Carotid stent investigational device exemption applications sought by FDA.
This article was originally published in The Gray Sheet
Executive Summary
CAROTID STENT INVESTIGATIONAL DEVICE EXEMPTION SUBMISSIONS SOUGHT BY FDA to ensure that safety and efficacy information is gathered on the off-label use of stents in the carotid artery, the agency says. The agency is in the process of drafting a suggested clinical protocol for IDE trials.