The IRIS®II bionic vision system (developed by Pixium Vision) recently received a CE Mark. This is European regulatory marking that means the product meets safety and reliability standards. Having this mark means that the IRIS®II can now be sold in Europe.
Also known as an artificial or bionic retina, the IRIS®II (Intelligent Retinal Implant System) and similar devices can be used in people with advanced retinal degenerations such as Retinitis Pigmentosa (RP) and age-related macular degeneration (AMD). In these conditions, the photoreceptor cells of the retina do not work as they are supposed to. However, the connection between the retina and the brain remains intact. This is because neuronal cells that send visual information to the brain and perform image processing are still present. The idea behind the retinal implant is to electrically stimulate these functional nerve cells to send visual information to the brain, bypassing the damaged photoreceptor cells.
The IRIS®II aims to provide the user with “useful selective visual perception” and is designed so that as upgrades or replacements become available, it can be removed and replaced. The device includes both internal and external parts. A video camera (mounted on a pair of glasses) is intended to mimic the functioning of the human eye by continuously capturing changes in a visual scene with its time independent pixels. A pocket computer, the size of a smartphone, then processes the captured image and transfers the signals to the retinal implant, a microchip array consisting of 150 micro-sized electrodes implanted on the surface of the retina (epi-retinal). To give perspective, each electrode is less than 100 micrometres in diameter, which is approximately the diameter of a human hair. Captured images sent to these electrodes are converted to electrical impulses, which can bypass the damaged photoreceptors to stimulate the remaining retinal nerve cells, transmitting the visual information to the brain.
Pixium Vision are striving to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater independence. Khalid Ishaque, CEO of this French company 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.”
The award of CE mark to the IRIS®II brings the number of such devices now available on the market to three. The other two devices are the Argus II (a retinal prosthesis system developed by Second Sight Medical Products) and the Alpha IMS (a subretinal implant developed by Retina Implant AG in Germany). These products received the European CE Mark in 2011 and 2013 respectively. The Argus II has also received marketing approval from the U.S. Food and Drug Administration (FDA). In addition, Pixium Vision is developing a second system called PRIMA. This tiny, wireless, subretinal implant for patients with AMD is currently in pre-clinical development and the company plans to launch clinical trials of PRIMA in Europe in 2016.
The possibility of restoring a form of vision using this technology and provide patients with a greater sense of autonomy is promising. Currently these devices are only offered to people with advanced retinal degenerations such as Retinitis Pigmentosa (RP), age-related macular degeneration (AMD) and choroideremia but may include other pathologies that cause sight loss in the future. These individuals had sight through childhood but are now completely visually impaired or have minimal light perception. Because the brain must interpret the devices signals, a person who has been visually impaired from birth would never have had the opportunity to develop this capacity and therefore be unlikely to benefit from the technology.
To date, visual function outcomes following implantation of these devices have been limited to perception of shapes and objects and basic navigation. Key to success of this process is the rehabilitation of patients. Individuals have to re-learn how to see and their brains need to learn how to interpret the new kind of information being received from the device. Retinal implant technology continues to evolve with scientists, ophthalmologists, mathematicians and physicists all working together to further optimise and improve on the capabilities of current and future retinal devices. Some of the challenges facing these experts include the development of a smaller implant device, compatibility with the curvature of the eye, a greater number of electrodes, more sophisticated data processing capabilities and increased resolution for facial recognition.
Central to this process is the interaction with patients who provide invaluable insight and feedback to developers into the performance of the device and how it may be adapted to improve day-to-day living. In this way, patients will actually become part of the validation and innovative stages, driving the development and optimisation of retinal implant devices and enabling them once again to perform tasks of ordinary day-to-day life. Fighting Blindness will continue to follow these developments closely and aim to keep you fully informed.
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