Cardiac Dimensions(R) Inc. Announces First Implant Of CARILLON(TM) Device In Its TITAN(TM) Study

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 14 May 2008 - 3:00 PDT

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Cardiac Dimensions®, Inc. announced the first implant of the CARILLON™ Mitral Contour System™ as part of its new TITAN™ study. The procedure was performed in Neuss Germany by Professor Dr. med. Michael Haude. TITAN™ is the latest clinical effort initiated by Cardiac Dimensions®. The study, which will be conducted in 6 centers across Europe and enroll up to 50 patients, will assess safety and efficacy at 1, 6, 12, 18, and 24 months, then annually at 3, 4, and 5 years.

The CARILLON™ system is a percutaneous treatment of functional mitral regurgitation (FMR), currently under investigational use in Europe, South America, and Australia only.

"The first patient, a 57 year-old male, presented with MR grade 3 and NYHA class III. The procedure went very smoothly and we were quite satisfied with the result," explained Professor Haude. "The patient had been in the hospital for several weeks prior to the procedure and is now doing very well."

Professor Haude is the Chief of Cardiology at the Stadtische Kliniken Neuss in Neuss, Germany and previously participated in the company's AMADEUS™ study. "In my experience with the device, the CARILLON™ holds a great deal of promise for patients with functional mitral regurgitation. It has provided clinical benefit to those patients in whom I have placed it, and I see a tremendous opportunity for many more patients."

"We are extremely excited about getting the TITAN™ trial started," commented Rick Stewart, President and CEO of Cardiac Dimensions. "The CARILLON™ system has met all our expectations to date, and we are very pleased to kick-off the TITAN™ trial in such a strong manner. It is a testimony to the work of a very talented team here at Cardiac Dimensions®, and our collaboration with an impressive group of investigators."

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™ Mitral Contour System™ 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.

Cardiac Dimensions®, Inc., based in Kirkland, WA, 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®, Inc. website at http://www.cardiacdimensions.com.Cardiac Dimensions