Outcomes demonstrated the safety and efficacy of the Spring implant and delivery system, which received FDA approval last year. Lead investigator Dr. Dean Elterman presented findings at the American Urological Association (AUA) annual meeting in Washington, D.C.
Zenflow designed its nitinol Spring implant and delivery system for the treatment of symptoms associated with BPH. The novel, first-line interventional therapy provides urologists with a minimally invasive option with demonstrated long-term durability and unique safety advantages. Those include no post-procedure catheterization and the ability to reverse treatment if desired.
Spring opens the urethra while preserving natural anatomy through a proprietary, small, spring-like implant. The company touts it as the only FDA-approved first-line interventional therapy in a range of lengths and diameters, allowing for patient personalization.
The superelastic nitinol device is implanted in an outpatient procedure using the company’s FDA-cleared Spring scope, a single-use, flexible cystoscope. Zenflow says that Spring, unlike other BPH interventions, eliminates burning, cutting, piercing or resecting tissue. The system’s unique design also offers complete reversibility.
BREEZE met all primary safety and effectiveness endpoints in its intended use population. It recorded a responder rate of 60% at one year, compared to 33% in the sham group. Mean international Prostate Symptom Score (IPSS) improvement came in at 37%, exceeding the pre-specified clinical success threshold of 30%.
The study also reported best-in-class safety outcomes demonstrating that 99% of men did not need a post-procedure catheter. It also saw a 0% device-related serious adverse event rate and an overall adverse event rate of 13%.
Commentary from Zenflow officials and investigators
Shreya Mehta, CEO of Zenflow, said:
“With the recent approval, presenting our pivotal data on the main stage at AUA provided an important opportunity to communicate directly with urologists about how the Zenflow Spring provides a flexible, gentle solution that combines immediate efficacy with long term durability, and the ability to reverse the procedure, if ever needed. We’re excited to introduce the Zenflow Spring to urologists and their patients seeking a long-term solution that avoids previous barriers to treatment, such as fears of surgery, concerns about sexual performance, and need for post-operative catheterization.”
Dr. Elterman added:
“The growing body of evidence behind the Zenflow Spring implant and delivery system—from the 12-month BREEZE pivotal trial data we presented at AUA to the 3-year follow-up from the ZEST pilot studies—makes a compelling case for its role in BPH care. This is a first-line interventional therapy that delivers meaningful symptom relief with rapid recovery, minimal side effects, and the flexibility to preserve future treatment options for patients.”
