Optilume® BPH Catheter System Achieves First-ever Success in Urotronic's Innovative Commercial Procedure
Urotronic, a medical device company based in Minnesota, is pioneering the use of drug-coated balloon technologies for interventional urology. They have recently announced a significant milestone - the world's first commercial procedure using the Optilume BPH® Catheter System to treat benign prostatic hyperplasia (BPH). The procedure was successful and allowed the patient to leave the clinic on the same day under conscious sedation.
The patient had been experiencing urinary symptoms caused by benign prostatic enlargement, and the Optilume BPH offered a suitable and minimally invasive treatment option to provide relief. This innovative technology is expected to improve the quality of life for many men suffering from lower urinary tract symptoms (LUTS) due to BPH.
The Optilume BPH system is a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation using a proprietary double-lobe balloon with localized delivery of paclitaxel for treating LUTS secondary to BPH. This approach does not involve heating, cutting, steaming, or implants, making it a safer option. It also preserves erectile and ejaculatory function while delivering immediate symptomatic and functional improvements. The procedure is well-tolerated and can be performed in an office or ambulatory setting.
Positive data from two clinical trials evaluating the effectiveness and durability of Optilume BPH in treating LUTS secondary to BPH were presented during the American Urological Association (AUA) annual meeting in Chicago. The PINNACLE trial's 12-month report showed a significant increase in average peak urinary flow rate (Qmax) compared to other randomized MIST trials for BPH. The EVEREST trial demonstrated the durability of symptom and flow rate improvement over a four-year follow-up period.