EDEN PRAIRIE, Minn., Aug. 19, 2014 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced that the current condition of a heart failure patient implanted with the C-Pulse® System improved after six weeks of treatment, allowing him to attend his daughter's wedding. The patient, Ross Swift, a 54 year-old grandfather from Devon, U.K., received C-Pulse at Harefield Hospital in London and is participating in the OPTIONS HF study, a post-market surveillance study being conducted in countries in Western Europe. C-Pulse system received the CE Mark in 2012. The story was reported in an article published today in The Daily Mail, titled, Me and My Operation: Pump that squeezes your arteries to help fight heart failure. The surgical procedure was carried out by André Simon, M.D., director of transplantation at Royal Brompton & Harefield NHS Foundation Trust
"When I received the C-Pulse System, immediately I could tell there was a difference. When I breathed, it felt clearer. I had more color in my face and my family said my attitude changed," said Mr. Swift. "I feel more positive. I find day-to-day activities, which used to wear me out, much easier to get on with and recover from afterwards.
"The wedding was amazing. Everybody was crying knowing what we had been through. Walking my daughter down the aisle was something a few months ago we didn't believe was possible."
The C-Pulse System's design is based on an extra-aortic balloon cuff counter-pulsation therapy that is applied outside of the bloodstream and assists the heart by reducing the workload of the left ventricle. During inflation of the balloon cuff, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation of the balloon cuff, the workload or pumping required by the left ventricle is reduced. The balloon's inflation and deflation is synchronized to the patient's heart rhythm, similar to a pacemaker.
"The C-Pulse System is a treatment option that has not previously been available for this particular group of heart failure patients," said Dr. Simon "The aim of implanting the system is to help slow the deterioration of a failing heart, which can relieve heart failure symptoms and improve their quality of life. At Harefield Hospital we see lots of patients with heart failure who are limited in their everyday activities, such as walking to the shops or taking part in family activities, but many of these patients are not sick enough to need a heart transplant."
Sunshine Heart is currently enrolling patients in clinical studies in the U.S. and Europe for treatment of moderate to severe heart failure. The OPTIONS HF clinical study is a post-market, multi-center, prospective, surveillance study in up to fifteen European centers. The study is designed to observe long-term clinical outcomes of heart failure patients treated with the C-Pulse System. Concurrently, the company's COUNTER HF™ US pivotal study is underway and designed to achieve commercial approval of the C-Pulse System in the United States.
More information regarding the US COUNTER™ HF clinical study can be found at: http://hfclinicalstudy.com/index.htm
More information regarding the European OPTIONS HF clinical study can be found at: http://clinicaltrials.gov/ct2/show/NCT01872949?term=NCT01872949&rank=1
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.