First Patients in United States Receive Innovative Device to Treat Moderate Hea...( The Ohio State University Medical C...),Health

The Ohio State University Medical Center Implants Two Patients with Sunshine Heart's C-Pulse(TM) Heart Assist System Under FDA-Approved Clinical Trial

SYDNEY, and TUSTIN, Calif., April 21 /PRNewswire/ -- Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, announced today that The Ohio State University Medical Center in Columbus, Ohio has successfully completed the first two implants of the Company's C-Pulse(TM) heart assist system under a 20 person clinical trial approved by the U.S. Food and Drug Administration (FDA).

These C-Pulse systems were implanted by Dr. Benjamin Sun, Chief, Division of Cardiothoracic Surgery and Director, Cardiac Transplantation and Mechanical Support.

"It is an honor to have completed the first U.S. implants of the C-Pulse heart assist system," said Dr. Sun. "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 moderate heart failure."

"We are excited that our clinical trial in the U.S. has started so successfully," said Dr. William Peters, Medical Director of Sunshine Heart and the inventor of C-Pulse. "We have demonstrated in prior clinical studies that the C-Pulse system increases blood flow to the body and to the heart muscle itself. We anticipate that C-Pulse will offer patients a significant improvement in quality of life." Dr. Peters went on to point out importantly that the device operates without coming into direct contact with the blood, so avoiding potential complications with systems that do contact blood. A feature of the design of the C-Pulse is that patients can safely disconnect from the device for short periods for their convenience."

"The completion of the initial C-Pulse implants in the U.S. is a major milestone for Su
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