2008-05-08 23:58:11 -
- Cardiac Dimensions(R), Inc. Tom Douthitt, 425-605-5900 www.cardiacdimensions.com Cardiac Dimensions(R), Inc. today announced it has completed its European AMADEUS(TM) study. AMADEUS(TM) (CARILLON(TM) Mitral Annuloplasty Device European Union Study) was a 30 patient safety and performance study of the CARILLON(TM) Mitral Contour System(TM) conducted at 6 centers in Germany, Poland, and the Netherlands. The study met its primary safety endpoint at
6 months, along with its secondary performance endpoints at 6 months. The complete results will be presented at the European Society of Cardiology (ESC) later this year by principal investigator Prof. Dr. med Joachim Schofer.
Commenting on AMADEUS(TM), Prof. Schofer stated, "Throughout this study, both the investigators and the company learned a great deal about the percutaneous treatment of FMR, which is a tremendous unmet clinical need. As the device evolved and the investigators' technique was perfected, we found the CARILLON(TM) to be an effective and extremely simple tool for the management our patients."
The CARILLON(TM) system is a percutaneous treatment of functional mitral regurgitation (FMR), currently under investigational use in Europe, South America, and Australia only.
"This company was founded with the intent to deliver the best solution to the problem of functional mitral regurgitation along the parameters of safety, effectiveness, and simplicity," stated Rick Stewart, President and CEO of Cardiac Dimensions. "The successful completion of AMADEUS is a major milestone for Cardiac Dimensions Inc. We could not be happier with the data, and we now turn our attention to enrollment in our new TITAN(TM) study."
Approximately 5 million people in the U.S. and over 20 million people worldwide suffer from Heart Failure. The majority of these patients also suffer from dilated cardiomyopathy and FMR. The vast majority of these patients are inadequately treated using medical management. While surgical options exist and can be effective in reducing FMR, they are infrequently used due to the burden of the surgery itself, which can be associated with high operative morbidity and mortality rates.
The CARILLON(TM) Mitral Contour System(TM) combines a proprietary implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. The device is delivered percutaneously via jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted, and gently anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral regurgitation. Preclinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements along other key parameters including NYHA class, 6 Minute Walk Times, and Quality of Life. However, these results are preliminary, and require additional study.
Cardiac Dimensions(R), Inc., based in Kirkland, WA, develops and manufactures devices designed for treating heart failure and related conditions.
¶ Six Month Follow Up Completed for Investigation of the
CARILLON(TM) Mitral Contour System(TM), a Percutaneous Approach for
the Management of Functional Mitral Regurgitation (FMR)