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Press Release Source: STAAR Surgical Company
STAAR Surgical Receives FDA Clearance for the Epiphany(TM) Injector System
* On Thursday June 11, 2009, 8:00 am EDT
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* STAAR Surgical Company
MONROVIA, Calif., June 11 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA - News), 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® 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.
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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 the lens haptics which is another clear advantage that will help differentiate this the new system in the market place.
First shipments of the product should begin in July with full release to the market in the August timeframe.
About STAAR Surgical
STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products include the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 50 countries. Collamer® is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available at www.staar.com.
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