STORZ VITREON LIQUID FLUOROCARBON PMA STUDY NEEDS NEW ENDPOINTS
This article was originally published in The Gray Sheet
Executive Summary
STORZ VITREON LIQUID FLUOROCARBON PMA STUDY NEEDS NEW ENDPOINTS, FDA's Ophthalmic Devices Panel advised during a May 20 panel meeting in Bethesda, Maryland. Summarizing the panel's discussion, Chairman Doyle Stulting, MD, PhD, Emory University, Atlanta, commented, "The general feeling was that the endpoints that were analyzed in the [premarket approval application] data ...were probably inappropriate given the nature of the device and its intended use" for the intraoperative treatment of complicated retinal detachments.