French retinal implant maker Pixium Vision said Monday it won CE Mark approval in the European Union for its Iris II bionic vision system designed for individuals with vision loss from outer retinal degeneration.
The Iris system is comprised of a retinal implant and a pair of camera-mounted glasses connected to a “pocket computer.” The computer processes images captured by the glasses and transmits the data into a signal that’s transferred back and projected onto the intraocular implant, where it stimulates the optic nerve and generates images that the brain learns to interpret as visual signals.
“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,” Retina International prez Christina Fasser said in a press release.
The Iris II system is a 150-electrode epi-retinal implant designed to be upgradeable and explantable, and integrates continuous image capture with “time independent pixels” and 3 times the number of electrodes than its previous version, Pixium 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,” CEO Khalid Ishaque said in a prepared statement.
In May, Pixium said it won U.K. Medicines & Healthcare products Regulatory Agency approval to initiate a clinical trial of its Iris II bionic vision system.
In February, Pixium announced the 1st implantation and successful activation of its Iris II epi-retinal implant designed for patients with vision loss as a result of retinitis pigmentosa.
The 1st implant took place in January and was performed by Michel Weber of France’s University Hospital of Nantes, the company said. Up to 10 patients are slated to be included in a clinical trial of the device, according to Pixium Vision.