EDEN PRAIRIE, Minn., Sept. 11, 2014 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) announced today that its flagship C-Pulse® Heart Assist System will be featured in a clinical presentation at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The TCT symposium will take place September 13th-17th in Washington, DC at the Walter E. Washington Convention Center.
On Tuesday, September 16th, there will be an oral presentation as part of the day's session entitled, "Myocardial Recovery in Ambulatory Heart Failure Patients Treated with the C-Pulse Cardiac Assist System: A Single-Center Experience." The oral presentation will be included in Session II: Mechanical Circulatory Support for Chronic CHF at 4:48 p.m. (EDT) in Level 1, Room 152A/B. The oral presentation will be led by Dr. Sanjeev Aggarwal, MD, Director of Mechanical Circulatory Support at Saint Luke's Mid America Heart Institute.
In addition, the Company will host an analyst and investor breakfast on Tuesday, September 16th at 7:00 a.m. (EDT) held at the Grand Hyatt Washington. Management will provide a brief corporate update followed by physician presentations listed below:
- Dr. Sanjeev Aggarwal, Mid America Heart Institute - Single Center Experience with Patient Weaning from the US Feasibility Trial and thoughts from a leading enroller in the COUNTER HF™ US Pivotal Study
- Christopher Bowles, PhD, Royal Brompton and Harefield NHS Foundation Trust & Imperial College London - OPTIONS HF Post Market Multicenter Trial: Early Experience in Europe: a case study Harefield Hospital UK
- Dr. William E. Cohn, Texas Heart Institute - Progress of Fully Implantable Pump
The program will conclude with a question and answer session.
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 be weaned from using the device due to sustained improvement in their heart failure condition 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 a wholly owned subsidiary in Australia. 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, 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 SEC. 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.