Dean Elterman, MD, highlights efficacy and safety data on the Zenflow Prostatic Spring

In the following interview, Dean Elterman, MD, MSc, FRCSC, discusses findings from the pivotal BREEZE trial (NCT04987138), which demonstrated that the Zenflow Prostatic Spring significantly improved lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) while demonstrating a favorable safety and tolerability profile.¹ These results were presented at the 2026 American Urological Association Annual Meeting in Washington, DC.

The Zenflow Spring System represents a new generation of prostate stents, also referred to as first-line interventional therapies (FITs), designed to provide a minimally invasive treatment option for men with BPH-related LUTS. Building on earlier clinical experience from the ZEST trial program, the BREEZE study was conducted as the pivotal North American trial that supported FDA approval of the system in December 2025. The device consists of a nitinol spring coil that is deployed within the prostate using a proprietary flexible delivery system, where it expands to relieve obstruction and improve urinary flow.

BREEZE was a prospective, randomized, sham-controlled study designed to evaluate the safety and efficacy of the Zenflow Spring System. Investigators enrolled 205 patients who were randomly assigned 2:1 to receive either the Zenflow implant (n = 137) or a sham procedure (n = 68). Key efficacy end points included the proportion of patients achieving at least a 30% improvement in International Prostate Symptom Score (IPSS) at 3 months and the percentage change in IPSS from baseline at 12 months. Safety assessments focused on extended postoperative catheterization and device- or procedure-related adverse events.

According to Elterman, the study demonstrated high procedural success, with the device successfully implanted in 99.3% of cases across a range of treatment settings, including office-based, ambulatory surgery center, and hospital environments. In the modified intent-to-treat population, 59.6% of patients treated with the Zenflow Spring achieved at least a 30% improvement in IPSS at 3 months compared with 33.3% of patients in the sham arm (P = .001). The treatment arm also exceeded the prespecified threshold for clinically meaningful symptom improvement at 12 months, with a mean percent change in IPSS of 37.2% (P = .012). The safety profile was favorable, with no extended post-operative catheterizations, no device- or procedure-related serious adverse events, and low reported pain scores, supporting the procedure's tolerability through 1 year of follow-up.

REFERENCE

1. Elterman D, Kalota S, Wright A, et al. EFFICACY AND SAFETY OF ZENFLOW PROSTATIC SPRING FOR TREATMENT OF LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC HYPERPLASIA; RESULTS FROM A PIVOTAL IDE CLINICAL TRIAL. J Urol. 2026;215(5S2):e5. doi:10.1097/01.JU.0001192572.07890.f8.10