ProVerum, a medical device company focused on solutions for treating benign prostatic hyperplasia (BPH), has announced it has received US Food and Drug Administration (FDA) approval for its ProVee system for BPH.
The ProVee system is a next-generation prostatic urethral stent designed to gently open 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.
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.
“The data from the ProVIDE clinical study are very impressive and make a strong case for the ProVee system to become a first-line interventional therapy to treat BPH,” said Steven A Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai (New York, USA) and global lead investigator for the study.
“FDA approval of the ProVee system marks a major step forward for ProVerum and for men living with BPH,” said Paul Bateman, chief executive officer of ProVerum. “With the ProVee system, urologists have a safe, effective and straightforward procedure that can deliver meaningful symptom relief and improvement in quality of life.”
