08.28.13
Patrick Verda, M.D. has joined Eden Prairie, Minn.-based Sunshine Heart Inc. as its new chief medical officer (CMO). Verta brings 20 years of experience in the medical field, the majority of which was spent in the cardiovascular space.
Prior to joining Sunshine Heart, Verta served as CMO 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. While at Abbott, 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, he 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 medical device therapies in peer-review journals, and is credited with two patents in the data management and electronic data capture areas. Verta holds a doctorate of medicine from the Faculté de Médecine in Paris, France; as well as a doctorate of veterinary medicine from the École Nationale Vétérinaire d'Alfort, France. He also completed a master’s 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.”
The COUNTER HF trial is a randomized study evaluating Sunhine Heart’s C-Pulse therapy in NYHA (New York Heart Association) Class III and ambulatory Class IV patients by measuring freedom from worsening heart failure resulting in hospitalization, LVAD (left ventricular assist device) implantation, cardiac transplantation or death as compared to optimal medical treatment. The OPTIONS HF is the post-market study for the same device in Europe.
C-Pulse, which is an investigational device in the United Sates, uses the principles of an 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.
Prior to joining Sunshine Heart, Verta served as CMO 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. While at Abbott, 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, he 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 medical device therapies in peer-review journals, and is credited with two patents in the data management and electronic data capture areas. Verta holds a doctorate of medicine from the Faculté de Médecine in Paris, France; as well as a doctorate of veterinary medicine from the École Nationale Vétérinaire d'Alfort, France. He also completed a master’s 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.”
The COUNTER HF trial is a randomized study evaluating Sunhine Heart’s C-Pulse therapy in NYHA (New York Heart Association) Class III and ambulatory Class IV patients by measuring freedom from worsening heart failure resulting in hospitalization, LVAD (left ventricular assist device) implantation, cardiac transplantation or death as compared to optimal medical treatment. The OPTIONS HF is the post-market study for the same device in Europe.
C-Pulse, which is an investigational device in the United Sates, uses the principles of an 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.