Medical device company Zenflow has reported that its Spring System demonstrated durable benefits three years post-placement for individuals with benign prostatic hyperplasia (BPH) in the ZEST pilot studies.
According to the company, the device is setting up a new category of treatment called first-line interventional therapy (FIT), aiming to offer minimally invasive treatments with safety advantages and reversibility akin to medication.
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These studies showed that at the 36-month mark, individuals who received treatment with the Zenflow Spring exhibited a 46% improvement in their International Prostate Symptom Score (IPSS) compared to baseline.
BPH symptoms’ negative influence on quality of life (QOL) was found to be half that of at the baseline, and peak urinary flow rate (Qmax) increased significantly, with no decline in ejaculatory or erectile function observed over 36 months.
The studies included 72 participants and utilised IPSS and IPSS-QOL to measure symptom improvement. In addition, functional improvement was gauged by Qmax.
The calculation of overall effectiveness measures was done through a mixed model for repeated measures (MMRM) analysis.
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By GlobalDataSexual health was assessed using the Sexual Health Inventory for Men (SHIM) and the Male Sexual Health Questionnaire – Ejaculatory Domain (MSHQ-EjD).
Currently, the safety and effectiveness of the Spring System are under evaluation in the multi-centre, prospective, randomised BREEZE study in the US and Canada.
Zenflow is focused on enhancing treatment for individuals with urinary obstruction due to an enlarged prostate.
The system’s tiny spring-like coil design claims to improve the patient experience by opening the urethra gently while maintaining the natural anatomy.
It is still investigational and has not received approval for commercial use.
Zenflow CEO Shreya Mehta said: “We’re encouraged to see the three-year data build upon the strong efficacy and durability results we saw at two years, further underscoring the Zenflow Spring as a promising, much-needed alternative for BPH patients and urologists seeking FIT options.
“We look forward to sharing developments with the urology community as we move toward FDA approval and commercial launch.”
