STAAR has announced that FDA has granted 510(k) clearance for Epiphany Injector System for use with the Affinity Collamer Three-Piece NTIOL and the Elastimide Silicone NTIOL.
Epiphany has been designed to combine both ease of use with controlled delivery. The injector system is intended for single use and offers the flexibility of either twist or push insertion techniques.
Epiphany provides effortless and controlled insertion through a 2.8mm incision and, being a single use product, ensures a sterile pathway into the eye. The Epiphany’s planar delivery of the lens into the eye, offers controlled release of the lens haptics.
Barry Caldwell, President and CEO of STAAR, said: The Epiphany Injector System is an important extension of STAAR Japan’s expertise in the area of preloaded delivery systems for foldable IOLs which have been very successful in the Japanese market. This product will enhance the ability of surgeons to accurately deliver the Collamer Three-Piece NTIOL into the eye and it serves as the forerunner in our regulatory pathway for potential approval of the preloaded delivery system in the US.