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A new three‐piece inflatable penile prosthesis was introduced in 2019. Named the Rigicon Infla10®, the new device has been implanted in 26 centres by 103 physicians. Clinical investigation for FDA approval in the United States will begin in late 2022. Data from Patient Information Forms (PIFs) submitted to the manufacturer were analyzed to summarize early outcomes. Most early Rigicon Infla10® IPPs performed before 1/2022 were included in this retrospective analysis of volunteered PIFs. These early results demonstrate initial durability from re‐operation equivalent to other contemporary devices.
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