MILAN, September 6, 2012 /PRNewswire/ --
The New Treatment Pathway for Retinitis Pigmentosa
Second Sight Medical Products, Inc., the world's only developer and manufacturer of an approved retinal prosthesis for the blind, the Argus® II Retinal Prosthesis System (Argus II), is featuring an extensive program of symposia, presentations and posters at the 12th EURETINA Congress from 6-9 September 2012 in Milan, Italy. Several investigators from the leading eye hospitals in Europe will present nearly a dozen talks and posters over the four day event.
(Photo: http://photos.prnewswire.com/prnh/20120906/559510 )
Argus II is the first approved treatment for severe to profound outer retinal degeneration in the European Economic Area. The largest clinical trial of a retinal prosthesis to date demonstrates that the retinal prosthesis can reliably withstand long-term implant (> 5 years) while offering a positive benefit/safety profile. Subjects demonstrated clear improvements in visual function and report using Argus II in their daily lives and have shown that the system has a positive impact in their life (as measured by the Functional Low-vision Observer Rated Assessment (FLORA™)).
Perceiving Simultaneous Colors Using the Retinal Prosthesis System
Professor Paulo Stanga, Vitreoretinal Surgeon at Manchester Royal Eye Hospital and Director of the Manchester Vision Regeneration (MVR) Lab, United Kingdom, investigated whether subjects blinded by retinitis pigmentosa could consistently perceive different colors at the same time using Argus II.
Four blind patients fitted with Argus II were tested by Prof. Stanga. Different pairs of electrodes on the implanted electrode array were directly stimulated simultaneously with trains of electrical pulses at different frequencies and intensities. The patients reported perceiving color(s) after each stimulation demonstrating for the first time that patients blinded by outer retinal dystrophies are able to perceive simultaneous colors using the retinal prosthesis system. "Seven different color combinations were perceived by the subjects, though not all subjects saw all colors", said Prof Stanga. "Last year we showed that Argus II subjects could perceive colors, but now we have shown that they can perceive two colors at once. This data is encouraging because it suggests the possibility that Argus II will one day restore color vision."
Measuring the Functional Vision and Quality of Life With the Retinal Prosthesis System
As visual prostheses and other vision restoration treatments for completely blind patients become commercially available, there is a need for tools to assess the impact of these treatments on patients' functional vision and quality of life. "The FLORA measures the impact of the retinal prosthesis system", said Fatima Anaflous, Low Vision Therapist at Second Sight Medical Products. The FLORA was administered to 26 subjects in the Argus II clinical trial. Subjects had been implanted between 17 and 44 months at the time of the assessment. Results from the assessment are also set to be presented at the meeting.
"Personally, I have been amazed by the benefit that Argus II has provided for my patients," said Dr. Stanislao Rizzo, Vitreoretinal Surgeon and Director of U.O.Chirurgia Oftalmica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. "They use the device daily. Some use it for particular tasks, or in particular settings, while others use the system much more broadly. All of my patients have described the positive impact that it has had on their lives, and their excitement about things that they are relearning how to do after years of blindness. The most common comments I receive are about their improvements in orientation and mobility tasks, and how they feel more connected socially and environmentally. "
FDA Panel Scheduled to Review Second Sight's Argus II
An application for FDA market approval, based on the two year follow up of the 30 subjects in a clinical study, has been submitted and is under review by the Agency. A U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel has been scheduled to review the data presented in the Humanitarian Device Exemption (HDE) market approval application on September 28, 2012 in Gaithersburg, Maryland. If FDA market approval is granted, the Argus II system will become the first ever retinal prosthesis to gain approval in the U.S. The system became, and remains, the only approved retinal prosthesis anywhere in the world when it received CE Mark approval in Europe last year.
Second Sight Medical Products, Inc., located in Los AngelesCalifornia, was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations, such as Retinitis Pigmentosa. Through dedication and innovation, Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. European Headquarters are in Lausanne, Switzerland.Second Sight, Argus and the Second Sight logo are registered trademarks of Second Sight Medical Products, Inc. Argus II is not approved for commercial use in the United States; it is being used in clinical trials under an FDA-approved Investigational Device Exemption (IDE).
For more information please contact
Maura Arsiero (+41-21-693-91-01)
publicrelations@2-sight.com
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