Epi-K Approved for Sale in USA, Europe, and Japan.ANTONY, France & DOYLESTOWN, Pa. -- Moria announced today that the Epi-K(TM), its disposable epikeratome for Epi-LASIK, has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for marketing in the United States. The device has also recently received a CE Mark authorizing sales in the European Community and has been approved for sale in Japan. The Epi-K(TM) is utilized to mechanically separate the epithelium from Bowman's membrane Bowman's membrane n. See limiting layer of cornea. Bowman's membrane see corneal laminae. . The epithelial flap is then folded back prior to laser ablation, and subsequently returned to its original position. The procedure preserves the structural integrity of the stroma stroma /stro·ma/ (stro´mah) pl. stro´mata [Gr.] the matrix or supporting tissue of an organ.stro´malstromat´ic stro·ma n. pl. stro·ma·ta 1. and is expected to minimize discomfort, shorten the length of visual recovery, and reduce the incidence of haze associated with other surface ablation procedures, such as PRK PRK photorefractive keratectomy. Photorefractive keratectomy (PRK) A procedure that uses an excimer laser to make modifications to the cornea and permanently correct myopia. and LASEK Noun 1. LASEK - a refractive surgery procedure that reshapes the cornea laser-assisted subepithelial keratomileusis eye operation, eye surgery - any surgical procedure involving the eyes . In rigorous clinical trials at 13 sites in 9 countries on over 500 eyes, the Epi-K(TM) achieved excellent results. All clinical investigators reported that the device produced very high quality epithelial flaps and that postoperative pain and visual recovery compared favorably with other surface ablation procedures. Dr. Barrie Soloway, principal investigator at one of the US sites, noted that 88% of patients indicated they could return to work within three days following surgery. Moria plans to begin filling orders for the Epi-K(TM) in late April. Further information will be available on the Moria website, www.moria-surgical.com, and at the scientific presentations the company has scheduled during the upcoming ASCRS ASCRS American Society of Cataract and Refractive Surgery ASCRS American Society of Colon and Rectal Surgeons Symposium and Congress in Washington, DC. |
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