WALTHAM, Mass.--(BUSINESS WIRE)--Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company announces today the Canadian approval for the company’s KXL II System. The KXL II System performs a procedure called PiXL™ (Photorefractive Intrastromal Cross-Linking) which has the potential to deliver non-surgical correction of myopia, and improve cataract surgery outcomes.
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’ being held in conjunction with the AECOS European Meeting on June 28th, 2014.
David Muller, PhD, CEO of Avedro states, “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. 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 to perform Lasik Xtra® and Accelerated Cross-Linking for keratoconus and post-LASIK ectasia.
About Avedro, Inc.
Avedro is a privately held medical device and pharmaceutical company advancing the science and technology of corneal cross-linking and refractive correction. Avedro’s products include capital equipment and related single dose pharmaceuticals. The KXL System’s cross-linking, in combination with its pharmaceuticals, is used to treat keratoconus and corneal ectasia outside the United States. Those products are also used in a procedure known as Lasik Xtra. Over 100,000 treatments have been successfully performed outside the US using Avedro’s KXL System.
Avedro distributes its products in 62 countries through 33 ophthalmic distributors with 115 sales and service representatives. Avedro products that have received CE Mark include: the KXL System for performing Lasik Xtra and Accelerated Cross-Linking, the KXL II System for performing PiXL, and the Avedro family of proprietary single dose pharmaceutical formulations.
Avedro’s KXL System and single dose pharmaceutical products are currently being used in three Phase III US clinical trials involving over 100 US clinical sites. Avedro products are not for sale in the US.