Avedro Inc. won CE Mark approval for its Vedera system in the European Union, clearing the way for it to begin marketing its Keraflex procedure for myopia and keratoconus.
The Waltham, Mass.-based company said the system, which uses thermal energy to flatten the surface of the cornea in the eye, is designed to treat near-sightedness and the progressive eye disease without removing any tissue. Keratoconus occurs when the cornea thins, changing its architecture into a cone.
The device delivers a single, low-energy microwave pulse that lasts less that one second. The pulse raises the temperature of the stroma, the cornea’s middle layer, creating a lesion designed to flatten the center of the cornea to alter its refractive index.
Avedro said it will immediately begin commercializing the technology across the pond and in Asia. The company plans to file for an investigational device exemption from the Food & Drug Administration in mid-2010, according to its website.