First commercial procedures performed with Zenflow Spring for BPH

The Zenflow Spring Implant and Delivery System, a removable nitinol prostatic urethral implant, is now being used commercially in the US following its FDA approval in December 2025.¹

The device is indicated for men with obstructive lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) who have prostatic urethral lengths of 25 to 45 mm and prostate volumes of 25 to 80 cc.² Zenflow, Inc, announced that the first commercial procedures had been performed across 4 centers, with the first procedure conducted July 29 by Sijo J. Parekattil, MD, FACS, in Winter Garden, Florida.

“It is very exciting that we can now offer patients a truly innovative treatment solution that will bring meaningful symptom relief and improve their quality of life,” said Parekattil, founder and president of Avant Concierge Urology and a clinical associate professor at the Orlando College of Osteopathic Medicine,in the news release.¹ “What’s notable for providers is that the steerable cystoscope system provides us the ability to assess the bladder and urethra before and after Spring placement, and the balloon anchoring system provides consistent and accurate Spring deployment. For patients, men can experience noticeable symptom relief almost as soon as they leave and typically avoid the discomfort of post-procedural catheterization. These and other factors combined make for a remarkable treatment option that we’re excited to offer at Avant Concierge Urology to men in our community living with BPH.”

Zenflow also reported that Bilal Chughtai, MD, of The Smith Institute of Urology/Northwell Health; Mohamed Bidair, MD, of Alvarado La Mesa Urology/San Diego Clinical Trials; and Austen Slade, MD, of Dr. Slade Urology recently performed their first Zenflow Spring procedures at centers in New York, California, and Idaho, respectively.

Data on the Zenflow Spring System

The approval of the Zenflow Spring System was supported by data from the BREEZE trial, a prospective, multicenter, multinational, randomized, single-blinded, sham-controlled study that evaluated the device in men with symptomatic BPH. Data from the study were presented at the 2026 American Urological Association Annual Meeting in Washington, DC.³

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

The BREEZE trial enrolled 205 male patients who were randomly assigned 2:1 to Spring implantation (n = 137) or a sham procedure (n = 68). Participants were at least 45 years old and had symptomatic LUTS associated with BPH and baseline International Prostate Symptom Score (IPSS) of at least 13.

The study's co-primary efficacy end points were the proportion of patients achieving at least a 30% improvement in IPSS at 3 months and the mean percentage change in IPSS at 12 months. The co-primary safety end points were the rate of extended post-operative urinary catheterization (more than 7 days from treatment) for inability to void and the incidence of device- or procedure-related serious adverse events (AEs) through 12 months.

At 3 months, 59.6% of patients in the Spring group and 33.3% of those in the sham group achieved at least a 30% IPSS improvement (P = .001). At 12 months, mean IPSS improvement was 37.2% (95% CI, 31 to -43.4), which the authors noted, “exceed[ed] the pre-specified clinical success threshold of 30% (P = .012).”

In total, 13% of patients experienced a device- or procedure-related AE. There were no device- or procedure-related serious AEs through 12 months of follow-up, and 99% of patients did not require post-procedure catheterization. Approximately 98% of patients remained implanted at 12 months.

REFERENCES

1. Zenflow announces U.S. commercialization progress with four centers completing Zenflow Spring® Implant and Delivery System procedures. News release. Zenflow. September 8, 2026. Accessed September 8, 2026. https://www.globenewswire.com/news-release/2026/09/08/3357601/0/en/zenflow-announces-u-s-commercialization-progress-with-four-centers-completing-zenflow-spring-implant-and-delivery-system-procedures.html

2. Instructions for use. Accessed September 8, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250007D.pdf

3. 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