiac Dimensions, Inc. | Allen & Caron, Inc. | |
David Reuter | Len Hall | |
(425) 605-5960 | (949) 474-4300 | |
SOURCE Cardiac Dimensions, Inc.
