CE Mark for Avedro’s KXL II ™ Non-Surgical Myopia Correction System

Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company, has gained CE Mark clearance for its KXL II System, building on the company’s portfolio of technologies aimed at non-surgical correction of ophthalmic conditions.

Background

Ophthalmic technologies company Avedro focuses on the science and technology of corneal cross-linking and refractive correction. Its products include capital equipment and related single dose pharmaceuticals. Over 75,000 surgeries have been successfully performed outside the US using Avedro’s KXL System. KXL is currently used to enhance Lasik outcomes in a procedure known as Lasik Xtra and its accelerated cross-linking, in combination with its pharmaceuticals, is also used to treat several important and debilitating ophthalmic pathologies.

The KXL II System has the potential for non-surgical correction of myopia, as well as improving cataract surgery outcomes, with a procedure called PiXL™ (Photorefractive Intrastromal Cross-linking).

Other Avedro products that have gained CE Mark approval include the KXL® System for performing Lasik Xtra® and Accelerated Cross-linking, and the Avedro family of proprietary single dose riboflavin formulations.

Physician comments

“As one of the first KXL II clinical sites, we experienced the amazing capabilities of customized accelerated cross-linking to achieve specific, reproducible and interim-stable refractive changes on the cornea,” said A. John Kanellopoulos, MD, NYU Medical School and Member of Avedro’s Medical Advisory Board. “It seems to me that every surgeon who has performed cross-linking has experienced refractive corneal changes. We now have a way to design and customize these refractive changes. If these initial clinical results continue to be repeated, as I believe they will, the potential seems unlimited.”

Company c0mments 

David Muller, PhD, CEO of Avedro states, “The KXL II and PiXL procedure continue our mission to make refractive correction truly non-surgical. Treating myopia and other refractive disorders with PiXL has the potential to open up refractive correction to millions of people who have never considered Lasik surgery before, but would consider a non-surgical alternative.”

Source: Avedro, Inc., Business Wire

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