Staar Surgical (NSDQ:STAA) said today that it won CE Mark approval in the European Union for its Visian ICL pre-loaded system, an implantable collamer lens designed as an alternative to Lasik surgery.
Monrovia, Calif.-based Staar said it plans to launch the pre-loaded Visian ICL at the Congress of the European Society of Cataract and Refractive Surgeons in London in September.
"The new Visian pre-loaded ICL is part of our rapid cadence of new products under development at STAAR," EMEA president Hans Blickensdoerfer said in prepared remarks. "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 pre-loaded 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 pre-loaded in the European Union as well as other countries that recognize the CE Mark approval."
Staar said the pre-loaded ICL includes its new hydrophilic coating technology, nanoCOAT, designed to smooth the transition of the lens through the injector system. It also includes an enhanced optic design that increases the useful optic zone size, according to a press release.
"In the time and motion study done at our facility with the Visian ICL pre-loaded system, lens preparation time was reduced by 68%," Dr. Erik Mertens, Medical Director and founder of the Medipolis Eye Centre in Antwerp, Belgium, said in a statement. "I look forward to the availability of the Visian ICL pre-loaded 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."