The PRIMA retinal implant system has received CE marking under European Union rules and may be marketed in 30 European countries, Science Corporation said.
Conformity was assessed by DEKRA, a notified body under the EU Medical Device Regulation. Commercial access will depend on clinic onboarding and reimbursement decisions in each country, with the first commercial implant expected in Germany.
PRIMA is intended for people with geographic atrophy caused by age-related macular degeneration. It restores functional central form vision for recognising letters, numbers and words, but does not restore normal natural sight or treat every form of blindness.
The 2×2mm photovoltaic implant is placed beneath the retina. Special glasses project near-infrared light onto the implant, which converts it into electrical stimulation of retinal cells.
A multicentre study enrolled 38 patients at 17 clinical sites in five countries. The average improvement after 12 months was 25.5 letters, equivalent to more than five lines on an ETDRS chart.
Eighty-four per cent of participants were able to read letters, numbers and words with the system. Eighty per cent achieved an improvement in prosthetic visual acuity of at least 0.2 logMAR, equivalent to ten ETDRS letters.
Average remaining natural vision did not deteriorate after the implant was placed beneath the atrophied macula. The company describes implantation as an outpatient procedure lasting about one hour.
PRIMA is not approved for sale in the United States. FDA Breakthrough Device and Humanitarian Use Device designations do not replace a separate market-review process.
