STAAR Surgical Receives FDA Clearance for the Epiphany(TM) Injec...( MONROVIA Calif. June 11 /- STAAR Surg...)

MONROVIA, Calif., June 11 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the FDA has granted 510(k) clearance for its Epiphany Injector System for use with the Affinity(TM) Collamer(R) Three-Piece NTIOL and the Elastimide(TM) Silicone NTIOL. Introduction of the Epiphany will usher in a new era of insertion devices for the company and pave the way for the future introduction of a preloaded injector for the U.S. market.

STAAR named this product "Epiphany" based on the genesis of the product: the realization that the revolutionary proprietary technology used in our preloaded products outside of the U.S. could be modified and incorporated into a stand-alone injector for IOLs in other markets. Epiphany has been designed to combine both ease of use with controlled delivery. The Epiphany injector system is intended for single use and offers the flexibility of either twist or push insertion techniques - a unique feature of STAAR's IOL delivery systems.

"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," said Barry G. Caldwell, President and CEO of STAAR Surgical. "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 U.S."

As the Epiphany provides for effortless yet 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 t
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