Healthcare Industry News:  mitral valve 

Devices Interventional Cardiology

 News Release - May 4, 2009

SCAI Highlights Cardiac Dimensions Inc AMADEUS Study as an Important "Late Breaking" Clinical Trial

Breakthrough Study Points to CARILLON(TM) Mitral Contour System(TM) as Exciting New Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation

KIRKLAND, Wash.--(HSMN NewsFeed)--The Society of Cardiovascular Angiography and Interventions (SCAI) will highlight Cardiac Dimensions(R), Inc.’s AMADEUS(TM) study during its 32nd annual scientific sessions held in Las Vegas, NV later this week. 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 and its secondary performance endpoints both at 6 months. The results are scheduled for presentation May 8th by Prof. Dr. med. Tomasz Siminiak from the Poznan University of Medical Sciences, Cardiac and Rehabilitation hospital in Poznan, Poland. Prof. Siminiak was the leading enroller in the AMADEUS(TM) study and has implanted more CARILLON(TM) implants than anyone in the world.

The CARILLON(TM) system is designed for percutaneous treatment of Functional Mitral Regurgitation (FMR). FMR results when the valve leaflets are pulled apart by the growing heart, and do not close properly. This leads to a significant reduction in the volume of oxygenated blood channeled from the heart to the rest of the body. Since 85 percent of heart failure patients experience heart enlargement, FMR is a common condition among these patients. FMR Patients are short of breath, fatigued, and experience a significant reduction in their quality of life as they become less and less mobile. The CARILLON(TM) system may offer a minimally invasive alternative to these patients who, up until now, have had limited treatment options. The CARILLON(TM) system is delivered via a catheter inserted through the jugular vein and guided into the heart. The implant is placed around the valve and is tightened in order to facilitate proper closing of the mitral valve leaflets.

“I have been extremely impressed with the safety, simplicity and performance of the CARILLON(TM) Mitral Contour System(TM),” stated Prof. Siminiak. “In my experience, many of my patients have benefited from this new therapy. I am pleased that SCAI has chosen to recognize AMADEUS(TM). The clinical results obtained have been very intriguing, which in turn create enthusiasm that this might become a true breakthrough treatment for a large group of patients who really have had no other option. My hope is that my colleagues who review the study results become interested in participating in further clinical and commercial use of this system.”

Founded in 1976, SCAI today boasts a membership of over 4,300 interventional cardiologists, with a charter of establishing standards and guidelines for all aspects of cardiac catheterization and angiography, training, safety and quality assurance for cardiac procedures. “We are delighted that a group with the history and ethical foundation of SCAI has chosen to highlight our AMADEUS(TM) study,” stated Rick Stewart, President and CEO of Cardiac Dimensions. “SCAI was the first organization to create uniform quality standards around catheter based therapies. We hold the SCAI charter in high regard and couldn’t be happier that they have selected our study as a significant effort.”

Approximately 5 million people in the U.S. and over 20 million people worldwide suffer from Heart Failure. Most of these patients also suffer from dilated cardiomyopathy and functional mitral regurgitation (FMR); the majority of whom 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. It is delivered percutaneously via jugular vein 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, thereby reducing mitral regurgitation. Preclinical and early clinical data have suggested both a reduction in mitral regurgitation and improvements in other key parameters including NYHA class, 6 Minute Walk distances, and Quality of Life.

Cardiac Dimensions(R), Inc., based in Kirkland, Washington, develops and manufactures devices designed for treating heart failure and related conditions.

For further information contact Tom Douthitt at (425) 605-5900 or visit Cardiac Dimensions(R), Inc. website at www.cardiacdimensions.com


Source: Cardiac Dimensions

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