ProVerum Limited, a medical device company focused on innovative, safe and effective solutions for treating benign prostatic hyperplasia (BPH), announced it has received FDA approval for its ProVee System for BPH.

The ProVee System is a next-generation prostatic urethral stent designed to gently open up the obstructed prostate and relieve lower urinary tract symptoms associated with BPH. It works without cutting, burning, tearing, or piercing of prostatic tissue, offering the potential for an improved safety profile and faster recovery compared to other interventions.    

FDA approval was supported by results from the ProVIDE study, a randomised, double-blind, sham-controlled trial evaluating the safety and effectiveness of the ProVee System in men with moderate-to-severe BPH. The study met all primary and secondary endpoints, demonstrating significant and durable symptom relief and improvements in urinary flow through 12 months. No device- or procedure-related serious adverse events were observed, no patients required catheterisation following the procedure, and sexual function was preserved throughout the follow-up period.