Survival From Revision Surgery for New Rigicon Infla10 Three-piece Inflatable Penile Prosthesis Is Comparable to Preceding Devices

Author(s): Steven K. Wilson, Hodo Haxhimolla, Boon Kua, Gerard Testa, Christopher Love, Mariano Rossello, Alejandro Carvajal, William Lynch, Muhammed A.M. Hammad, Martin Gross

JOURNAL

Gold Journal

YEAR

2023

DOI

https://doi.org/10.1016/j.urology.2023.06.031

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Abstract Short Summary

This study analyzed 535 Rigicon Infla10 implants from 15 countries to assess reoperation rates. The 3-year revision-free survival was 94%, showing comparable performance to established IPPs. Product: Infla10.

Abstract

Objective:

To evaluate the revision surgery rates and device survival of the Rigicon Infla10 inflatable penile prosthesis in a global cohort.

Key Findings:

Among 535 patients, only 3.5% required revision, mainly for mechanical failure (2.24%). The 3-year revision-free survival rate was 94%, comparable to competitor IPPs. Mechanical failures were primarily due to reservoir tubing leakage.

Conclusion:

The Rigicon Infla10 demonstrates high device survival and low revision rates, aligning with those of established devices, affirming its safety and durability.

Clinical Relevance:

The findings support Rigicon Infla10 as a reliable and safe option for ED patients, reassuring clinicians about its revision-free durability over a 3-year period.

Keywords

Infla10 penile prosthesis inflatable implant erectile dysfunction device survival revision rate mechanical failure urology

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