A retinal implant called PRIMA has received approval for use in Europe, marking the first time such a device has been cleared anywhere in the world. The system, developed by Science Corporation, restores central vision in people with geographic atrophy, a form of age-related macular degeneration.
The PRIMA implant is inserted beneath the retina and works with a pair of glasses fitted with a camera. The glasses capture images and project them onto the implant using near-infrared light, which the device's chips convert into electrical signals that stimulate bipolar cells in the retina.
In a small study published last October, the system improved visual acuity in about 80 percent of participants. Patients reached an average of 20/160 vision, moving from the legal blindness threshold of 20/200 to a level that allows reading and recognizing faces.
The device has received a CE certification mark under the European Union Medical Device Regulation, allowing its use in the European Union and the United Kingdom. It has also been granted Breakthrough Device and Humanitarian Use Device designations by the US Food and Drug Administration.
The first commercial procedures are scheduled to begin soon in Germany, with rollout in the United Kingdom planned for later this year. Company executives say additional sites are being prepared and surgeons have already been trained.
