Wednesday, July 19, 2023
Urotronic, a medical device company based in Minnesota, has announced the successful completion of the world's first commercial procedure using their Optilume BPH Catheter System to treat benign prostatic hyperplasia (BPH). The procedure was performed under conscious sedation, allowing the patient to leave the clinic on the same day. The patient had a history of urinary symptoms caused by benign prostatic enlargement, and the Optilume BPH Catheter System provided a suitable option for symptomatic and functional relief through a minimally invasive approach.
The Optilume BPH Catheter System is a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation with a proprietary double-lobe balloon and localized delivery of paclitaxel. This approach aims to achieve an anterior commissurotomy and maintain luminal patency during the healing process. Unlike other treatment methods that involve heating, cutting, steaming, or implants, Optilume BPH offers an alternative solution that delivers immediate symptomatic and functional improvements while preserving erectile and ejaculatory function. It is well-tolerated and can be performed in an office or ambulatory setting.
Positive results from two clinical trials evaluating the effectiveness and durability of Optilume BPH were recently presented at the American Urological Association (AUA) annual meeting. The trials demonstrated that Optilume BPH achieved significant improvement in peak urinary flow rate (Qmax) compared to other randomized MIST trials for BPH. The 12-month report from the PINNACLE trial showed a more than doubling of Qmax, from 8.9 mL/second at baseline to 19.0 mL/second after 12 months of treatment (+113%). The EVEREST trial also showed the durability of symptom and flow rate improvement over a four-year follow-up period.
