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STAAR Surgical Visian ICLT Preloaded System Receives CE Mark Approval

Tue, 07/01/2014 - 9:38am
The Associated Press

STAAR Surgical Company, a leading developer, manufacturer and marketer of implantable lenses and delivery systems for the eye, announced that it has received CE Mark approval for its new Visian ICLT Preloaded System. The Preloaded ICL provides a number of benefits to both surgeons and their patients during the delivery of STAAR's Implantable Collamer Lens (ICL) into the eye. STAAR plans the official launch of the Preloaded System at the Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in London during September 2014. Preceding this meeting, key European refractive surgeons will utilize the technology in surgery to gain experience that will enable them to lead in podium activities during the ESCRS meeting.

The Preloaded ICL reduces overall procedure time; shortens the learning curve for new surgeons to perform ICL procedures and enables more consistent ICL lens delivery in the eye. New intellectual property developed by the STAAR R&D team has been incorporated into the Preloaded Injector design. Additional intellectual property includes a new hydrophilic coating technology, nanoCOATT, which allows for the smooth transition of the ICL through the injector system to the small incision for the ICL procedure.

The Preloaded ICL also includes an enhanced optic design that increases the useful optic zone size. This optic design may provide patients with the benefit of further enhanced quality of vision making the ICL even more competitive to LASIK. Depending on the ICL power the optical surface could increase up to 20%, potentially enhancing night vision. Each new advancement of the Visian ICL technology incorporates the previous improvements, so the highly successful Visian ICL CentraFLOW technology will also be utilized in the Preloaded ICL System.

"The new Visian Preloaded ICL is part of our rapid cadence of new products under development at STAAR," said Hans Blickensdoerfer, President of EMEA at STAAR Surgical. "This technology advancement is in response to feedback from surgeons to simplify the procedure by reducing the number of steps to deliver the ICL into the patient's eye. We believe the benefits that have been designed into Preloaded ICL will play a role in continued ICL market share expansion where approved. We anticipate a pricing premium for this technology advancement. CE Mark approval enables us to market the Preloaded in the European Union as well as other countries that recognize the CE Mark approval." "In the time and motion study done at our facility with the Visian ICL Preloaded System, lens preparation time was reduced by 68%," added Dr.

Erik Mertens, Medical Director and founder of the Medipolis Eye Centre in Antwerp, Belgium. "I look forward to the availability of the Visian ICL Preloaded System. I expect this system will increase the adoption of Visian ICL use, as well as add additional efficiencies and reproducibility to the implantation procedure"

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