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Clinical trial results published in the journal Ophthalmology showed that blind patients with retinitis pigmentosa who received Second Sight Medical Products' (EYES +7.3%) Argus II Retinal Prosthesis System performed better three years post implantation.
- Of the 30 patients tested, 29 remained implanted with functioning Argus II systems three years after surgery. Improvements in visual function and orientation and mobility (O&M) were maintained during the follow-up period. Up to 89% of the patients performed statistically better with the Argus II versus native residual vision in visual function tasks at year 3. Up to 80% of the subjects received benefit from Argus II as measured by functional vision and patient-reported quality of life.
- The FDA approved the Argus II in February 2013 as a humanitarian device, a pathway that is limited to products that treat fewer than 4,000 Americans each year.