News & Events

The female patient was implanted under the Company’s existing feasibility trial approved by the US Food and Drug Administration and represents the ninth patient implanted overall and fourth within the past five weeks. The procedure was performed successfully by Dr Mark Slaughter of Louisville Hospital. Dr Slaughter is a widely recognised expert in the area of heart assist technologies.

Dave Rosa, CEO of Sunshine Heart, commented, "The Company achieved an important milestone today. This implant procedure represents the next step in our overall goal to provide a minimally invasive therapy for Class III/IVa heart failure patients. We believe this procedure offers less procedural risk than other approved heart failure technologies and will make it more attractive for patients and physicians to choose our therapy."

Dr Slaughter commented, "The C-pulse system is ideal for a minimally invasive approach. Combined with the fact it has no blood contacting surfaces it provides a good alternative for patients with advanced heart failure."

Commenting on other developments, Mr Rosa said, "We believe we are now beyond the early challenges usually encountered in enrolling the early patients for a trial. While there is still more work to be done, we are certainly pleased with the recent increase in the pace of enrolments as the results from the first patients come through. We have recently added several new centers and we expect they will start enrolling in the near term." Mr Rosa also noted that, as enrollment becomes more consistent, the Company will provide future updates when appropriate as opposed to announcing each implant individually.

Sunshine Heart (ASX: SHC) (www.sunshineheart.com) is a global medical device company committed to the commercialization of C-Pulse® a minimally invasive implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure. C-Pulse reduces the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart’s pumping load. The Company has received approval from the US Food and Drug Administration (FDA) to conduct a 20 person US clinical trial with C-Pulse and patient enrolment has commenced. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.