Avedro Receives the European Union’s CE Mark
for its Vedera™ Ophthalmic Device
The company prepares for immediate commercial launch throughout Europe and Asia
April 20, 2010 12:39 PM Eastern Daylight Time
WALTHAM, Mass.--(EON: Enhanced Online News)--Avedro, Inc. today announced its Vedera™ System for
performing the Keraflex® procedure has received the European Union’s CE Mark. The CE Mark certifies the
Vedera has met the EU’s health and safety standards and opens the door to commercialization across the European
Economic Community and in other countries recognizing the CE Mark.
“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,” said David Muller, PhD, President and CEO of Avedro.
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 unique ability to
induce refractive change without weakening the cornea’s biomechanical integrity, as happens with LASIK and other
refractive correction procedures.
Keraflex KXL, Corneal Flattening and Corneal Stabilization
In its European clinical trials for the correction of myopia and the treatment of keratoconus, a progressive disease of
the cornea, Avedro has investigated a two-step procedure whereby Keraflex provides corneal flattening to achieve
refractive correction and concomitant collagen crosslinking stabilizes the cornea.
“The Keraflex procedure, by thermally altering the tension of collagen fibers, induces a corneal flattening and
achieves a more prolate cornea. This confers refractive c