Epi-K Approved for Sale in U.S., EU and Japan
Moria has announced that the Epi-K, the company's disposable epikeratome for Epi-LASIK, has received FDA approval for marketing in the U.S.
The device has also recently received a CE Mark authorizing sales in Europe and has been approved for sale in Japan.
The Epi-K is used to mechanically separate the epithelium from Bowman's membrane, a thin membrane in the cornea between the epithelium and the stroma. 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 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 (photorefractive keratectomy) and LASEK (laser epithelial keratomileusis). Moria plans to begin filling orders for the Epi-K in late April.