Avedro, a Massachusetts-based medical device company, has received European CE mark approval for Vedera System for performing Keraflex procedure.
The CE Mark certifies that Vedera has met the EU’s health and safety standards and opens the door to commercialisation across the European Economic Community and in other countries recognising the CE Mark.
The Keraflex procedure is a non-invasive, incision-less ophthalmic procedure for flattening the cornea. Because Keraflex thermally remodels the cornea without the removal of any tissue, the procedure offers the ability to induce refractive change without weakening the cornea’s biomechanical integrity, as happens with LASIK and other refractive correction procedures.
In its European clinical trials for the correction of myopia and the treatment of keratoconus, Avedro has investigated a two-step procedure whereby Keraflex provides corneal flattening to achieve refractive correction and concomitant collagen crosslinking stabilizes the cornea.
Furthermore, Avedro plans to immediately begin commercialisation of the Keraflex procedure throughout Europe and Asia, and looks forward to training and collaborating with its ophthalmic surgeon partners.
John Marshall, professor of institute of ophthalmology at University College, London, said: “The Keraflex 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. The synergistic use of corneal collagen crosslinking improves the stability of the induced refractive effect while also working to halt disease progression.”
David Muller, president and CEO of Avedro, said: “I am pleased by how quickly Avedro has been able to transform its Thermo-biomechanics platform technology into a commercially available ophthalmic device. Avedro has been conducting clinical trials to treat myopia and keratoconus with the Keraflex procedure and is extremely pleased with the results. CE Mark certification is an important milestone for the company, and also represents a vital new offering to ophthalmic patients and their physicians.”