Commercial Rollout includes PRIME Study, Collecting Data on up to 300 European Patients
(KIRKLAND, WA), September 28, 2012—Cardiac Dimensions®, Inc. today announced that it has initiated its commercial efforts in Europe, treating the first patients with its CARILLON® Mitral Contour System® under its Conformité Européenne (CE) Mark approval. The CARILLON system is a novel, minimally invasive therapy for treating heart patients suffering from functional mitral regurgitation (FMR). An estimated 70 percent of the 20 million people worldwide with heart failure also suffer from FMR.
As part of the commercial rollout, the patients have been enrolled in the PRIME (Percutaneous Repair in Functional Mitral Regurgitation) Study, a prospective, multicenter post-market study registry that builds on the clinical experience from Cardiac Dimensions’ AMADEUS, TITAN and TITAN II studies. Long-term safety and efficacy will be evaluated in the PRIME study through the assessment of hemodynamics, functional capacity, heart failure hospitalizations as well as quality of life in up to 300 patients.
To support commercial efforts, Cardiac Dimensions has established direct operations in Europe, including a dedicated sales and clinical team focused exclusively on the successful rollout of the CARILLON system.
“Initiation of commercial sales represents a major milestone for Cardiac Dimensions,” stated Rick Stewart, Chief Executive Officer. “We have spent the last few months preparing our organization for successful training, sales, distribution and clinical support of the CARILLON technology and are receiving a very warm reception from our early physician customers. In addition to general excitement around the minimally invasive CARILLON treatment, our physicians have also expressed a strong interest in participating in additional clinical studies. With the compelling outcomes expressed in TITAN and early positive signals coming from TITAN II, this bodes well as we begin the PRIME study.”
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 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, CARILLON and Mitral Contour System are registered trademarks of Cardiac Dimensions, Inc.
