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European post-market surveillance study results for the argus II retinal prosthesis system

Session Details

Session Title: New Drug Treatment

Session Date/Time: Saturday 13/09/2014 | 14:30-16:30

Paper Time: 15:02

Venue: Boulevard F

First Author: : M.Arsiero SWITZERLAND

Co Author(s): :    S. Rizzo   P. Walter   B. Kirchhof   A. Augustin   S. Grisanti   G. Richard

Abstract Details

Purpose:

The Argus II Retinal Prosthesis System (Argus II) was the first artificial retina approved for market use in Europe (2011 CE mark) and the only retinal prosthesis available in the United States (FDA approval in 2013). Safety and performance results are being followed in a European post-market surveillance study.

Setting:

As of February 20, 2014, 40 commercial patients with severe to profound retinitis pigmentosa have been implanted with the Argus II System in Italy, Germany, France, the Netherlands, the UK, and Saudi Arabia.

Methods:

Safety data – the number, type, and severity of adverse events – have been collected from the day of surgery to the present. Vigilance requirements have ensured complete capture of all significant safety related events in all implanted patients, independently from their participation in the post-market study. Therefore, safety data for all commercial patients will be reported here. Performance is measured in the post-market study by comparing subjects’ abilities to locate a high-contrast square on a black screen (Square Localization), determine the direction of a moving white bar (Direction of Motion), and determine the orientation of black and white bars shown for only 5 seconds (Grating Visual Acuity).

Results:

Of the 40 patients implanted, twenty-seven enrolled in the post-market study; four of these later withdrew. Of the study subjects, 17 were male and 10 were female. The average age at implant was 54 years (range 31-75). Three patients (out of 40 implanted) have experienced serious adverse events that required surgical intervention(s) to treat: one patient had recurrent conjunctival erosion; the second had recurrent hypotony and associated retinal detachment; and the third had hypotony. There were also 29 non-serious adverse events (AEs) among 11 subjects. Twenty-nine subjects had no adverse events. These results represent an improvement in the safety profile of the Argus II System, compared with that observed in the clinical trial. Results from Square Localization and Direction of Motion show that, as a group, subjects perform better with the System ON than with it OFF at most time points, with no performance decline over time (up to 12 months post-implant). Grating Visual Acuity, the most difficult of the tests, shows no major change in the implanted eye with the System ON vs. OFF.

Conclusions:

Results from the first group of Argus II patients using the commercially available device indicate a good safety profile and improved performance with the System ON compared to System OFF.

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