Urocross Expander System enters US commercial use for symptomatic BPH

The first commercial procedure using the Urocross Expander System has been performed in the US, Prodeon Medical announced.¹

Urocross is a non-permanent implant that received FDA clearance in March 2026 for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The device is placed in the prostatic urethra through a flexible cystoscope and is designed to remain in place for 6 months before retrieval.

The first commercial procedure was performed by Tyler McClintock, MD, at The Hospital at Westlake Medical Center in Austin, Texas. The company reported that the procedure marks the beginning of a controlled US commercial release.

"What distinguishes Urocross is its design intent: it's placed through a flexible cystoscope, remodels the prostatic urethra over 6 months, and is then retrieved—leaving nothing permanent behind and preserving future diagnostic and treatment options," said McClintock, in the news release.¹ "In the pivotal trial, symptom improvement continued after the device was removed, and sexual function was not adversely affected. That combination makes Urocross a compelling addition to the therapies we can offer men seeking meaningful relief from LUTS associated with BPH."

Data on the Urocross Expander System

The efficacy and safety of the Urocross Expander System was assessed in the pivotal Expander-2 trial (NCT05400980). Expander-2 was a prospective, multicenter, randomized, blinded, sham-controlled trial enrolling 240 men with symptomatic BPH across 23 sites in the US and Canada.² Participants were randomly assigned 2:1 to Urocross implantation or sham flexible cystoscopy.

The study included men aged 45 years or older with an International Prostate Symptom Score (IPSS) of at least 13. The implant was intended to remain in place for 6 months, with follow-up planned through 3 years after retrieval.

The trial's primary safety end point was the rate of extended postoperative catheterization, defined as catheterization lasting more than 7 days because of an inability to void. The primary efficacy end point was the change in IPSS from baseline to 3 months post-procedure.

Interim results presented at the 2026 American Urological Association Annual Meeting showed a mean IPSS reduction of 8.2 points, or 32.0%, at 6 months in the Urocross group.

Investigators reported additional symptom improvement after device retrieval. The mean IPSS improvement reached 11.3 points at 7 months (-45.2%; n=146) and 12.0 points at 12 months (-49.0%; n=133), 10 points at 18 months, (-40.6%; n=88), and 13.2 points at 30 months (-56.8%; n=19). Approximately 74% of treated patients achieved at least a 30% improvement in IPSS at 12 months.

Investigators also reported stable erectile (16.0 at baseline vs 17.7 at 1 year; P =.006) and ejaculatory function (8.2 at baseline vs 10.1 at 1 year; P < .0001) throughout follow-up.⁴

Regarding safety, extended catheterization occurred in 0.6% of patients after implantation and 2.5% after retrieval. Treatment-related adverse events occurred in 36.9% of patients after implant and in 18.8% of patients after retrieval (0 to 30 days). Most adverse events were classified as Clavien-Dindo grade 1 or 2. No device- or procedure-related serious adverse events were reported.

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REFERENCES

1. Prodeon Medical announces first commercial case of the Urocross® Expander System. News release. Prodeon Medical. October 14, 2026. Accessed October 14, 2026. https://www.globenewswire.com/news-release/2026/10/14/3380731/0/en/prodeon-medical-announces-first-commercial-case-of-the-urocross-expander-system.html

2. Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath. ClinicalTrials.gov. Last updated September 24, 2026. Accessed October 14, 2026. https://clinicaltrials.gov/study/NCT05400980

3. McVary KT, Rukstalis D; Expander-2 Investigators. A pivotal, randomized, sham-controlled trial of the Urocross Expander system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia: 30 month safety and durability interim results from the Expander-2 trial. J Urol. 2026;215(5S2):e6. doi:10.1097/01.JU.0001192572.07890.f8.12

4. Prodeon Medical highlights the Urocross Expander System clinical results at the American Urological Association (AUA) 2026 Annual Meeting. News release. Prodeon Medical. April 28, 2026. Accessed October 14, 2026. https://www.globenewswire.com/news-release/2026/04/28/3282667/0/en/prodeon-medical-highlights-the-urocross-expander-system-clinical-results-at-the-american-urological-association-aua-2026-annual-meeting.html