Pixium Vision releases 6-month update of Iris II epiretinal system
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Pixium Vision’s epiretinal Iris II system for outer retinal degeneration improves visual performance after 6 months, but a shorter device lifespan has been detected, according to a press release.
Clinical safety and performance data at 6 months demonstrated the device had a favorable safety profile, the release said. However, new implantations have been temporarily halted while the company validates corrective measures with regulatory bodies regarding the lifespan of the Iris II system.
In this set of study patients, a shorter than expected lifespan of the device was noticed. The exchangeable design of the Iris II allows it to be replaced, and one replacement was completed successfully.
Iris II has a CE mark for outer retinal degeneration, including retinitis pigmentosa.