As Director of the Center for Medical Devices (CMeD) at Mount Sinai Heart, Julie Swain, MD, offers her comprehensive knowledge of clinical trials for medical device technology and navigation of the regulatory approval processes. She simultaneously serves as Professor of Cardiovascular Surgery and Vice Chair of Clinical Performance, CV Surgery, for the Mount Sinai Health System. Her extensive experience in cardiac, vascular, and thoracic surgery are invaluable to the missions of the center as well as the Icahn School of Medicine at Mount Sinai.
Throughout her career, Dr. Swain has performed cardiovascular and vascular procedures, managing a university-based surgical practice in adult cardiac, thoracic, and vascular surgery, and intensive care unit medicine. She has designed and performed clinical research trials, led cardiovascular physiology basic science laboratories, and conducted collaborative research with US, European, Russian, Japanese, and Chinese scientists. Her published work includes studies in cardiovascular and pulmonary basic science, and translational clinical research. In addition, she has consulted with industry and membership on scientific advisory boards.
Dr. Swain has had many roles relating to cardiovascular devices, including those of Advisor to the U.S. Food and Drug Administration (FDA) for more than 20 years; Member and Chair of the FDA Cardiovascular Advisory Panel; Member of the FDA Urological and GI Devices Advisory Panel; Special Assistant to the Director, Division of Cardiovascular Devices, working with all of the Divisions in the FDA Center for Devices and Radiological Health/Office of Device Evaluation, as well as the Center for Biologics and the Center for Drugs; Collaborator with industry (U.S. and international), academics, and other government agencies in developing policy and in designing clinical study protocols, analyzing and interpreting data, and preparing advisory panel presentation. She also served as co-author of FDA Guidance on Clinical Trial Design.
She was the Lead Clinical Reviewer for transcatheter heart valve repair and replacement studies from the inception of the field and worked with companies to design studies, analyze data, and make regulatory recommendations. She held that same role for Mechanical Circulatory Assist devices from 2002-2009, developing performance goals for bridge-to-transplant, working with companies to design studies, analyzing the data, and making FDA regulatory recommendations. Dr. Swain also served as Lead Clinical Reviewer for medical devices for the fields of heart failure, myocardial ischemia treatment, left atrial appendage closure, atrial septal defects, embolic protection, extracorporeal membrane oxygenation, therapeutic hypothermia, and cardiopulmonary resuscitation. She designed clinical trials for vascular grafts, neurological devices, stroke studies, atrial fibrillation, vascular stents, pressure monitors, organ preservation, and pulmonary devices for treating emphysema.
Of particular interest to Dr. Swain are the neurological effects of cardiovascular devices, along with studies for stroke, TIA, and migraine. She advised FDA management on new trends in medical device development and use, and worked closely with Centers for Medicare and Medicaid Services on reimbursement issues for medical devices. Developing trial design, endpoint, and adverse event definitions for transcatheter valves, Dr. Swain served as an FDA representative on the Valve Academic Research Consortium and the Mitral Valve Academic Research Consortium. She has also served as a member of the Scientific Advisory and Data Safety Monitoring Boards.
Dr. Swain has worked closely with engineers and veterinarians, collaborating on preclinical study issues. She has also joined forces with statisticians to design and interpret clinical trials, and with FDA epidemiologists to develop and conduct post-market studies.