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Second Sight Surpasses Major Milestone for Blind People with Retinitis Pigmentosa
50th and 51st Patients Worldwide implanted with Argus® Retinal Prosthesis;
Additional Procedures Planned across Europe and Elsewhere.
Lausanne, Switzerland, October 25, 2012. Prof. Stanislao Rizzo, vitreoretinal Surgeon and Director of U.O. Chirurgia Oftalmica, AOUP, Pisa, Italy, marked an important milestone last week when a patient blinded by Retinitis Pigmentosa (RP) was implanted with an Argus II Retinal Prosthesis (Argus II), becoming the 50th patient in the world to be implanted with sight restoring technology manufactured by Second Sight Medical Products Inc. The next day his colleague Prof. Albert Augustin, Augenklinik Karlsruhe, Germany, implanted the 51st device into a German patient.
“I am very proud to have been the surgeon that performed the milestone 50th implant,” said Prof. Rizzo, “Our patients are really grateful for this groundbreaking therapy as this gives them back more autonomy in their daily life”.
RP is a rare, hereditary disease that causes a progressive degeneration of the light-sensitive cells of the retina, leading to significant visual impairment and ultimately blindness, which until now was untreatable. Second Sight’s Argus II System employs electrical stimulation to bypass these defunct cells and stimulate remaining viable retinal cells to induce visual perception in blind individuals.
Prof. Rizzo added, “The results we have seen to date have gone way beyond any expectation that I had. Patients that previously had practically no residual vision, can now distinguish shapes, move around and eat more independently. This has an enormous emotional and functional impact on their quality of life. As well, the safety profile has been very strong and none of my seven patients have experienced a serious adverse event.”
The 51st patient was implanted by Prof. Augustin who said, “This is a great opportunity! For the first time in history we are re-establishing visual function in these blind patients.”
“The cooperation of hospitals all over Europe has been very gratifying”, said Gregoire Cosendai, PhD, Head of Europe for Second Sight. “Leading ophthalmologists are now aware of the meaningful benefit that Argus II offers their patients and are becoming proactive in advancing the therapy in their clinic. We will soon see additional procedures performed in other countries, both within and outside Europe.”
About the Second Sight Retinal Prosthesis System
The system works by converting video images captured by a miniature camera, housed in the patient’s glasses, into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. Patients then learn to interpret these visual patterns thereby regaining some visual function. Six of the first 50 patients were implanted with a first generation Argus I system, that was attached to an electronic implant inserted invasively in the skull behind the ear with a wire connecting to the eye under the skin. The last 45 patients have received the second generation Argus II system, which is much less invasive and is implanted only in and around the eye. Second Sight gained European approval (CE Mark) for the Argus II system in 2011 – the first and only approval of a retinal prosthesis anywhere in the world. In September 2012, a U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel unanimously voted 19-0 to recommend FDA approval, which is now pending.