EDEN PRAIRIE, Minn., Oct. 7, 2014 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced the results of its feasibility study entitled "Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Severe Chronic Heart Failure," published in the Journal of American College of Cardiology Heart Failure (JACC HF). The study showed that the use of the C-Pulse System in Class III and ambulatory Class IV heart failure (HF) patients is feasible while providing preliminary indications of safety and improvements in functional status and health-related quality of life (QOL).
William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center, said, "There are numerous challenges with the current treatment options of Class III and ambulatory Class IV heart failure patients. Surgical treatments available are often last resort, high risk and invasive. The C-Pulse System addresses these challenges, is less invasive, has a lower risk profile and can be placed in patients too sick to be on optimal medical therapy alone, but not so sick that they require mechanical circulatory support or a heart transplant."
The C-Pulse System feasibility study was a prospective, open-label, single-arm 20-patient study approved by the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) and undertaken at seven centers in North America. Following baseline testing, eligible patients who had New York Heart Association (NYHA) Class III or ambulatory Class IV HF underwent implantation of the C-Pulse System between April 15, 2009 and June 20, 2011. No anti-coagulants were required with use of the C-Pulse System, reducing the risk of bleeding complications; and the location of the implanted cuff around the aorta mitigated the risk of intra-vascular clotting concerns.
At 6 months, C-Pulse produced statistically significant improvements in NYHA Class (3.1 to 1.9, p=0.0005), as well as in two validated QOL instruments including the Minnesota Living with Heart Failure questionnaire (63.6 to 40.2, p=0.0005) and the Kansas City Cardiomyopathy Questionnaire (43.6 to 65.6, p=0.0002). The 6 Minute Walk Distance improved at 6 months with statistically significant improvement at one year (289.7 to 336.5, p=0.0425). There was no change in peak VO2 (14.5 to 13.1, p=0.2612). Importantly, over the 12 months following initial placement of the C-Pulse device, only 3 of the 20 implanted patients (15%) had 5 adjudicated heart failure related hospitalizations, none which occurred within 30 days of implant.
There were no 30-day operative deaths reported in the study. Additionally, there were no neurological events, no device related bleeding events, no stroke events, and no myocardial infarctions through 12 months. At 12 months, there was one adjudicated device-related death. The device-related death was attributed to complications arising from a sternal wound infection in a patient who underwent repeated sternotomies and attempted sternectomy. Exit-site infections were also observed in 8 patients which prompted the Company to incorporate changes to mitigate this in the future.
Dr. Abraham added, "Although the study was not designed or powered to demonstrate efficacy, the magnitude of patient improvements using the C-Pulse System is clinically meaningful when compared to prior drug and device studies in heart failure. In addition, there were patients that were successfully weaned from the device, an early indication that C-Pulse may have reversed or prevented the progression of their disease, preventing the need for an LVAD or a heart transplant."
Based on review of the feasibility study data, a prospective, randomized, controlled study designed to demonstrate and extend these observations was approved by the FDA in November 2012 (COUNTER HF™). With stricter guidelines for exit site management and use of a minimally-invasive implant procedure, this pivotal study is currently underway in the U.S.
"The promising results of the feasibility study suggest that the C-Pulse System may lead to improvements in the quality of life of patients suffering from Class III and ambulatory Class IV heart failure and demonstrate that the C-Pulse system may offer an advantage over other treatment options," said David Rosa, Chief Executive Officer of Sunshine Heart. "We continue to advance our COUNTER HF™ U.S. pivotal study and our European OPTIONS HF study."
Clips to Interview with William Abraham, M.D.:
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Challenges with current treatments of Class III and ambulatory Class IV heart failure patients:
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The potential solution the C-Pulse System may provide for the treatment of Class III and ambulatory Class IV heart failure patients:
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Advantages of C-Pulse System of other treatments of heart failure:
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Discussion on results of the feasibility study:
Other Relevant Videos:
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.