STAAR’s EVO Viva receives CE mark
European authorities granted STAAR Surgical approval to begin distributing the EVO+ Visian ICL with aspheric optic, according to a press release.
The device is being marketed as EVO Viva and will first be available through select doctors in Spain, Germany and Belgium. In the coming months, the implant will be available more widely in Europe and other markets that recognize the CE mark, the release said.
The ability of the lens to correct myopia and presbyopia was demonstrated in a multicenter, prospective clinical trial, with an improvement in near, intermediate and distance visual acuity without compromising vision quality.
The implant is for use in phakic eyes in patients 21 to 60 years old. It can also be used as a pseudophakic eye treatment in patients 21 years of age and older with monofocal IOLs with and without cylinder correction for the correction of myopia ranging from –0.5 D to –20 D at the spectacle plane and with an anterior chamber depth of 2.8 mm or greater.