Dr. Roger Dmochowski, the Salt Lake City-based company’s chief medical officer, presented the findings from the OASIS study at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) 2026 Winter Meeting. Data confirmed Revi’s sustained efficacy, safety and patient satisfaction in treating urge urinary incontinence (UUI).
BlueWind’s results come on the heels of Medtronic’s own positive study findings for an ITNM system that treats UUI. Medtronic won FDA approval for its Altaviva system in September 2025, while BlueWind’s Revi won its first de novo nod in 2023. It has since won expanded FDA approval, getting the green light for an enhanced device in December 2025.
Revi was designed 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 UUI symptoms. Altaviva, comparatively, gets activated before a patient goes home. It requires no daily intervention or manual adjustments from the patient.
More on the study data from BlueWind Medical
BlueWind said the data from OASIS reinforces Revi’s “position as the most clinically validated ITNM therapy for UUI currently available.”
The prospective, single-arm, open-label study involves 151 adult women with UUI at a mean age of 58.8 years. It evaluated the efficacy and safety of Revi in treating UUI symptoms in patients with overactive bladder (OAB)-wet.
Key findings included high patient satisfaction, with 95% (83/87) Revi patients reporting therapeutic satisfaction at 36 months. Revi also delivered durable long-term benefits, maintaining therapeutic effectiveness from six to 36 months.
More than three-quarters (79%) of participants registered as therapy responders, having a greater-than or equal-to 50% reduction in UUI episodes from baseline. Additionally, 63% experienced a ≥75% reduction in UUI episodes. Nighttime symptoms improved, too, with nocturia episodes decreasing from 1.3 per day to 0.9 per day. Urgency-related leaks significantly decreased at a sustained level, too, while investigators saw no device- or procedure-related serious adverse events through three years.
“With the most comprehensive and longest-term data in implantable tibial neuromodulation, BlueWind has set a new benchmark for durable, patient-centered therapy for UUI,” said Dmochowski. “Revi delivers consistent, long-lasting outcomes, proving that effective, minimally invasive treatment can be both simple and transformative. These results reinforce Revi’s position as the gold standard for clinical evidence, patient satisfaction, and sustained quality-of-life improvement in urgency urinary incontinence.”
