STAAR Surgical Receives CE Mark Approval for KS-X Preloaded Hydrophobic Acrylic Lens Injector System
STAAR has been offering the KS-X system, which mates a preloaded delivery system manufactured by STAAR Japan with an independently sourced acrylic lens, in the Japanese market for two years. The STAAR system enables lens delivery into the eye through a 2.8 millimeter incision and is compatible with the most commonly used small incision cataract extraction procedures. It is the only preloaded lens delivery system in the world that provides single or bi-manual injection options in one single design, allowing for the smoothest IOL injection methods compared with traditional delivery systems.
"Receipt of the CE Mark is an important accomplishment and a validation of
STAAR Japan's expertise in the development of preloaded delivery systems for
foldable IOLs that enable precise delivery of the lens during cataract
surgeries," said
A foldable IOL is a prosthetic lens used to replace a cataract patient's
natural lens after it has been extracted in minimally invasive small incision
cataract surgery. STAAR manufactures IOLs out of silicone and Collamer(R),
STAAR's proprietary biocompatible collagen copolymer lens material. STAAR
"The introduction of our KS-X preloaded delivery system will be primarily
focused on our direct markets and other key markets in
First shipments of the product in key European and Australian markets are expected to begin in late June. The acrylic-lens-based preloaded injector is not approved for sale in the U.S.
About
Safe Harbor
All statements in this press release that are not statements of historical
fact are forward-looking statements, including statements about any of the
following: projections of any financial items; the plans, strategies, and
objectives of management for future operations or prospects for achieving such
plans; the success of the KS-X injector system in the
These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the need to satisfy the forthcoming judgment in the Parallax case or post an appeal bond and the resulting effect on our liquidity, our limited capital resources and limited access to financing, the need to defend other litigation similar to the Parallax case and to satisfy judgment in the event of an adverse ruling in that case, for which we have taken no reserve, the effect the global recession may have on sales of products, especially products such as the ICL used in non-reimbursed elective procedures, the challenge of managing our foreign subsidiaries, the risk that we will not succeed in introducing improved products that restore the profitability of our U.S. IOL product line, our ability to resolve FDA concerns over the clinical study for the Toric ICL and to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general in the U.S.
CONTACT: Investors Media EVC Group EVC Group Douglas Sherk, 415-896-6820 Christopher Gale 646-201-5431 Michael Pollock, 415-896-6862
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