This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.
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The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v5.0 and IPP-specific mapping.
Timeframe: 12 months
The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months.
Timeframe: 12 months