Johnson & Johnson Vision Receives CE Mark Approval for New Corneal Refractive Technology, the ELITA Femtosecond Laser System
ELITA System brings novel technology and features to deliver a new paradigm in lenticule removal with SILK Procedure, the newest lenticular procedure1,3
[LONDON, ENGLAND – March 1, 2023] – Johnson & Johnson Vision,* a global leader in eye health and part of Johnson & Johnson MedTech,i today announced that it has received CE Mark approval for its next-generation laser vision correction solution, the ELITA Femtosecond Laser System.** The new laser will allow surgeons to perform refractive correction on patients with myopia, with or without astigmatism, via the SILK Procedure, a new lenticular procedure (Smooth Incision Lenticule Keratomileusis). The ELITA System leverages an ultra-precise laser pulse and fast laser delivery system to deliver a very smooth corneal surface, making lenticular removal extremely easy.1,2,3
“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,” said Xiao-Yu Song, Global Head of R&D,*** Johnson & Johnson Vision. “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 cornea4,5
- better preservation of biomechanical strength of the cornea and faster nerve regeneration due to less corneal fibers being cut5
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 for ophthalmologists in select countries across Asia Pacific and Europe.
**The ELITA Femtosecond Laser System is not yet approved for use in the U.S. This content is intended for Healthcare Professionals only, not for the general public.
About Johnson & Johnson Visioni
At Johnson & Johnson Vision, part of Johnson & Johnson MedTechi, we have a bold ambition: to change the trajectory of eye health worldwide. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts, and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better, live better. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
Johnson & Johnson Vision Media Contact:
+44 7770 337800
IMPORTANT SAFETY INFORMATION – Europe
For Healthcare Professionals Only. Please reference the Instructions for Use for a complete list of Indications and Important Safety Information and contact our specialists in case of any question.
© Johnson & Johnson Surgical Vision, Inc. 2023. All rights reserved.
*Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
** ELITA has not received 510(k) clearance in the United States.
***Xiao-Yu Song is an employee of Johnson & Johnson Vision, Inc., serving as Global Head of R&D.
1 DOF2023RF4002. ELITA Femtosecond Laser Device Description
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.
i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.