Patients Implanted With the C-Pulse Heart Assist System Demonstrated Statistically Significant Improvement Based on New York Heart Association Class Reduction, Quality of Life and Left Ventricular Ejection Fraction

SYDNEY, AUSTRALIA and EDEN PRAIRIE, MN -- Sunshine Heart, Inc., a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced the results of the approved U.S. Food and Drug Administration (FDA) feasibility clinical trial with the C-Pulse System.

"The completion of the C-Pulse Heart Assist System feasibility trial demonstrates that C-Pulse has the potential to help the millions of moderate to severe heart failure patients who have limited, if any, therapeutic interventions available to them," said Dave Rosa, CEO of Sunshine Heart. "With this important milestone behind us, we will look to work with the FDA to gain permission to initiate a pivotal trial in the U.S. next year."

At eight North American sites (n=20), 18 patients with ACC/AHA Stage C, New York Heart Association (NYHA) Class III heart failure and two patients with ambulatory Class IV heart failure on optimal medical management were implanted with the C-Pulse Heart Assist System. After six months follow-up, C-Pulse therapy produced statistically significant improvements in NYHA Class reduction (3.1+/-0.3 to 2.2+/-0.8, P=0.0001), Quality of Life (64+/-17 to 49+/-26, P=0.001), and Left Ventricular Ejection Fraction (28+/-5 to 31+/-7, P=0.04) which measures the heart's pumping ability.

All but one patient remained unchanged or demonstrated improvement in NYHA, Minnesota Living With Heart Failure (MLWHF) quality of life and Six Minute Hall Walk (6MHW). In addition, four patients improved to NYHA Class I and two patients were permanently removed from therapy due to improvements.

Primary safety measurements included device related death, neurological dysfunction (strokes), aortic disruption, myocardial infarction (heart attack), major infection and any other device-related serious adverse event through six months. One patient died from complications of mediastinitis which was related to a sternal wound infection resulting from the sternotomy at implant. There were no strokes, heart attacks or device related bleeding events.

National co-lead principal investigator, William T. Abraham, M.D., director of the division of cardiovascular medicine at Ohio State University Medical Center, will present these results at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco on Monday, November 7, 2011, 7:15 - 7:29 p.m. (PST), Room 121.

"Despite current drug and device therapies, thirty to forty percent of heart failure patients exhibit poor functional status and quality of life," commented Dr. Abraham. "The results of the C-Pulse Heart Assist System feasibility trial support the preliminary assessment of safety and efficacy of the device. A prospective multi-center trial to further assess the safety and efficacy of C-Pulse is warranted."

About the C-Pulse(R) Heart Assist System The C-Pulse Heart Assist System, an investigational device, utilizes the proven scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Operating outside the patient's bloodstream, the novel extra-aortic approach of the C-Pulse technology offers greater flexibility allowing patients to disconnect as necessary or desired. The C-Pulse system's potential benefits may help reverse the heart failure process or maintain the patient's current condition, which may reduce the need for later stage heart failure therapies, such as left ventricular assist devices (LVADs), artificial hearts or transplants.

Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.

SOURCE: Sunshine Heart, Inc., Marketwire via Comtex