Zenflow Spring®
Relief Without Regrets
For many men, BPH treatment presents an unacceptable tradeoff. Medications are abandoned due to limited efficacy and side effects, and procedural options are often refused because of concerns about surgical trauma. As a result, patients delay care and practices miss critical opportunities to treat.
%201%20(1).avif)
Zenflow Spring is the new long-lasting BPH solution that patients say yes to.
For the first time, you can offer clinically-proven long-term BPH relief without the side effects of pills or the trauma of existing BPH procedures.
Designed at Stanford Biodesign, Zenflow Spring puts the patient experience first.
It’s the only system delivered through a fully flexible scope to support patient comfort, with three size options to help achieve a precise anatomical fit.
No piercing, cutting, heating, or tissue removal.
A well-tolerated procedure with only mild pain, similar to a flexible diagnostic cystoscopy.
99% of men did not need a post-procedure catheter.
0% surgical reintervention through 12 months.
Gentle by Design.
Confident in Delivery.
Reversible When It Matters.
Gentle by Design. Confident in Delivery. Reversible When It Matters.
Spring is a gentle, minimally-invasive procedure that fits seamlessly into multiple sites of service and most men recover in hours.
It’s the only solution with long-term comprehensive data supporting reduced risks of encrustation and migration that can occur with other BPH solutions.
Delivered with our balloon anchor that enables accurate and consistent implant delivery and the confidence of HD visualization during implant release.
A fully reversible BPH treatment, Spring can be safely and easily retrieved - providing patients peace of mind while preserving future treatment options if needed.
Zenflow’s Clinical Evidence
Spans 300+ Patients Over Multiple Years
Clinical trials conducted by top global urologists have shown a well-tolerated procedure with fast recovery, low rate of side effects, and durable results.
.svg)
PHASE I
Feasibility Study 10+ Patients
PHASE II
ZEST Pilot Study 80+ Patients
PHASE III
BREEZE Pivotal IDE Trial 200+ Patients
Key Data Highlights Supporting FDA Approval
The ZEST pilot study and BREEZE pivotal study supporting FDA approval demonstrated remarkable outcomes and met all primary safety and effectiveness endpoints in the intended use population. Highlights include:
Safety
Best-in-class safety outcomes demonstrating that 99% of men did not need a post-procedure catheter, with a 0% device or procedure-related Serious Adverse Event (SAE) rate.
Effectiveness
Responder rate was 62% at one year, with a mean International Prostate Symptom Score (IPSS) improvement of 37% (9 points) exceeding the pre-specified clinical success threshold of 30%.
Durability
0% surgical reintervention with over 3 years of proven safety and efficacy from pilot and pivotal studies. Data shows consistent symptom relief across all visits, a strong safety profile with low AE rates, and evidence that implants can be removed without complications.
Patient Satisfaction
71% of subjects agree that the Zenflow Spring Implant and Delivery System improved their urinary symptoms.
Sexual Health
No deterioration in sexual function, including erectile or ejaculatory function.
Spring: Clinically Proven Relief Without Regrets
Clinical trials conducted by top global urologists, including the BREEZE pivotal trial, have shown a well-tolerated procedure with fast recovery, low rate of side effects, and durable results.
9pt
Marked Improvement in Symptoms
(IPSS @ 1 year)
62%
Saw at least 30% symptom relief at one year
IPSS
100%
Sexual function preserved
0
Spring device or procedure-related serious adverse events
0%
Surgical reintervention
through 1 year
96%
Free from BPH
meds at one year
99%
Did not need a
post-procedure catheter
71%
Report Spring improved their urinary symptoms
%20(1).avif)
Innovative Research, Better Results
Dr. Claus Roehrborn
Dallas, USA
“The Zenflow Spring clinical trial data thus far demonstrates promising outcomes with respect to patient symptom relief, urinary flow rates, and preservation of sexual function. I am excited to be part of the rigorous clinical trial research program.”
Prof. Peter Gilling
Tauranga, New Zealand
“With its intuitive approach and self-expanding implant design, the Spring System meets the needs of patients who are seeking an effective, less-invasive BPH treatment.”
Dr. Dean Elterman
TORONTO, CANADA
“The Zenflow procedure is a patient-friendly BPH treatment option that eliminates the need to pierce, ablate, or remove prostatic tissue. Based on favorable initial clinical trial results, it has the promise of becoming a first-line therapy of choice.”