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Dr. Francis Duhay, a trained cardiac and thoracic surgeon, is the former Chief Medical Officer at Edwards Life Sciences, the world’s leader in heart valves, where he led medical and clinical affairs for transcatheter and surgical heart valves. While at Edwards, Dr. Duhay led the preparation and submission, and ultimate regulatory approval of two FDA Premarket Approval (PMA) applications for transcatheter and surgical heart valve therapies and was responsible for the design and execution of the applicable clinical trials. Dr. Duhay was also the Vice President and General Manager of the Ascendra™ transcatheter heart valve business unit at Edwards, where he grew the unit from sixteen to eighty employees and contributed to annual growth in sales from $3 million to $250 million. Dr. Duhay was also an industry representative and clinical expert, and member of the working group for ISO 5840, the international quality standard for the design, development, and testing of heart valves.