News & Events

Sunshine Heart, Inc. (ASX: SHC), a global medical device company focused on innovative technologies for advanced heart failure, announced today that Jewish Hospital in Louisville, Kentucky has completed implants of the Company's C- PulseTM heart assist system in two female patients, ages fifty-eight and fifty-five, respectively, under a clinical trial approved by the US Food and Drug
Administration (FDA). These procedures mark the first US female patients and the third and fourth patients treated with the C-Pulse heart assist system.

The C-Pulse system was implanted by Dr Mark Slaughter, Professor of Surgery and Chief of the Division of Thoracic and Cardiovascular Surgery at the University of Louisville. Dr Slaughter is a renowned cardiothoracic surgeon who also serves as the Director of the Heart Transplant and Mechanical Assist Device program at Jewish Hospital and the University of Louisville and is the Associate Medical Director of the Cardiovascular Innovation Institute.

"It is an honour to have completed the first US implants of the C-Pulse heart assist system in female heart failure patients," said Dr Slaughter. "C-Pulse is highly innovative and implanted with a simple, low-risk minimally invasive surgical procedure. The device has the potential to offer a new therapy option for the treatment of advanced heart failure."

"We are excited to be a part of the C-Pulse clinical trial in the US," said Dr Sumanth Prabhu, Professor of Medicine and Physiology and Director of Heart Failure at the University of Louisville and Co-Principal Investigator of the trial at Jewish Hospital. "The C-Pulse system is a novel device that increases blood flow to the body and to the heart muscle itself without coming into direct contact with the blood. Consequently, the risk of stroke and embolism appears to be negligible and blood thinning medication is not required."

Dr Prabhu is a recognized clinician and scientist whose research centers on understanding mechanisms underlying heart failure. He is especially interested in defining potential therapies geared toward myocardial recovery in heart failure.

"Enrolling the first two female patients into this FDA approved clinical study is a significant milestone for C-Pulse. Despite the fact that females account for nearly 50% of all hospital admissions for heart failure (heart failure affects about 2.5 million women in the US), only 25% of these patients are typically involved in heart failure studies," said Don Rohrbaugh, CEO. "C-Pulse can be an important new therapy for women suffering from heart failure since they typically survive longer than men with the disease but commonly have more illness, more frequent hospitalizations and a poorer overall quality of life."

The 20 patient FDA-approved feasibility clinical trial is being undertaken at six US medical institutions: Northwestern Memorial Hospital, The Ohio State Medical Center, Jewish Hospital, Hershey Medical Center of the Pennsylvania State University, University of Florida School of Medicine and University of Alabama/ Birmingham Medical Center.