Thermo-biomechanical system gets CE mark

Waltham, MA

-A thermo-biomechanical system (Vedera, Avedro) for performing a proprietary procedure (Keraflex) to flatten the cornea in the treatment of myopia and keratoconus has received the European Union (EU) CE mark.

“CE mark certification is an important milestone for the company and also represents a vital new offering to ophthalmic patients and their physicians,” said David Muller, PhD, president and chief executive officer of Avedro.

Through the noninvasive, incisionless procedure performed by the device, the cornea is thermally remodeled without the removal of any tissue, thereby inducing refractive change without weakening the cornea’s biomechanical integrity.

In its European clinical trials for the correction of myopia and the treatment of keratoconus, the company has investigated a two-step procedure whereby the cornea is flattened to achieve refractive correction while concomitant collagen crosslinking stabilizes the cornea.

“The . . . procedure, by thermally altering the tension of collagen fibers, induces a corneal flattening and achieves a more prolate cornea. This confers refractive correction, and, for the keratoconic cornea, smoothing of the irregular cornea, thereby improving visual acuity,” said John Marshall, PhD, Institute of Ophthalmology, University College London. “The synergistic use of corneal collagen crosslinking improves the stability of the induced refractive effect while also working to halt disease progression.”

The company plans immediately to begin to commercialize the procedure throughout Europe and Asia.