Germany’s Retina Implant AG has received European regulatory approval to begin offering its Alpha IMS implant for restoration of moderate sight in people blinded due to retinitis pigmentosa. The system essentially replaces the function of the retina, capturing light on a 3×3 mm wireless microchip that has a 1500 pixel resolution, and stimulating the optic nerve based on what the chip sees. The Alpha IMS doesn’t use an external camera, so looking around is done naturally with the eyes rather than the head, as in some systems.
Thirty six people have received the implant so far, and the latest study involving nine blind people showed that the system is a practical solution to restoring useful vision in select patients, as they were able to recognize numbers on doors, faces, and identify facial expressions.
From the company announcement:
Coordinating investigator and founding director of the Institute for Ophthalmic Research at the Centre for Ophthalmology of the University of Tuebingen, Professor Eberhart Zrenner, added: “After more than seven years of rigorous testing in 36 patients, we are pleased to have demonstrated the safety, reliability and tolerability of the Alpha IMS. It was a very rewarding and touching experience to see blind patients regain some vision that helped them to better master the activities of daily life. This is a landmark in our journey to address the needs of the RP patient community which has limited treatment options available.”
Commenting on the CE marking, David Head, CEO of RP Fighting Blindness, said: “This is an important milestone and we congratulate Retina Implant AG. The latest results from the multi-centre clinical trial have shown the impact that Retina Implant’s technology has made in enhancing the quality of life for people living with RP. It is important to note that currently these devices offer hope to RP patients who are now completely blind, they are not suitable for partially-sighted people.”
Here’s a patient with an Alpha IMS implant recognizing large letters placed in front of him:
Press release: Retina Implant AG’s Alpha IMS Wins CE Mark…