A new three-piece inflatable penile prosthesis was introduced in 2019. Named the Rigicon Infla10®, the new device has been implanted in 26 centers by 103 physicians. Clinical investigation for FDA approval in the United States will begin in late 2022. Data from Patient Information Forms (PIF's) submitted to the manufacturer were analyzed to summarize early outcomes.
Retrospective review of PIF's from 319 patients implanted from 1/06/2019 to 12/31/2021 was performed to assess device durability and rates of reoperation for infection, mechanical failure, or medical reason.
Mean follow-up was 21.2 ± 11 months with a range of 5-36 months. Mean age was 58.5 ± 8.7 years. Of the total, 4.4% required removal or revision. Complications include mechanical failure (2.5%) and component migration (0.7%). There were no infections observed in this series. One patient (0.4%) required revision for inadequate straightening of Peyronie's Disease (PD). Three patients (0.9%) requested device removal for dissatisfaction. A total of 95.6% of Rigicon Infla10® was free from explant or revision 21 months from the original implant date. Kaplan Meier analysis revealed cumulative survival of the device at 12, 24, 36 months was 95.6%, 94.7% and 93.7% respectively.
The vast majority of the early Rigicon Infla10® IPP's performed prior to 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.
BJU international. 2023 Jan 12 [Epub ahead of print]
Steven K Wilson, Lexiaochuan Wen, Mariano Rossello, Pedro Maria, Rafael Carrion, Paul Perito, David Ralph, Gabriele Antonini, Alejandro Carvajal, Metin I Ozturk, Eric Chung
Dept. of Urology, Institute for Urologic Excellence, La Quinta, CA, USA., Dept. of Urology, Mayo Clinic, Rochester, MN, USA., Dept. of Andrology, Instituto Medico Rossello, Palma De Majorca & Madrid, Spain., Dept. of Urology, Montefiori Medical Center, Bronx, NY, USA., Dept. of Urology, University of South Florida, Tampa, FL, USA., Dept. of Urology, Perito Urology, Coral Gables, FL, USA., Dept. of Andrology, University College London Hospitals, London, England, U.K., Dept. of Andrology, Antonini Urology, Rome, Italy., Dept. of Urology, CES University, Medellin, Columbia., Dept. of Urology, University of Health Sciences, Haydarpaşa Training and Research Hospital, İstanbul, Turkey., Dept. of Andrology, AndroUrology Centre, Brisbane, Australia.