CF X-LINKER
Abstract
The CF X-LINKER® is an ophthalmic medical device for corneal cross-linking (CXL), manufactured by Iromed Group S.r.l. (Rome, Italy). It is used primarily in the treatment of keratoconus and other corneal ectasias.
Corneal cross-linking (CXL) is a minimally invasive procedure that uses UV-A light combined with a riboflavin (vitamin B2) photosensitizer to create new collagen cross-links within the corneal stroma, halting the progression of conditions like keratoconus that cause the cornea to thin and bulge.
Operating Parameters
UV Power output is adjustable from 1 to 30 mW/cm², with both continuous and pulsed UV emission modes available. The beam diameter is adjustable from 3 to 12 mm, allowing the treatment zone to be tailored to each patient's corneal morphology.
Selectable Treatment Protocols
The CF X-LINKER® supports multiple protocols: Dresden EPI-OFF (the conventional standard-of-care approach), Custom Fast CXL EPI-ON, Iontophoresis, Infectious Keratitis CXL, fully customizable user presets, and a Demo mode.
EPI-OFF means the corneal epithelium is removed before riboflavin application, allowing deeper penetration. EPI-ON (transepithelial) is a less invasive, epithelium-intact approach — faster recovery, lower discomfort.
Unique Feature: Custom Fast CXL (cfCXL)
The CF X-LINKER® is the only system capable of performing Custom Fast CXL (cfCXL), a customized, low-power EPI-ON cross-linking treatment. Its proprietary software uses a mathematical model to automatically calculate procedure parameters based on each patient's topographic and pachymetric values, tailoring the treatment to their specific corneal anatomy while maintaining high safety standards.
Custom Fast CXL is supported by several international publications, including a 7-year follow-up study. It can only be performed using the CF X-LINKER® system in combination with RIBOCROSS® te or RIBOFAST riboflavin solutions.
Open System
The device is an open system, meaning it is compatible with any riboflavin solution available on the market, without requiring activation cards or incurring additional material costs.
Interface & User Experience
All operations are managed through a 10-inch touchscreen monitor with exclusive proprietary software. An integrated camera allows real-time live monitoring of the entire treatment. At the end of each procedure, the system generates a treatment report which can be saved to an internal database, exported via a USB port, or printed.
Clinical Indications
The device is indicated for: Keratoconus, Corneal Ectasias, Post PRK/LASIK/RK ectasias, Pellucid Marginal Degeneration, and Infectious Keratitis.
Manufacturer
Manufactured by Iromed Group S.r.l., Rome, Italy. Distributed in several markets by SERVImed Industrial S.r.l.
The CF X-LINKER® stands out from competing CXL systems primarily because of its adjustable beam size, wide power range, EPI-ON/EPI-OFF flexibility, and the exclusive Custom Fast CXL algorithm — making it one of the more versatile and patient-customizable corneal cross-linking platforms on the market.
