Sunshine Heart Initiates Animal Study on Applicability of C-Pulse Technology in the Treatment of Pulmonary Arterial Hypertension

EDEN PRAIRIE, Minn., (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) announced today the commencement of a collaborative effort with Dr. Mark Slaughter and the University of Louisville to study the impact of the C-Pulse technology on the pulmonary circulation and right heart, specifically in the field of pulmonary hypertension and heart failure.

Pulmonary arterial hypertension (PAH) is a debilitating condition characterized by progressive increases in pulmonary vascular resistance and loss of elasticity of the pulmonary artery and large vessels. Patients with PAH suffer from poor quality of life, shortness of breath and greatly reduced functional capacity leading to right ventricular dysfunction and ultimately, right heart failure. PAH afflicts approximately 200,000 patients worldwide and places a significant burden on the healthcare system, with limited treatment options available and 5 year survival rates as low as 34%¹. PAH and right heart failure are also commonly associated with left heart failure. Approximately 50% of patients with systolic heart failure or preserved ejection fraction heart failure (HFpEF) have PAH with similar 5 year outcomes². PAH and right heart failure also continue to remain a significant risk in the left ventricular assist device patient population³.These studies hope to provide scientific rationale for a new application of current C-Pulse therapy by leveraging the existing technology to apply counterpulsation to the pulmonary artery in acute and chronic animal preparations. Biochemical, neurohormonal and pressure-volume data will be used to assess the effects of C-Pulse on pulmonary circulation and right and left heart properties. A fully implantable system may provide therapeutic options in HFpEF population with PAH where there are currently no approved treatments.

About the C-Pulse® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the 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. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

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

1. D’Alonzo, GE et al. Ann Int Med 115: 342-349, 1991
2. Miller WL et al. JACC HF 1(4): 290-299, 2013; Guazzi M. Circ. Heart Fail. 7: 367-377, 2014
3. MacGowan, GA and Schueler, S. Curr Opin Cardiol 27(3); 296-300. 2012