Mount Sinai Establishes Center for Cardiovascular Medical Devices

Services available through CMeD include cardiac medical device assessment and evaluation, regulatory approval strategies, advanced clinical trial design, data interpretation, assistance with FDA submissions, and potential access to clinical testing at Mount Sinai.

In addition, CMeD will be a training center for future medical professionals wishing to gain experience in advanced clinical trial design and evaluation of medical devices. To do so, Mount Sinai Heart has Recruited Julie Swain, MD, a practicing cardiothoracic surgeon for more than 25 years and clinical trials expert who has consulted for the US Food and Drug Administration (FDA). In addition to her role as Director of CMeD, Dr. Swain will serve as Professor of Cardiovascular Surgery and Director of Clinical Research in the Department of Cardiovascular Surgery at Mount Sinai.

“Our mission at CMeD will be to provide the critical expertise and guidance needed by medical device companies, inventors, and researchers to further develop and test innovative cardiac medical devices that show promise to advance the field of cardiovascular medicine and the heart health of patients around the globe,” said Dr. Swain. “If you need help at any stage of your promising cardiac medical device’s research and development, ranging from the earliest development of your medical device to the final regulatory FDA approval, our experienced team at CMeD at Mount Sinai Heart can help.”

“Dr. Swain is internationally acclaimed for her leadership as the key advisor on cardiac device trial design and data interpretation for the Food and Drug Administration over the past decade,” commented David Adams, MD, chairman of the department of cardiovascular surgery. “She has been at the center of every major cardiac device trial in this role, and is thus uniquely positioned to lead our medical device program going forward. I expect this program to be a national level resource that will bring us access to a number of cutting edge clinical research opportunities, and assure our position as a leader in this space.”

Mount Sinai Heart is ranked No. 13 for heart services by US News & World Report, and is home to the largest catheterization laboratory in the United States. Considered a world leader in all facets of cardiology care and research, it is also a world leader in mitral valve reconstruction.

Related Links:
Mount Sinai Heart
Icahn School of Medicine at Mount Sinai