CDRH Guardedly Optimistic About Brachytherapy For In-Stent Restenosis
This article was originally published in The Gray Sheet
Executive Summary
FDA Center for Devices and Radiological Health Director David Feigal praised the quality of evidence thus far demonstrating the safety and effectiveness of vascular brachytherapy in treating in-stent restenosis. At the same time, however, he cautioned that the agency would thoroughly review the data before making the therapy widely available.