Food and Drug Association Approval Process for Devices Used in Endovascular Treatment of Stroke.

Abstract

This article reviews the Food and Drug Administration's (FDA's) process for approval of new medical devices and describes the evolution of endovascular devices used for the treatment of acute ischemic stroke. Several recent studies have established the benefit of endovascular treatment of acute ischemic stroke from emergent large vessel occlusion. This has led to endovascular treatment becoming the usual care in acute stroke management and has generated greater-than-ever interest in the developm