Zenflow, Inc. released three-year data from its ZEST pilot studies, demonstrating sustained positive outcomes for patients using the Zenflow Spring System, a minimally invasive treatment for benign prostatic hyperplasia (BPH). The system, categorized as First-Line Interventional Therapy (FIT), offers a potentially reversible solution for BPH, unlike traditional surgical interventions. The data was presented at the 2025 American Urological Association meeting.
This long-term data is crucial for establishing the credibility and efficacy of the Zenflow Spring System within the evolving FIT landscape for BPH treatment. It addresses a critical need for minimally invasive, reversible BPH solutions, potentially shifting the treatment paradigm away from more invasive procedures and towards earlier intervention with FIT devices. This offers patients a more appealing alternative with a lower risk profile and the potential for improved quality of life.
Three years post-implantation, patients experienced a 46% improvement in IPSS scores, a key measure of BPH symptom severity. Quality of life measures also improved significantly, with the negative impact of BPH symptoms halved compared to baseline. Importantly, the study revealed sustained improvements in urinary flow rate and no adverse effects on sexual function. The consistent responder rate of approximately 70-75% across the three-year period further supports the device’s long-term effectiveness.
These positive three-year results solidify the Zenflow Spring System’s position as a leading contender in the emerging FIT category. The data strengthens the case for its potential to become a preferred treatment option for BPH, offering a more patient-friendly approach and potentially driving wider adoption of early intervention strategies for managing this common condition. The ongoing BREEZE™ study will further contribute to the body of evidence supporting the device’s safety and efficacy, paving the way for potential FDA approval and commercialization.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
