Cardiac Dimensions(R) Inc. Announces Completion of Enrollment in AMADEUS(TM) Trial with the CARILLON(TM) Mitral Contour System(TM).

30 Patient Safety & Efficacy Study in Europe is First with CARILLON[TM] Device

KIRKLAND, Wash. -- Cardiac Dimensions[R] Inc., a developer of devices to treat heart failure and related conditions, today announced that it has completed enrollment in the AMADEUS[TM] trial. AMADEUS[TM] (CArillon Mitral Annuloplasty Device European Union Study), a safety and efficacy study, is evaluating the CARILLON[TM] system at six centers across Europe. In June, Professor Tomasz Siminiak of the Poznan University of Medical Sciences Cardiac & Rehabilitation Hospital, implanted the final CARILLON[TM] devices while in Poznan, Poland. The study enrolled 30 patients and is designed to assess safety and performance at one, three, and six month endpoints.

AMADEUS[TM] principal investigator Professor Joachim Schofer from the Universitares Herz- und Gefabzentrum Hamburg GmbH, in Hamburg, Germany, stated, "Our initial experience in this study has gone a long way toward satisfying many questions we had about percutaneous annuloplasty using the Coronary Sinus approach, such as 'Will the coronary arteries be difficult to manage?,' 'Does the position of the CS relative to the mitral annulus limit efficacy?' and 'How frequently will patients experience clinical benefit?' While further studies are necessary to fully explore the capabilities of this device, our initial results are very encouraging and we are excited to move to the next phase with the CARILLON[TM] system."

"The CARILLON[TM] system is a promising investigational percutaneous therapy for Functional Mitral Regurgitation (FMR) and, even more broadly, heart failure patients," explained Professor Siminiak. "Most of my patients demonstrated at least a full NYHA Class reduction from baseline to 30 days. In addition, we were pleased with the ease of use and safety features, such as the 'recapture' feature that this device offers." He added, "I believe there is an incredible potential for application of this technology for many more patients."

"We are all tremendously excited to achieve this significant milestone in Europe with the CARILLON[TM] Mitral Contour System[TM]," stated Rick Stewart, President and CEO of Cardiac Dimensions. "The preliminary data we have received from the AMADEUS[TM] study is reflecting encouraging results along all key parameters. Our focus in Europe now is to complete our AMADEUS[TM] follow-up, while here in the U.S. we are working closely with the Food and Drug Administration (FDA) in an effort to gain IDE approval to continue the investigational process under our COMPETENT[TM] safety study."

Approximately five million people in the U.S. and over 20 million people worldwide suffer from Heart Failure. Most also suffer from dilated cardiomyopathy and functional mitral regurgitation (FMR). The 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 is 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 distal and proximal anchors on either end of a ribbon connector. 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 (CS/GCV) to reshape the annulus around the mitral valve, thereby reducing mitral regurgitation. Preclinical data has demonstrated both a reduction in MR and an improvement in Cardiac Output. The CARILLON[TM] Mitral Contour System[TM] is an investigational device both in Europe and the United States, where it is limited by Federal law to investigational use.

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 further information contact Tom Douthitt at 425 605-5900 or visit our Web site at www.cardiacdimensions.com.