Bionic vision system for people with vision loss from outer retinal degeneration CE approved

Pixium Vision announced that it has been awarded CE mark for its IRIS®II bionic vision system. This 150-electrode epi-retinal implant features a design intended to be explantable and upgradeable. The IRIS®II system is now CE mark approved for people with vision loss from outer retinal degeneration.



Christina Fasser, President of Retina International, an umbrella association of 33 national societies, said: “The progress in research with vision restoration of some visual perception is a reality, particularly with retinal prostheses. This research is addressing the growing patients’ expectations and their hope to regain some sight. On behalf of our member organisations, we are delighted to welcome the new bionic vision system IRIS®II that may offer people suffering from retinitis pigmentosa a new treatment option with a design that is intended to be explantable and upgradeable.”

The IRIS®II system is only available by medical prescription. Several leading ophthalmology centers in Europe are continuing to evaluate the system’s long-term performance based on a pre-defined protocol. The company is now able to file for national reimbursements.

Khalid Ishaque, CEO of Pixium Vision said: “The CE mark certification is a major step forward for Pixium Vision and for retinal dystrophy patients who have lost their sight. This recognition, by an independent expert body, validates the long-term multidisciplinary work that has resulted in market approval of the IRIS®II system. We will continue to develop our bionic vision systems with the aim to deliver improved visual perception and help retinal dystrophy patients lead more independent lives.”

In parallel, Pixium Vision is developing a tiny, wireless, sub-retinal photovoltaic implant for patients with AMD (age-related macular degeneration).

Product details can be found from Pixium Vision website.