Article
Safety profile in the Argus® II Retinal Prosthesis System post-market patients (I)
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Authors
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Grégoire Cosendai
- Second Sight Medical Products, Sàrl, EPFL-PSE A, Lausanne, Switzerland
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Peter Walter
- Poliklinik für Augenheilkunde, Aachen
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Albert Augustin
- Städt.Klinikum Karlsruhe, Karlsruhe
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Bernd Kirchhof
- Universitätsklinikum Köln, Köln
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José-Alain Sahel
- Center Hospitalier National d’Ophtalmologie des Quinze-Vingt, Paris, France
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Lyndon da Cruz
- Moorfields Eye Hospital, London, United Kingdom
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Stanislao Rizzo
- Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
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Fernando Arevalo
- The King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia
| Published: | October 18, 2013 |
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Outline
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Purpose: The Argus II Retinal Prosthesis System (Argus II) is the first and only artificial retina approved for market use (2011 CE mark in Europe, 2013 US FDA approval) and has since been implanted in 22 patients blinded by Retinitis Pigmentosa in 7 surgical centers in Italy, Germany, Saudi Arabia, France, and the UK. A post-market surveillance study has been started with the purpose to evaluate the safety profile of the approved device during commercial use compared to that observed in the investigational clinical study.
Methods: Safety data has been collected from the day of surgery to March 2013, covering on average 7.5 months (median 5.6 months, range from 25 days to 16.9 months; 13.73 patient years) of exposure. Vigilance requirements have ensured complete capture of safety related events in all implanted patients, independently from their participation in the post market study. The demographic distribution is: 7 female and 14 male patients, average age 52.4 years (range 32.0–75.0 years); equally distributed between OD and OS eyes.
Results: No surgery-or device-related serious adverse events have occurred to date. Fifteen patients experienced no surgery- or device-related adverse events. The other seven 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 implant placement). The first 5 events resolved between the same day and 9 days with medical treatment; the last two are ongoing. Two patients experienced device-related non-serious adverse events in the post-operative phase: one instance of device induced headache at 3 months that was mitigated by adjustment of the device settings and one instance of macula edema which was present during 12 month clinical follow-up; both events are ongoing.
Conclusions: The first group of Argus II patients using the commercially available device demonstrates a safety profile that is at 7.5 months post implantation markedly better than that observed in the developmental phase of Argus II.
