PRESBIA adds two new Post-Market surveillance sites in Europe and South America PDF Print E-mail

Sites in Italy & Colombia, Along with Inaugural Site in Greece, Now Accepting Patients for Post-Market Study of Flexivue Microlens™.

 

 

 

AMSTERDAM—(July 1, 2010)

Presbia, a leading medical device company that has developed a corneal inlay optical micro-lens solution for presbyopia, announced today that it has added two new post-market surveillance sites to track the progress of patients who have received the Flexivue Microlens™ solution for the treatment of the age-related loss of near vision.
Studio Oculistico Fantozzi Dot Marco in Marconi, Italy and Bogotá Laser Refractive Institute in Bogotá, Colombia join Presbia’s first post-market surveillance site located at the Institute of Vision and Optics at the University of Crete in Greece. In addition, all three post-market surveillance sites are currently accepting patients to receive the lens implantation and participate in these studies.
“I believe that the Flexivue Microlens™ is the best corneal inlay solution to treat presbyopia because there is an unquestionable need for a reversible procedure to treat this complex, age-advancing condition,” said Dr. Marco Fantozzi, Principal Investigator at Studio Osculistico Fantozzi Dot Marco. “I also prefer the Flexivue Microlens™ because the learning curve for the procedure is short, and lens removal only takes approximately one minute when a patient’s condition requires a change in prescription. I look forward to being a part of the exciting future of corneal inlay solutions, especially with the Flexivue Microlens™.”
“Presbia’s Flexivue Microlens™ is an excellent alternative to the surgical correction of presbyopia,” said Dr. Gustavo Tamayo, Principal Investigator at Bogotá Laser Refractive Institute and who also recently became a member of Presbia’s Medical Advisory Board. “I have performed the implantation of these inlays with a femtosecond laser without any problem, in a fast procedure under topical anesthesia. My results confirmed my initial impressions—this solution is safe, effective and most important of all, it is reversible. The fact that you can remove the lens without secondary effects is remarkable, and this allows the patient to exchange the lens when needed due to the advancing nature of his/her condition.”

About Presbia’s Flexivue Microlens™


Presbia’s Flexivue Microlens™ solution involves implanting a 3mm lens, approximately 15 microns in edge thickness, in the corneal stroma of the patient’s non-dominant eye. Using Presbia’s proprietary insertion tool, the lens is placed in a pocket created in the cornea by a femtosecond laser. The lens may stay in place permanently, or can be easily removed and/or replaced if the patient’s presbyopia advances and a stronger prescription is required. The less than 10-minute procedure requires no general anesthesia, and the patient’s visual recovery takes only a couple of days. Since the Flexivue Microlens™ solution utilizes standard equipment and requires minimal additional training, the procedure requires no significant capital investment by the surgeon’s practice.

An animated video of the procedure is available at www.presbia.com.

ABOUT PRESBIA

Presbia is a leading ophthalmic-device company focused on the development of solutions for presbyopia, the age-related loss of the ability to read or focus on near objects. Chief among these approaches is the Presbia Flexivue Microlens™, a 3mm-diameter lens implanted using femtosecond laser technology. Further information is available at www.presbia.com.

Contact: Theresa Matson
Tel: +1-323-860-9544
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Note: The Flexivue Microlens™ and related medical procedures are not available in the United States and have not been evaluated or approved by the U.S. Food and Drug Administration.

 

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