Meet the Director
Julie Swain, MD, is the Director of the Center for Medical Devices (CMeD) at Mount Sinai Heart. In addition, she serves as Professor of Cardiothoracic Surgery and Director of Clinical Research in the Department of Cardiothoracic Surgery at the Icahn School of Medicine at Mount Sinai. Dr. Swain brings to Mount Sinai and CMeD her vast expertise and knowledge of the testing of the latest medical device technology in clinical trials and regulatory approval processes as well as her clinical experience in cardiac, vascular and thoracic surgery. Dr. Swain's in-depth career experience includes:
Expertise in Clinical Trial Design and Regulatory Experience
- Academic cardiothoracic and vascular surgeon for more than 21 years.
- University-based surgical practice in adult cardiac, thoracic, vascular surgery and intensive care unit medicine.
- Designed and conducted clinical research trials.
- Led cardiovascular physiology basic science laboratories.
- Collaborative research with US, European, Russia, Japanese, and Chinese scientists.
- Publications in cardiovascular and pulmonary basic science and translational clinical research.
- Consulted with industry and membership on Scientific Advisory Boards.
Long-Term Advisor to US Food and Drug Administration (FDA)
- Served as advisor to FDA for more than 20 years.
- Member and Chair of FDA Cardiovascular Advisory Panel (8 years), also served on FDA Urological and GI Devices Advisory Panel.
- Special Assistant to the Director, Division of Cardiovascular Devices (12 years) working with all of the Divisions in the FDA Center for Devices and Radiological Health/Office of Device Evaluation, and with experience in the Center for Biologics and the Center for Drugs.
- Working with industry (US and International), academics, and other government agencies in developing policy and in designing clinical study protocols, analyzing and interpreting data, and preparing Advisory Panel presentations.
- Co-author of FDA Guidance on Clinical Trial Design.
- Lead clinical reviewer for transcatheter heart valve repair and replacement studies from the inception of the field to 2013. Worked with companies to design the studies, analyzed and reviewed the data from the studies, presented at the Advisory Panels.
- Lead clinical reviewer for Mechanical Circulatory Assist devices from 2002-2009. Developed performance goals for bridge-to-transplant and worked with companies to design studies, analyzed the data, and gave the FDA clinical presentation at Advisory Panel meetings.
- Lead clinical reviewer for medical devices for the fields of heart failure, treating myocardial ischemia, closing the left atrial appendage, PFO's and septal defects, embolic protection, ECMO, therapeutic hypothermia, and cardiopulmonary resuscitation.
- Experience in developing and interpreting clinical studies for vascular grafts, neurological devices, stroke studies, infusion/implantation of biologics and cellular therapy for heart failure and angina, atrial fibrillation, vascular stents, pressure monitors, organ preservation, and pulmonary devices for treating emphysema.
- Particular interest and expertise in neurological effects of cardiovascular devices and studies for stroke, TIA, and migraine.
- Highly experienced in databases (STS, INTERMACS, and TCT).
- Developed performance goals and objective performance criteria for left ventricular assist devices and for transcatheter heart valves.
- Broad experience in working with statisticians on statistical design and interpretation of clinical trials.
- Long-term experience working with FDA epidemiologists on design and conduct of post-market studies.
- Extensive experience in working with engineers and veterinarians on preclinical study issues.
- FDA representative on the Valve Academic Research Consortium and the Mitral Valve Academic Research Consortium developing trial design, endpoint, and adverse event definitions for transcatheter valves.
- Advised FDA management on new trends in medical device development and use.
- Worked closely with CMS on reimbursement issues for medical devices.
- Membership on Data Safety Monitoring Boards for large NIH studies.
Center for Medical Devices
Mount Sinai Heart
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box 1028
New York, NY 10029-6574