Device profile of Optilume BPH Catheter System for minimally invasive treatment of benign prostatic hyperplasia

Benign Prostatic Hyperplasia (BPH) can lead to Lower Urinary Tract Symptoms (LUTS) that worsen with age and impact quality of life. Minimally invasive Surgical Therapies (MISTs) provide an alternative to medical and surgical interventions for the treatment of LUTS. The Optilume BPH Catheter System is a MIST for LUTS, which is the focus of this review.

The Optilume BPH Catheter System is a Food and Drug Administration (FDA)-approved MIST that utilizes balloon dilation and delivery of paclitaxel to the prostatic urethra to treat LUTS. This review evaluates the technology, utility, clinical evidence, safety profile, and long-term efficacy of Optilume BPH Catheter System, in the context of alternative options for management of LUTS. PubMed and Google Scholar were searched and all published articles and abstracts up to May 2025 related to Optilume BPH Catheter Systems were included in our review.

The Optilume BPH Catheter System is a promising MIST in the market with durable results and acceptable safety profile. Ongoing and future research will further refine its long-term safety and efficacy.