EDEN PRAIRIE, Minn., Dec. 1, 2014 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) announced today that the Company's initial Austrian site for the OPTIONS-HF study has implanted its first patient with the C-Pulse System for moderate to severe heart failure. Prof. Dr. Herwig Antretter of the University of Innsbruck performed the operation, which took place on November 11th, 2014. A 92 minute surgical implantation procedure was successfully completed and the patient was discharged from the hospital 7 days post-surgery. This milestone marks the eleventh implantation of the C-Pulse System across fourteen activated EU centers participating in the OPTIONS HF post-market surveillance clinical study.
"The C-pulse system is an ideal addition for patients in the treatment of NYHA III and ambulatory IV stage heart failure," said Prof. Dr. Antretter. "It is easy to implant the device, doesn´t need a heart lung machine, and allows for quick patient recovery. Our patient was extubated in the operating room, stayed just a couple of hours in the ICU, and was then transferred to a normal ward. We discharged him after only one week."
The patient was selected in cooperation with Univ.-Doz. Dr. Gerhard Poelzl, F.E.S.C. a leading Heart Failure Cardiologist (department of Univ. Prof. Wolfgang-M. Franz, Internal Medicine III, Cardiology and Angiology) in the University Hospital of Innsbruck. The patient suffers from dilated cardiomyopathy with severe impairment of his left ventricle, low ejection fraction (EF < 25%) and has survived an extensive cardiopulmonary resuscitation due to sudden cardiac arrest in January 2014 without any neurological deficit. Despite his advanced age and his medical history, the patient remains highly active and employed.
"I'm extremely pleased that we have introduced the C-Pulse therapy to yet another key country. As discussed in our Q3 quarterly update, we continue to remain enthusiastic regarding the increased overall momentum for the OPTIONS HF study," commented Dave Rosa, Sunshine Heart Inc. Chief Executive Officer.
The OPTIONS HF study is a post-market, multi-center, prospective, open label study that will include 50 patients in up to 15 European centers. The study is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system. The primary endpoint is comparable to the COUNTER HF trial as it evaluates the rate of re-hospitalization due to worsening heart failure and heart failure related death in addition to many other traditional heart failure endpoints.
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 counterpulsation 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 will 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.
About Sunshine® Heart
Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical study of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application. Sunshine Heart received unconditional approval from the FDA in November 2012 to initiate its pivotal study. In July 2012, Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.
Forward-Looking Statements
Certain statements in this release are forward-looking statements that are based on management's beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including, without limitation, our expectations with respect to future clinical study activities and results including patient enrollment in studies. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility that we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the EU and the other risk factors described under the caption "Risk Factors" and elsewhere in our filings with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.