FDA approves first-line Zenflow system for the treatment of BPH

The FDA has approved the Zenflow Spring Implant and Delivery System for the treatment of symptoms associated with benign prostatic hyperplasia (BPH), Zenflow, Inc announced in a news release.¹

The first-line interventional therapy is designed to open the urethra “while preserving natural anatomy through a proprietary small spring-like implant,” the company said, which also noted that the therapy represents the first FDA-approved BPH treatment that is delivered in the outpatient setting via the Zenflow Spring Scope, which received FDA 510(k) clearance earlier this year.^1,2

“Today’s FDA approval marks the culmination of years of innovation,” said Shreya Mehta, CEO of Zenflow. “Urologists and patients alike have long sought a flexible, gentle solution that combines the reversibility of medication with the long-term durability of an interventional approach. For the first time, men living with BPH symptoms have a choice that offers relief without compromise. We are excited to bring this new therapy to market.”¹

In the news release, Zenflow pointed to data from the pivotal BREEZE study evaluating the Zenflow Spring Implant and Delivery System. The system was had a 60% responder rate vs a sham arm at 1 year, as well as a mean International Prostate Symptom Score (IPSS) improvement of 37%. It also yielded high patient satisfaction, with 71% of study participants saying they agreed with the statement that the system improved their urinary symptoms, and 66% saying they would recommend the system to others. The system also had safety outcomes the company described as “best in class”; 99% of patients did not require post-procedure catheterization. The overall related adverse event (AE) rate was 13%, and the serious AE rate was 0%. In addition, the investigators reported no deterioration in erectile or ejaculatory function.¹

The BREEZE study, which supported the FDA approval of Zenflow Spring Implant and Delivery System, was consistent with results from the ZEST studies presented earlier this year the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada. In those studies, patients receiving the Zenflow system had a 46% improvement in IPSS at 36 months relative to baseline (11.8 vs 22.0). In addition, the responder rate (proportion of subjects with ≥30% improvement in IPSS) was 74% at 36 months.³

“First-line interventional therapy with the Zenflow Spring Implant and Delivery System provides effective symptom relief with rapid recovery, minimal side effects, and preserved treatment adaptability,” said Dean Elterman, MD, associate professor at the University of Toronto and an attending urologist at the University Health Network in a news release from Zenflow. “The FDA’s approval of this novel treatment offers hope to men living with BPH because it simultaneously improves disruptive BPH symptoms while preserving sexual function.”¹

REFERENCES

1. FDA approves the Zenflow Spring Implant and Delivery System for first-line interventional therapy of patients with benign prostatic hyperplasia (BPH). News release. Zenflow, Inc. December 11, 2025. Accessed December 11, 2025. https://www.globenewswire.com/news-release/2025/12/11/3204336/0/en/FDA-Approves-the-Zenflow-Spring-Implant-and-Delivery-System-for-First-Line-Interventional-Therapy-of-Patients-with-Benign-Prostatic-Hyperplasia-BPH.html

2. Zenflow receives FDA 510(k) clearance for first-of-its-kind single-use cystoscope. News release. Zenflow. September 30, 2025. Accessed December 11, 2025. https://www.globenewswire.com/news-release/2025/09/30/3158543/0/en/Zenflow-Receives-FDA-510-k-Clearance-for-First-of-Its-Kind-Single-Use-Cystoscope.html

3. Three-year data of Zenflow’s Spring System demonstrate durability of clinical benefits for patients suffering from BPH. News release. Zenflow, Inc. April 26, 2025. Accessed December 11, 2025. https://www.globenewswire.com/news-release/2025/04/26/3068791/0/en/Three-Year-Data-of-Zenflow-s-Spring-System-Demonstrate-Durability-of-Clinical-Benefits-for-Patients-Suffering-from-BPH.html