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Avedro receives CE mark for system to perform Keraflex procedure

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WALTHAM, Mass. — Avedro announced that its Vedera system for performing the Keraflex corneal flattening procedure received the European Union's CE mark, according to a press release from the company.

"I am pleased by how quickly Avedro has been able to transform its thermo-biomechanics platform technology into a commercially available ophthalmic device," David Muller, PhD, Avedro president and CEO, said in the release. "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."

The Keraflex procedure is designed to flatten the cornea to correct myopia and reverse keratoconus. The noninvasive procedure thermally alters the tension of collagen fibers in the cornea without the need to remove tissue. It alters refraction without compromising the cornea's biomechanical integrity, the release said.

Avedro plans to market the Keraflex procedure in Europe and Asia and to collaborate with surgeons adopting the procedure.

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