The KXL II device is designed to deliver specific light patterns to the cornea based on the patient’s own topographic data, which is collected during routine pre-operative screening. This allows cross-linking to be customized to a patient’s specific refractive needs.
Avedro has already begun installing its new KXL II device in multiple sites around the world. Early clinical results, with follow-up approaching one year, will be discussed at the upcoming 3rd International Congress on Advanced Corneal Cross-Linking held in conjunction with the American-European Congress of Ophthalmic Surgery European Meeting on June 28 in Barcelona, Spain.
“With this approval of the KXL II, Canada joins the 28 members of the European Union that have received the CE mark and approval to use this advanced technology," said David Muller, Ph.D., CEO of Avedro. "This revolutionary procedure for treating myopia and astigmatism 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. In addition, it has the potential to improve the outcomes of routine cataract procedures by non-surgically reducing post-operative astigmatism.”
Currently, Avedro’s approved KXL system is being used in Canada and other non-U.S. markets to perform Lasik Xtra and accelerated cross-linking for keratoconus and post-LASIK ectasia.
The KXL system is being used in three Phase III U.S. clinical trials involving more than 100 clinical sites. Avedro products are not for sale in the United States.