System for accelerated corneal crosslinking receives CE mark

Waltham, MA-A system for performing accelerated corneal crosslinking (KXL, Avedro) has received the European Union’s (EU’s) CE mark, which certifies that the system has met the EU’s health and safety standards and opens the door to immediate commercialization across the European economic community and in other countries recognizing the CE mark.

Every normal LASIK procedure weakens the cornea, said David Muller, PhD, president and chief executive officer of Avedro. Studies have found corneal crosslinking, which first was performed 12 years ago in Europe as a 1-hour procedure, to be safe and effective in strengthening the cornea and halting the progression of keratoconus. Research also has demonstrated that crosslinking can strengthen and stabilize post-LASIK ectasia.

The accelerated corneal crosslinking procedure that recently received the CE mark takes minutes and can be incorporated into a standard LASIK procedure to restore corneal strength, according to the company.

“Our accelerated . . . procedure offers a much more acceptable treatment for patients with keratoconus and for those already suffering from post-LASIK ectasia,” Dr. Muller said.

John Marshall, PhD, FMedSci, FRCPath, FRCOphth(Hon), expects that one of the procedures (LASIK Xtra) made possible by the new system “will become the standard of care during a LASIK procedure due to its ability to restore the cornea to its original strength. Crosslinking is well known to surgeons throughout the world, and [the aforementioned procedure] makes an already familiar procedure faster, easier, and more acceptable.”