JUL 26, 2016
Pixum Vision’s epi-retinal implant, the IRIS II bionic vision system, now has CE approval for patients with vision loss from outer retinal degeneration.
The implant features a camera designed to mimic the human eye, with pixels that continuously capture light information from a visual scene and transmit the data to nerve fibers through a 150-electrode array secured to the retinal surface. The implant boasts almost 3 times the number of electrodes than Pixum’s previous version and it’s designed to be explanted for future replacements or upgrades.
The IRIS system is now available by prescription, and may qualify for national reimbursements within the European Economic Area.
A multicenter, open-label, non-randomized trial is currently underway in Europe. Subjects include patients with retinitis pigmentosa, Usher Syndrome, Cone-Rod dystrophy and choroidemia. Patients will be followed for a minimum of 18 months.
“The CE mark certification is a major step forward for Pixium Vision and for retinal dystrophy patients who have lost their sight, said Pixum Vision CEO Khalid Ishaque. “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.”
Pixum Vision is also developing a wireless, miniature subretinal implant, PRIMA, which demonstrated safety in an animal model earlier this year.