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Microkeratome for epi-LASIK to launch at ESCRS
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MADRID, Spain — The first microkeratome to produce an epithelial sheet with no cutting is soon to get 510k approval, according to a CIBA Vision spokesperson who spoke to Ocular Surgery News here at the Congress of the European Society of Ophthalmology. The 510k was submitted about two weeks ago, according to company officials, who expect to launch the new device at the upcoming European Society of Cataract & Refractive Surgeons in Munich this September.
The Centurion SES microkeratome for epi-LASIK removes the epithelium in a sheet that is consistent in thickness. Epi-LASIK is a laser epithelial keratomileusis-like technique in which mechanical separation of the corneal epithelium is accomplished without the use of alcohol. The procedure was developed by Ioannis G. Pallikaris, MD, from the University of Crete.
Additionally, no flap is made, and no cuts are made. The system is equipped with what the company is terming a separator, which only removes the epithelium. The epithelium is easily put back into place after the epi-LASIK procedure and acts like a natural or “live” contact lens. The basal epithelial cells heal via cell mitosis, producing new cells for wounds. This form of refractive surgery is associated with less pain, less risks, no cutting and no late vision recovery.
The Centurion SES microkeratome was recently approved for LASIK by the U.S. Food and Drug Administration. This microkeratome features a patented disposable blade-cartridge system, allowing surgeons the capability to switch from LASIK to epi-LASIK.
The Centurion SES microkeratome is manufactured by Switzerland’s BioVision and will be distributed globally by CIBA Vision.