Outcomes from the pivotal OASIS study, published in the March 2025 issue of the Journal of Urology, highlighted high patient satisfaction and durability for the technology.
Park City, Utah-based BlueWind designed Revi for implantation near the ankle during a single outpatient procedure. Patients initiate Revi therapy at their convenience by placing a lightweight, wireless wearable around their ankle once daily. This provides stimulation to the posterior tibial nerve, offering relief from urgency urinary incontinence (UUI) symptoms.
The first and only FDA-cleared iTNM system activated by an external wireless wearable for patients with UUI, Revi enables patients to initiate therapy at their convenience.
A look at the study data from BlueWind
OASIS, a study of 151 adult women (mean age of 58.8 years), evaluated the efficacy and safety of Revi in treating UUI symptoms in patients with overactive bladder-wet syndrome (OAB-wet). Investigators assessed primary efficacy and safety endpoints at six and 12 months. Additionally, 97 patients consented to and completed the 24-month assessment.
Findings at two years demonstrated a sustained therapy response utilizing a more flexible provider and patient-driven schedule in year two. Patients averaged at least one treatment session on eight of 10 days, tailored to individual symptom needs.
BlueWind reports that 79% of patients had a 50% or greater reduction in UUI episodes. Additionally, 56% achieved a greater-than-or-equal-to 75% reduction in UUI.
The study saw high satisfaction rates, with 97% of participants satisfied. Investigators say 97% reported feeling “better” to “very much better.” Patients also saw freedom from leaks, with 28% of patients dry on a three-day voiding diary. They also reported a substantial reduction in large-volume urgency-related leaks (0.9 per day to 0.1 per day).
BlueWind said Revi had an excellent safety profile with zero device- or procedure-related serious adverse events. The study also saw no device migrations and no device revision procedures.
“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,” said Roger Dmochowski, M.D., Chief Medical Advisor, BlueWind Medical. “Our commitment remains steadfast to enhancing treatment options and elevating the quality of life for people grappling with UUI.”
