Presbia’s Flexivue™ Micro-Lens Receives European Market Approval

Presbia, a leader in the development and marketing of a surgical solution for presbyopia, today announced its Flexivue™ micro-lens received CE certification for its products sold within the European Economic Area (EEA). Specifically, the CE mark certifies that Flexivue™ has met European Union consumer safety, health and environmental requirements.

This certification marks the completion of another significant step toward the commercialization of the Flexivue™ lens, a practical, safe, and reversible implantable alternative to reading glasses for the hundreds of millions of adults that suffer from presbyopia-the gradual loss of near vision that often affects people over the age of 40.

Zohar Loshitzer, chief executive officer of Presbia, commented, “Today’s CE certification of the Flexivue™ lens validates our technology and will enable us to move forward with commercialization of our solution for the huge presbyopic market by mid-2010.”

As part of this process, Presbia is conducting post-market surveillance of the Flexivue lens at the Institute of Vision and Optics of the University of Crete under the supervision of Professor Ioannis Pallikaris, widely regarded as the “father” of LASIK surgery and chair of the Presbia Medical Advisory Board. In addition, Prof. Pallikaris is overseeing the development of a training program for surgeons at the Institute. Presbia also anticipates two additional post-market surveillance centers to be established in Europe in the near future.

About Flexivue™ Micro-Lens

Presbia’s revolutionary solution to presbyopia utilizes the implanting of the Flexivue™ lens in the corneal stroma of the eye. The hydrophilic polymer lens is just three millimeters in diameter and less than 20 microns in edge thickness, and is made of similar materials to those that have been used in intraocular lenses for the past 20 years. The lens is placed in a “pocket” created in the cornea by a femtosecond laser-the same kind of laser routinely used for LASIK surgery. The eye surgeon inserts the lens into the pocket using a proprietary device developed by Presbia.

The pocket then seals itself, holding the lens in place in the center of the visual axis. The lens can stay in place permanently, or can be easily and safely removed if, for example, the patient’s presbyopia advances and a stronger prescription is required. The procedure typically takes less than 10 minutes, is performed on the non-dominant eye, and does not require general anesthesia. The Flexivue™ micro-lens is implanted utilizing standard femtosecond lasers to create the pocket, therefore the procedure requires no additional capital investment by the surgeon’s practice.

Source
Presbia

source : www.medicalnewstoday.com

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