STAAR Surgical Company, a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, was notified yesterday of the approval of its EVO Visian ICL, STAAR's Implantable Collamer Lens, for distribution in Canada by the Medical Devices Bureau of Health Canada.
With extensive clinical experience globally, the EVO ICL is STAAR’s next-generation lens implanted in the eye that works with the patient’s natural eye to correct vision.
Unlike traditional contact lenses that are placed on the surface of the eye, the EVO ICL is positioned inside the eye between the iris and the natural lens where it stays indefinitely.
"We are very pleased with Health Canada’s approval that allows us to offer the EVO ICL for myopia, with a broad power range of -3.0 to -18.0 diopters, to our surgeons and their patients in Canada.
"This represents an important new treatment option for eligible patients between 21 and 45 years old living with nearsightedness. This approval reinforces our deep commitment to patients seeking visual freedom, as we continue to build our growing EVO ICL portfolio.
STAAR looks forward to bringing this visual freedom choice to the Canadian refractive surgery market," said Caren Mason, President and CEO.
The EVO ICL has an extensive clinical history of safety and effectiveness, as was recently reinforced at the American Society of Cataract and Refractive Surgery (ASCRS) Meeting earlier this month in New Orleans, Louisiana, as part of the Evolution of Visual Freedom™ initiative.
The EVO ICL, with its central hole, offers premium refractive outcomes with efficiency and comfort for both the patient and the surgeon by eliminating the extra surgical step of the peripheral iridotomy.
Approximately 200,000 lenses from the EVO ICL product family have been implanted globally to date. Clinical data show that the EVO ICL provides outstanding, predictable correction of high degrees 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