KeraVision Intacs "Reversibility" Balances Additional Risk, Panel Says
This article was originally published in The Gray Sheet
Executive Summary
KeraVision should agree to conduct at least two years of postmarket studies of the thickest version of the Intacs intrastromal corneal ring segments (ICRSs) as a prerequisite for FDA approval, the agency's Ophthalmic Devices Panel concluded at a Jan. 12 meeting in Rockville, Maryland.