STAAR Surgical Company, a developer, manufacturer and marketer of minimally invasive refractive lenses that go inside the eye, today announced it has completed the first of several procedures to implant Visian® Implantable Collamer® Lens (ICL™) V4c design.
The Visian V4c, which received European CE Mark approval in April, was designed to optimize the flow of fluid within the eye. The CentraFLOW™ proprietary technology eliminates the need for a surgical YAG peripheral iridotomy procedure days before the ICL implant, which the company said provides a more comfortable, convenient ICL procedure overall.
Dr. Erik Mertens, medical director and founder of the Medipolis Eye Centre in Antwerp, Belgium, implanted the Visian ICL V4c model in five eyes last Friday. These are the first procedures in a broader plan for eight sites and 100 eyes before the company conducts a full market launch in countries that accept CE Mark approvals.
“The V4c design offers significant benefits,” Dr. Mertens stated in the press release. “Since the approval late last year of the expanded range ICL, I have implanted the ICL in patients with as low as -1.5 diopters of myopia. Based on this initial experience, the new V4c design has proven to be more comfortable and convenient for the patient, as well as for me and my staff. Eliminating the iridotomy step puts the ICL procedure on the same level of efficiency as LASIK and it provides as good, if not better, visual results for the patient. … This latest ICL development eliminates a step in the procedure, and I believe this revolutionary CentraFLOW™ technology will be a game changer for implant-based refractive surgery.”
The company said the purpose of the pre-marketing procedures is to establish a strong marketing platform for the full launch, which the company said showcased at the upcoming ESCRS meeting in Vienna during September.
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STAAR Surgical Co. (STAA) Completes First of Several Optical Procedures to Prepare for Full-Market Product Launch
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