Prominent Heart Failure Docs to Lead Heart Assist Device Trial


February 23, 2007

Feb. 23, 2007 — Dr. William T Abraham of Ohio State University, Columbus, Ohio and Dr. Patrick M McCarthy of Northwestern University, Chicago, Illinois, have agreed to become the Co-Principal Investigators for C-Pulse Feasibility Trial in the U.S. Australia-based Sunshine Heart, a global medical device company, says it is committed to the commercialization of the C-Pulse, an implantable, non-blood contacting, mechanical heart assist device for the treatment of people with heart failure.

The appointment continues Sunshine Heart's progress towards commencing the multicenter U.S. Feasibility Trial during 2007 following the positive meeting with the FDA that was announced on 22 December 2006.

William T Abraham, M.D. FACP, FACC, FAHA is Professor of Internal Medicine, Division Director of Cardiovascular Medicine and Deputy Director of the Davis Heart and Lung Research Institute at Ohio State University. He has participated in more than 100 drug and device clinical trials and has been International Principal or Co-Principal Investigator for several of Medtronic's heart failure pacemaker trials (Miracle, Miracle ICD).

"The C-Pulse has great potential in the treatment of patients with moderately severe heart failure," said Dr. Abraham.

Patrick M McCarthy, M.D. is the Heller-Sacks Professor of Surgery, Division Chief of Cardiothoracic Surgery and Co-Director of the Bluhm Cardiovascular Institute of the Northwestern University Feinberg School of Medicine. Dr. McCarthy has been recognized as an innovative and leading cardiovascular surgeon and researcher. He has been a clinical investigator in trials of several heart assist devices and is Chairman of the Society of Thoracic Surgeons/American Association for Thoracic Surgery Joint Working Group on New Technology.

Dr. McCarthy recently presented the C-Pulse(TM) at University's Heart Failure Summit, in "The Future of Congestive Heart Failure" Session.

The C-Pulse is an implantable, non-blood contacting mechanical heart assist device designed to provide long term support for people with moderate to severe (Class III) heart failure. The device is designed to be implanted without the need for bypass and does not contact the bloodstream, reducing the risk of bleeding and blood clot formation.

The C-Pulse Cuff consists of a wrap and a balloon which is placed around the aorta just above the heart. The balloon is inflated and deflated to the rhythm of the heart to improve blood supply to both the body and the heart muscle, while reducing the workload on the heart.

The C-Pulse Driver is an external wearable unit that is linked by an air tube to the cuff and detects the heart's natural rhythm and controls inflation and deflation of the balloon in rhythm with the heart.

Implantation of the C-Pulse involves wrapping the cuff around the aorta. No incisions into the aorta are needed so that the device never comes into contact with the patient's bloodstream. The C-Pulse(TM) balloon inside the cuff is designed to inflate in a way that rolls the wall of the aorta inward in a gentle 'thumb printing' manner. The balloon is inflated and deflated rhythmically to improve blood supply to the heart and body as well as reduce the workload of the heart.

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