Healthcare Industry News: Artificial Heart
News Release - August 27, 2013
Sunshine Heart Welcomes Dr. Patrick Verta as Chief Medical OfficerEDEN PRAIRIE, Minn., Aug. 27, 2013 -- (Healthcare Sales & Marketing Network) -- Sunshine Heart, Inc. (SSH) announced that, effective today, Patrick Verta, MD, has joined the Company as Chief Medical Officer. Dr. Verta brings over 20 years of experience in the medical field with the majority of time spent in the cardiovascular field.
Prior to joining Sunshine Heart, Dr. Verta served as Chief Medical Officer and Vice President of Clinical Affairs at Neomend, a medical device company that developed and commercialized the only FDA-approved sealant for air leaks following lung surgery via open thoracotomy. The company was acquired by Bard/Davol in October 2012. Before Neomend, he served as Medical Director of Clinical Research and Business Development at Abbott Vascular, where he played a critical role in the approval of several stent systems used in peripheral vascular disease, in particular carotid artery stenosis, renal artery stenosis, and peripheral Artery Disease (PAD). While at Abbott, Dr. Verta led the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the largest randomized carotid trial ever, enrolling over 2,500 patients and considered today to be the gold standard for carotid stenting trials. Prior to Abbott, Dr. Verta held the position of Endovascular Clinical Science and Biometrics Director at Guidant Corporation.
In addition to his experience driving clinical trials, he has co-authored seventeen manuscripts on novel medical device therapies in peer-review journals, and is credited with two patents in the data management and electronic data capture areas. Dr. Verta holds a Doctorate of Medicine from the Faculte de Medecine in Paris, France; as well as a Doctorate of Veterinary Medicine from the Ecole Nationale Veterinaire d'Alfort, France. He also completed a Masters Degree in Biostatistics at the University of Paris.
"We are pleased and fortunate to welcome Dr. Verta to Sunshine Heart as Chief Medical Officer," said Dave Rosa, Sunshine Heart's CEO. "His experience conducting large, complex clinical trials will be essential as we continue to progress within both our U.S. pivotal trial, COUNTER HF; as well as our European post-market study, OPTIONS HF. In particular, we look forward to his contributions toward accelerating and managing prudent site selection and enrollment with regard to both clinical trials going forward."
About the C-Pulse(R) 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 trial, 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 condition as a result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
About Sunshine(R) Heart
Sunshine Heart, Inc. (SSH) is a 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 trial 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 trial. 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.
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 trial activities and results including patient enrollment in trials. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical trials 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.
Source: Sunshine Heart
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