Cardiac Dimensions(R) Inc. Announces U.S. IDE Approval to Initiate the COMPETENT(TM) Pilot Study of the CARILLON(TM) Mitral Contour System(TM) for Treatment of Functional Mitral Regurgitation.

KIRKLAND, Wash. -- Study Approval Will Initiate the Evaluation of a "First-of-Its-Kind" Percutaneous Coronary Sinus-Based Treatment Approach

Cardiac Dimensions(R) Inc. announced today that the Food and Drug Administration (FDA) has recently granted the company Investigational Device Exemption (IDE) approval to initiate its COMPETENT(TM) Pilot study of the CARILLON(TM) Mitral Contour System(TM) for treatment of mitral insufficiency in patients suffering from Heart Failure. This insufficiency is a result of a progression of disease called Functional Mitral Regurgitation (FMR), which afflicts between 50-60% of all heart failure patients. The presence of FMR in a heart failure patient contributes to higher morbidity and mortality rates, and neither medical nor surgical treatment options are optimal. The CARILLON Mitral Contour System represents the first percutaneous coronary sinus (venous) based treatment approach to be evaluated in the United States under an IDE approved study.

The company plans to conduct the COMPETENT trial at eight centers throughout the United States. Cardiac Dimensions is also sponsoring a parallel safety study at seven centers in Europe called AMADEUS(TM). This trial recently received ethics committee approvals in Europe and has already begun enrolling patients at several centers in Europe.

"IDE approval represents a significant milestone for our company and our efforts to advance this important developing therapy," stated Rick Stewart, President and CEO of Cardiac Dimensions. "The CARILLON system has the potential to help millions of patients suffering from heart failure and FMR. Following very successful results in the pre-clinical setting, we are anxious to move our activities into the clinical environment in both COMPETENT and AMADEUS trials."

Prior to IDE approval, the CARILLON Mitral Contour System has undergone extensive pre-clinical evaluation, and features of the device have been tested in a small "acute" trial in Australia. "In our acute study, the results were exceptional," stated David Kaye, MD, of the Alfred Hospital in Melbourne. "The product performed just as expected. It was easy to position, easy to deploy, and at the end of the procedure, we were able to successfully recapture the implant. The team here is very excited about the potential of this new technology," commented Dr. Kaye.

Approximately 5 million people in the U.S. and over 20 million people worldwide suffer from Congestive Heart Failure. The majority of those suffer from dilated cardiomyopathy and functional mitral regurgitation. While surgical options exist and can be effective in reducing FMR, they are infrequently used due to the trauma of the surgery itself, which is associated with high operative morbidity and mortality rates. "Functional MR represents a significant issue for an aging population here in the U.S. and worldwide," said Campbell Rogers, MD, of Brigham & Women's hospital in Boston, the principal investigator (PI) for the COMPETENT study. "Currently there are no approved effective percutaneous approaches for treating these patients. The CARILLON system is intuitive and easy to use. We are excited to be able to participate in such an important study in such a novel therapeutic area."

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 (GCV) to reshape the annulus around the mitral valve to reduce mitral regurgitation. Preclinical data has demonstrated both a reduction in MR and an improvement in Cardiac Output.

Cardiac Dimensions Inc. is based in Kirkland, WA, and develops and manufactures devices designed for treating heart failure and related conditions. It is a privately held company whose investors include MPM Capital, Interwest Partners, Polaris, and Frasier Health Care.