J&J Vision Receives CE Mark Approval for the ELITA Femtosecond Laser System
Johnson & Johnson Vision has received CE Mark approval for the ELITA Femtosecond Laser System for laser vision correction. The new laser will allow surgeons to perform refractive correction on patients with myopia, with or without astigmatism, via a new lenticular procedure called the SILK (Smooth Incision Lenticule Keratomileusis) procedure. The ELITA System leverages an ultra-precise laser pulse and fast laser delivery system designed to deliver a smooth corneal surface, making lenticular removal easy, according to a company news release.
“The ELITA System represents a generational leap in corneal refractive technology, leveraging advanced technologies and designs to deliver improvements in surgical experiences and patient outcomes,” Xiao-Yu Song, Global Head of R&D, Johnson & Johnson Vision, said in a company news release. “Early clinical results have shown promising visual outcomes and patient satisfaction data, leading us to believe that the ELITA System, and the SILK procedure, has the potential to elevate the standard of care for patients with myopia.”[3,4]
The SILK procedure brings to market a proprietary biconvex lenticule shape that’s designed to offer the following advantages:
- posterior and anterior surface matching without any corneal folding when the lenticule is removed from the cornea
- better preservation of biomechanical strength of the cornea and faster nerve regeneration due to less corneal fibers being cut[5]
The ELITA Femtosecond Laser System is indicated for myopia patients with or without astigmatism up to -12DS, up to -6DC, with sum of sphere & cylinder between -1.00D and -12:00D using minus cylinder convention.[3] It is also indicated for use in LASIK flap procedures.
It will soon be available in select countries across Asia Pacific and Europe. The ELITA Femtosecond Laser System is not yet approved for use in the United States.
References
1 DOF2023RF4002. ELITA Femtosecond Laser Device Description
2 DOF2022OTH4005.
3 Manual 0155-3006
4 EuroTimes Supplement February 2023 | A Corneal Refractive Update on Lenticule Extraction Technology and Outcomes
5 DOF2022OTH4006 ELITA Femtosecond Platform – Biconvex Lenticule Design.