United States regulatory approval of medical devices used for endovascular neurosurgery: A two-decade review of FDA regulatory files.

Abstract

The evolution of neuroendovascular technologies has progressed substantially. Over the last two decades, the introduction of new endovascular devices has facilitated treatment for more patients, and as a result, the regulatory environment concerning neuroendovascular devices has evolved rapidly in response. To examine trends in the approval of neuroendovascular devices by the United States Food and Drug Administration (FDA) over the last 20 years. Open-access US FDA databases were queried betwee