CARILLION MITRAL CONTOUR SYSTEM IMPLANTED FOR AMADEUS.

Cardiac Dimensions(R), Inc. has announced the first human implant of the CARILLON(TM) Mitral Contour System(TM), an investigational device for percutaneous treatment of Functional Mitral Regurgitation (FMR). The procedure was performed in Hamburg Germany by Professor Dr. med. Joachim Schofer -- the principal investigator (PI) of the company's AMADEUS(TM) trial. AMADEUS (cArillon Mitral Annuloplasty Device European Union Study) is a safety and efficacy study of the CARILLON system ongoing at seven centers across Europe. The study will enroll 30 patients, and assess safety and efficacy at 1, 3 and 6 month intervals. "The first patient, a 62 year-old male, presented several challenges. The MR grade was significant, and due to the magnitude of coronary artery disease that was present, we were concerned that our ability to effectively treat MR would be limited," explained Professor Schofer. "The patient had been in the hospital for several weeks prior to the procedure. After we implanted the CARILLON device, the treated MR was reduced to trace, and the next day we moved the patient out of the ICU. In fact, he indicated that he felt much better and wanted to go home."

"At our institution, there was a great deal of interest in the CARILLON device and, as a result, we had many physicians in attendance at this case -- including the heads of Cardiology and Cardiac Surgery from the University of Hamburg's Eppendorf Uni-Klinikum," continued Professor Schofer. "All of us were impressed with the ease of placement and the effectiveness of the device."

Chief of Cardiac Surgery at the University Clinic Hamburg -- Professor Dr. med. Hermann Reichenspurner, Ph.D., added, "The CARILLON is an interesting and promising device that can achieve equivalent results to those expected from the placement of a surgical annuloplasty device in selected cases. I am very impressed with the results and see a tremendous opportunity for many more patients. It requires a close cooperation between cardiologist and cardiovascular surgeon, which we have here with Professor Schofer and his colleagues."

"We realize that this is just the beginning of the trial and we have a lot of work still in front of us," stated Rick Stewart, president and CEO of Cardiac Dimensions. "At the same time, we are all tremendously excited by our initial experience with the CARILLON Mitral Contour System in a very challenging patient."

Cardiac Dimensions Chief Medical Officer, Dr. David Reuter, presented an overview of the technology and the first case at the "Summer In Seattle" conference this week. Approximately 5 million people in the U.S. and over 20 million people worldwide suffer from 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 burden of the surgery itself, which is 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 (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(R) 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 Frazier Healthcare Ventures.

For more information call 425/605-5900 or visit http://www.cardiacdimensions.com.