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China Food and Drug Administration (CFDA) Approves Avedros KXL System

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Published on : Nov 03, 2015

Avedro, Inc., a medical device and ophthalmic pharmaceutical company recently announced that it received an approval from the China Food and Drug Administration (CFDA) for its KXL Cross-Linking System. The KXL Cross-Linking System is the very first cross-linking method to obtain approval in the People’s Republic of China. The KXL device, a cross-linking procedure, is a combination of UVA irradiation and riboflavin ophthalmic solution indicated to treat post-LASIK ectasia and keratoconus. Both, post-LASIK ectasia and keratoconus are sight threatening conditions. 

Zhou Xing Tao, the director of refractive surgery center and professor of ophthalmology said that he being the first ophthalmic surgeon to use the KXL device in China, he has been clinically testing its effectiveness and safety for three years. With the approval of the KXL system, patients suffering from post-LASIK ectasia and keratoconus will have full access to the corneal cross-linking, stated Zhou. According to David Muller, the CEO of Avedro, the approval of KXL system in China will play a significant role in the China medical devices sector. It is an important achievement for the team of Avedro, clinical investigators in China, and for the distribution partners in China, stated David Muller. 

When it comes to the medical sector, China has the largest growth potential for corneal cross-linking with an estimate of above 1000 refractive centers and 1.4 mn keratoconic eyes, added David. With this, Avedro will have the best untapped opportunity to expand its services. Avedro, a privately held medical device and pharmaceutical company, has advanced into the science and technology of refractive correction and corneal cross-linking. Avedro uses a network of medical device distributors to distribute its new products across the United States and in other regions outside the U.S. Some of the products of Avedro, which are sold outside the U.S. are the UV-X devices, Mosaic Systems, and the KXL systems. 

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