Avedro, a privately held medical device company and a sponsor of two completed US FDA multi-center clinical trials for corneal cross-linking, said that its KXL System for performing accelerated corneal cross-linking (KXL) has received the European Union’s (EU) CE mark.
The CE mark certifies that the KXL System has met the EU’s health and safety standards and opens the door to immediate commercialisation across the European Economic Community and in other countries recognising the CE mark.
Avedro president and CEO David Muller said that Lasik Xtra is one of the company’s new procedures made possible by its KXL System. Lasik Xtra can restore the strength of the cornea with a simple five-minute treatment accompanying Lasik surgery.
“Lasik Xtra helps patients avoid the risk of post-Lasik ectasia, which has become a troublesome and unpredictable problem. In addition, our accelerated KXL procedure offers a much more acceptable treatment for patients with keratoconus and for those already suffering from post-Lasik ectasia,” Muller said.