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Robert Greenberg, Peter Walter, Albert Augustin, Bernd Kirchhof, Lyndon daCruz, Hannah Schimitzek, Gernot Roessler, Stanislao Rizzo; Argus® II Retinal Prosthesis System safety profile in post-market patients. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1040.
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The Argus II Retinal Prosthesis System (Argus II) is the first and only artificial retina approved for market use (2011 CE mark in Europe, US FDA approval pending) and has since been implanted in 16 severely vision impaired retinitis pigmentosa patients in 5 surgical centers in Italy, Germany and the UK. A post-market surveillance study has been initiated with the purpose to evaluate the safety profile of the approved device during commercial use compared to that observed in the investigational clinical study.
Safety data has been collected from the day of surgery to early December 2012, covering on average 6.2 months (median 6.6 months, range from 2 days to 13.3 months; 8.2 patient years) of exposure. Vigilance requirements have ensured complete capture of all safety related events in all implanted patients, independently from their participation in the post market study. The demographic distribution is: 6 female and 10 male patients, average age 50.8 years (range 31.0 - 74.0 years); 9 OD and 7 OS implanted eyes.
No surgical procedure or device-related serious adverse event has occurred to date.Ten patients experienced no surgery- or device-related adverse events. The other six patients experienced 7 surgery related non-serious adverse events, which occurred between the day of surgery up to 1 month post operatively: two instances of IOP elevation, and one each of nausea, vomiting, fainting, conjunctival irritation, and retinal tear (occurred during surgery when a retinal membrane was peeled prior to placing the implant). The first 5 events resolved between the same day and 9 days with medical treatment; the last two are ongoing. One patient also experienced device induced headache that is mitigated by adjustment of the device settings.
The first group of Argus II patients using the commercially available device demonstrates a safety profile that is at 6 months post implantation markedly better than that observed in the developmental phase of Argus II.
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