VITROPHAGE'S PMA FOR VITREON RETINAL TAMPONADE IS APPROVABLE DESPITE HEAVY CRITICISM FROM PANEL; INFINITECH'S PERFLUORON PMA CLEARS PANEL WITH PRAISE
This article was originally published in The Gray Sheet
Executive Summary
Two intraoperative retinal tamponades -- Vitrophage's Vitreon and Infinitech's Perfluoron -- were deemed approvable by FDA's Ophthalmic Devices Panel at an Oct. 19 session in Gaithersburg, Maryland. Both firms are seeking approval of the liquid perfluorocarbon devices as intraoperative surgical aids to assist in reattaching the retina in patients with certain complex retinal complications.