FDA grants 510(k) clearance to Urocross Expander System for BPH-related LUTS

On March 16, 2026, Prodeon Medical announced FDA 510(k) clearance for the Urocross Expander System, a novel, non-permanent implant technology for the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).¹

The Urocross System is delivered through a flexible cystoscope to remodel the obstructed prostatic tissue. The implant remains in place for up to 6 months before being retrieved. According to Prodeon Medical, the device is intended to provide minimally invasive symptom relief while preserving future diagnostic and therapeutic options.

“BPH is not solely a prostate condition; it is a bladder health issue,” said Kevin T. McVary, MD, professor of urology at Loyola University Medical Center, and co-principal investigator of the pivotal Expander-2 trial. “Delaying intervention may contribute to irreversible bladder changes over time. New interventional technologies like Urocross enable minimally invasive approaches without permanent implants, providing safe and effective symptom relief with rapid recovery while preserving sexual function. These type of innovations might lower the threshold for patients to seek early intervention and represents a meaningful evolution in BPH care.”

The 510(k) clearance was supported by data from the Expander-1 feasibility trial (NCT03758222) and the Expander-2 pivotal trial (NCT05400980). Expander-2 was a multicenter randomized controlled study evaluating the safety and efficacy of the device in men with LUTS associated with BPH. The study enrolled 240 patients across 23 sites in the US and Canada. Patients were randomly assigned 2:1 to the Urocross procedure or the control arm (cystoscopy only).

To be eligible for enrollment, patients needed to have a prostate volume of 30 to 80 cc and symptomatic BPH, defined as having an International Prostate Symptom Score (IPSS) of 13 or higher, a Qmax of 12 mL/sec or lower on a voided volume of at least 125 mL, and a post-void residual less than 250 mL. The primary end points were the rate of extended post-operative urinary catheterization and the change in IPSS from baseline to 3 months post-procedure.²

In the pivotal trial, investigators reported a mean improvement in IPSS of 48.1% at 12 months following implantation, corresponding to 6 months after device retrieval. The procedural responder rate—defined by the FDA as at least a 30% improvement in IPSS at 12 months—was 74.5%.

There have been no device- or procedure-related serious adverse events in the treatment arm to date. Sexual function was also preserved, with no cases of de novo sustained erectile or ejaculatory dysfunction reported. The procedure was described as having tolerability comparable to diagnostic flexible cystoscopy.

Final study completion is expected in December 2028.²

“BPH management is not a singular intervention; it is a journey with longitudinal commitment to the patient’s evolving quality of life,” added Daniel B. Rukstalis, MD, chair of urology at St. Catherine Hospital, Catholic Health System and co-principal investigator of the Expander-2 trial.¹ “As minimally invasive options continue to expand, the clinical conversation is increasingly focused on how we balance clinical efficacy with long-term patient satisfaction. Technologies like Urocross that avoid permanent implants preserving future treatment options are becoming increasingly relevant in clinical decision-making of chronic diseases and well positioned as one of the first-line interventional therapy for BPH even before medications.”

REFERENCES

1. Prodeon Medical receives FDA 510(k) clearance for the Urocross® Expander System, a novel non-permanent retrievable implant for treating urinary symptoms associated with benign prostatic hyperplasia. News release. Prodeon Medical. March 16, 2026. Accessed March 16, 2026. https://www.globenewswire.com/news-release/2026/03/16/3256258/0/en/Prodeon-Medical-Receives-FDA-510-k-Clearance-for-the-Urocross-Expander-System-a-Novel-Non-Permanent-Retrievable-Implant-for-Treating-Urinary-Symptoms-Associated-with-Benign-Prostat.html

2. Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath. ClinicalTrials.gov. Last updated April 9, 2025. Accessed March 16, 2026. https://clinicaltrials.gov/study/NCT05400980