BlueWind Medical said that the two-year long OASIS study of its Revi System for the treatment of urgency urinary incontinence (UUI) has yielded positive results.
Revi System is a small, battery-free device implanted near the ankle during a single, minimally invasive outpatient procedure under local anaesthesia. Once activated, the device stimulates the posterior tibial nerve to provide relief from UUI.
The implant is said to be the first implantable Tibial NeuroModulation (iTNM) device for treating UUI, approved for use without prior failure of more conservative therapies.
It secured the US Food and Drug Administration (FDA) De Novo classification grant in August 2023.
The OASIS study is a multicentre, single-arm clinical trial involving 151 women with UUI and overactive bladder-wet syndrome (OAB-wet).
The study evaluated the safety and efficacy of the Revi System for treating UUI symptoms in patients with OAB-wet.
Primary endpoints were assessed at six and 12 months, with 97 participants completing the 24-month evaluation.
Key findings from the two-year mark show Revi System’s durable efficacy, positive safety profile, and high patient satisfaction, supporting its use for urgency urinary incontinence treatment.
The OASIS study’s two-year analysis showed that Revi System provided a sustained therapy response. As per the results, 79% of participants showed a ≥50% reduction in UUI episodes, and 56% achieved a ≥75% reduction.
In the second year, a flexible provider and patient-driven schedule (≥ two 30-minute sessions per week) led to sustained therapy responses, compared to year one.
High satisfaction rates were reported, with 97% of participants feeling ‘better’ to ‘very much better’.
Additionally, 28% of patients were dry on a three-day voiding diary. There was also a significant reduction in the large volume of urgency-related leaks.
Furthermore, the Revi System demonstrated an excellent safety profile, with no device- or procedure-related serious adverse events, migrations, or revisions.
Patients averaged one session on eight of 10 days, made to their specific symptom needs.
BlueWind Medical chief medical adviser Roger Dmochowski said: “The two-year study results affirm the Revi System’s significant impact in improving OAB and UUI symptoms and underscore its innovation and effectiveness as a minimally invasive neuromodulation option.
“Our commitment remains steadfast to enhancing treatment options and elevating the quality of life for people grappling with UUI.”
The medical technology firm said that there is an increased demand for flexible, non-pharmacologic treatment options with growing concerns about the potential link between anticholinergic agents and dementia risk.
