FDA Approves the ProVee System – the First of a New Generation of Prostatic Urethral Stents for Treatment of BPH. ProVerum Limited, a medical device company focused on innovative, safe and effective solutions for treating benign prostatic hyperplasia (BPH), today announced it has received FDA approval for its ProVee® System for BPH. FDA approval was supported by results from the ProVIDE study, a randomized, 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 catheterization following the procedure, and sexual function was preserved throughout the follow-up period.
