BlueWind Medical’s Revi implantable tibial neuromodulation (ITNM) system has demonstrated sustained efficacy and safety at the three-year mark in a pivotal trial in urgency urinary incontinence (UUI).
During the single-arm, open-label OASIS study (NCT03596671), 151 adult women with UUI were recruited to evaluate the efficacy and safety of the Revi system in treating overactive bladder, wet. The mean age of patients was 58.8 years.
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At 36 months, 79% of patients fitted with the tibial neuromodulation device were still considered treatment responders – a figure that remained consistent with the 78% response rate observed at the six-month mark. Patients were considered responders if they experienced a ≥50% reduction in UUI episodes from baseline.
Of the 90 efficacy-evaluable patients enrolled on the trial, 63% experienced a ≥75% decrease in UUI episodes, with instances of nighttime urination decreasing from 1.3 to 0.9 times per day. These factors led to a statistically significant drop in UUI episodes and large leaks at 36 months. Of the 87 patients who filled in a treatment outcome questionnaire, 95% reported they were satisfied with Revi’s therapeutic efficacy.
The Revi system was also considered safe and tolerable, as there were no serious treatment-emergent adverse events (TEAEs) associated with either the fitting procedure or the device itself.
As an ITNM, Revi acts by sending targeted stimulation via the posterior tibial nerve to the nerve bundle responsible for bladder function control in the lower spine. This reduces the prevalence of abnormal bladder spasms characteristic of UUI – helping to reduce episodes of urge incontinence. Patients can activate the therapy once daily from home via an external control panel.
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By GlobalDataMedtech bets on neuromodulation
As the European Association of Urology estimates that 20% of the adult population is impacted by urinary incontinence, medtech companies are increasingly investing in their neuromodulation portfolios to combat this chronic issue.
This includes Irish medtech giant Medtronic, which obtained US approval for its Altaviva device in September 2025. At the 2026 J.P. Morgan Healthcare conference in San Francisco, Medtronic CEO Geoff Martha touted the technology’s billion-dollar market potential. “Roughly a 1% penetration of this five million patient pool [the proportion of patients looking to receive treatment for UUI] represents a $1bn revenue opportunity for the company,” Martha said.
Boston Scientific is also looking to gain a slice of this market through its January 2026 acquisition of urology and pelvic health specialist, Valencia Technologies. This saw the company add Valencia’s lead-marketed ITNM product, eCoin, to its urology portfolio, which Boston views as a “high-growth adjacency” to its urology business.
Meanwhile, Neuspera Medical is taking a different approach to treat UUI – instead opting to target the sacral nerve through its integrated sacral neuromodulation system (iSNM). The product secured US Food and Drug Administration (FDA) approval in June 2025.
According to GlobalData’s Medical Device Intelligence Center, Medtronic is currently the leading player within the implantable neuromodulation devices market, which is forecast to be worth $13bn in 2035.
