Categories: CE MARK

STAAR Surgical Announces CE Mark Approval for the EVO+ Visian ICL with Aspheric (EDOF) Optic

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STAAR Surgical Company, a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, has received CE Mark for its EVO+ Visian ICL™ with Aspheric (EDOF) Optic, for commercialization in the European Union from its Notified Body, DEKRA.

STAAR Surgical notes the EVO+ Visian ICL with Aspheric (EDOF) Optic is STAAR’s next-generation lens. The lens is surgically implanted and works in harmony with the patient’s eye to correct vision.  Unlike traditional contact lenses that are placed on the surface of the eye, the EVO Visian ICL family of lenses is positioned inside the eye between the iris and the natural lens where it stays indefinitely.

The EVO+ Visian ICL with Aspheric (EDOF) Optic is indicated for the correction or reduction of hyperopia and myopia between +3.0 diopters and -18.0 diopters. These lenses  include CentraFLOW® technology, a central port that allows the flow of aqueous humor, thus eliminating the need for peripheral iridotomies.

The EVO Visian ICL family of lenses offers premium refractive outcomes with efficiency and comfort for both the patient and the surgeon.  Approximately 285,000 lenses from the EVO Visian ICL product family have been implanted globally to date.  Clinical data show that the EVO Visian ICL provides outstanding, predictable correction of a broad range of refractive errors, with the vast majority of patients achieving and maintaining 20/20 or better visual acuity through five years of follow up.1 Review of the peer-reviewed published literature demonstrates an excellent safety profile: specifically, eight studies, including data from 1,291 eyes followed for up to five years, describe a zero incidence of significant complications.2

Caren Mason, President and CEO, notes, “We are very pleased with the CE Mark approval for the EVO+ Visian ICL with Aspheric (EDOF) Optic. We plan to introduce this lens to a select group of surgeons for Early Effectiveness Observational use. This beta analysis is designed to elicit surgeon feedback on their experience with the EVO+ Visian ICL with Aspheric (EDOF) Optic including overall performance, patient acceptance, and practice development.  This represents an important new treatment option for eligible patients between 21 and 45 years of age living with nearsightedness or farsightedness.  This approval reinforces our deep commitment to patients seeking visual freedom, as we continue to build our growing EVO Visian ICL portfolio,” concluded Caren.

Clinical Trial for Presbyopic EVO+ Visian ICL Beginning this Year

As reported recently, the first-in-man clinical trial for the EVO+ Visian ICL lens designed for the correction or reduction of presbyopia is underway and continues to be promising.  “Earlier this week, we hosted leading global surgeons at our new STAAR Technology Center, sharing the science behind our Collamer material technology and early findings of our Presbyopic initial clinical trial.  The surgeons were pleased with this investigational use only preview and impressed with the data.  Later this year, we plan to initiate the pivotal clinical trial supporting the applications for the new EVO+ Visian ICL for correction or reduction of presbyopia,” added Ms. Mason.

1. Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism. Medicine. 2016 Apr;95(14):e3270.
2. Packer M.  Meta-Analysis and Review: Effectiveness, Safety and Central Port Design of the Intraocular Collamer Lens (ICL).  Clinical Ophthalmology, 2016;10;1059-1077.