PARIS--(BUSINESS WIRE)--Pixium Vision (FR0011950641 – PIX) a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, announces today the first implant and successful activation of IRIS® II, the only epi-retinal implant with 150 electrodes, intended for patients who have lost sight as a result of retinitis pigmentosa (RP).
The first human implant of IRIS® II was successfully performed in January, by Professor Michel Weber, Head of Ophthalmology at the University Hospital of Nantes, France. This is part of Pixium Vision’s ongoing clinical trial to assess the safety and performance of IRIS® II as a treatment to compensate for blindness by providing a form of bionic vision and enabling greater autonomy for patients.
Professor Weber commented: “This first implant was successfully completed for the 58 year old retinitis pigmentosa patient. With the implant design and its smart retinal fixation, the procedure is close to the surgical techniques familiar to the retinal surgeons.” Pr. Weber added: “After many years in darkness, the patient was activated and reported first perception of light. Per clinical protocol, the patient will now enter training to learn how to interpret the light signals.”
The implant activation and first light perception provide tangible evidence of visual perception. It precedes the normal rehabilitation process where, per protocol, the patient learns to interpret the bionic vision.
Dr Yannick Le Mer, a pioneer in retinal implant surgery at the Fondation Ophtalmologique Rothschild in Paris (a centre of excellence for ophthalmic surgery participating in the study with Hôpital des Quinze-Vingts) added: “The new IRIS® II implant represents a major step forward for patients with retinitis pigmentosa: the intervention is relatively quick thanks to the design of the implant and it is now equipped with 150 electrodes, close to three time more than currently available. Epi-retinal approach is currently the less invasive and most optimal solution to allow retinitis pigmentosa patients to emerge from darkness.”
Khalid Ishaque, CEO of Pixium Vision, said: “The first implant and activation of IRIS® II, with its innovative features, is an exciting and major advance in the field of bionic vision development, interfacing the eye and the brain. Pixium Vision is dedicated to conceive, develop and bring meaningful bionic vision innovations to surgeons, enabling them to treat patients who have lost sight.”
Up to 10 patients will be included in the ongoing clinical trial in several specialized centres in Europe. In December 2015, Pixium Vision filed for CE mark. Subject to CE mark approval, IRIS® II should be commercially available around mid-2016.
IRIS® II clinical study –
http://www.pixium-vision.com/file_bdd/dynamic_content/file_pdf_pdf_en/1456272440_PixiumVision-IRISIIActivation-ENGFinal.pdf
Pixium Vision - www.pixium-vision.com
1 Retinal safety of near infrared radiation in photovoltaic restoration of sight: Biomedical Optics Express Vol. 7, Issue 1, pp. 13-21 (2016) •doi: 10.1364/BOE.7.000013 https://www.osapublishing.org/boe/abstract.cfm?uri=boe-7-1-13&origin=search
