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Female physician walking to elderly women in her office and showing her documents.
Female physician walking to elderly women in her office and showing her documents.

Clinically proven to be the key to treating UUI

Female physician walking to elderly women in her office and showing her documents.
Female physician walking to elderly women in her office and showing her documents.

Of patients who completed the study* (83/87) were satisfied with the treatment at 36 months

High patient satisfaction

Following treatment with BlueWind Revi® in the OverActive Bladder Stimulation System Study (OASIS)—a prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder (OAB)—patients reported high levels of satisfaction and saw some or much benefit in their treatment at 36 months. In addition, 82% of patients with a Revi implant said they felt “much better” at 36 months compared to before starting therapy.

Proven efficacy, durable results

In the same study, Revi began seeing significant reductions in urge urinary incontinence (UUI) episodes as early as one month. At 36 months (N=90)*, Revi maintained efficacy and durable outcomes:1

79%

of patients had ≥ 50% reduction in UUI episodes.

63%

of patients had ≥ 75% reduction in UUI episodes.

28%

of patients were dry on a 3 day diary.

0%.

Favorable safety profile

Revi’s leadless implant design with activation by a rechargeable external wearable, combined with its reproducible surgical technique, has resulted in an exceptional safety profile that underscores its transformative benefits as a urinary incontinence device. Of the patients implanted with Revi at 36 months:1,2

  • No device or procedure-related serious adverse events (SAEs)
  • No surgical revision/reintervention related to battery change, lead fracture, or lead migration
  • No unanticipated adverse events

Patient-centric programming improves outcomes over time

With the ability to individually tailor and optimize treatment parameters, Revi demonstrates a durable improvement in UUI episodes over time, particularly in those seeing a ≥75% improvement. By 36 months, an impressive 63% of patients saw a ≥75% improvement in their UUI due to patient-centric programming.1,2

The OASIS pivotal trial is a prospective, single-arm, open-label study conducted to evaluate the safety and efficacy of the Revi System for treating patients with urge urinary incontinence (UUI).

The OASIS trial consisted of:

  • 23 leading medical centers across the U.S., U.K., and Europe.
  • 151 women enrolled.
  • Participants experienced an average of 4.8 UUI episodes per day, with an average of 0.9 large leaks per day, prior to treatment.
  • Primary endpoint was ≥50% reduction in UUI episodes compared to baseline was the primary endpoint.
RESTORE Clinical Study
At BlueWind Medical we are committed to expanding access of tibial neuromodulation to physicians and their patients. To further this mission, we are conducting the RESTORE clinical study to better understand how Revi can improve patients’ lives.

The RESTORE Clinical Study consists of:

  • Prospective, interventional, multi-center, post market randomized controlled study with participants across the U.S.
  • Goal: Compare results between patients receiving Revi treatments vs. no treatment
  • Demonstrate: Reduction in UUI episodes and large-volume accidents with improvements in Health-Related Quality of Life (HRQL)

With data-driven efficacy and thoughtful design, BlueWind Revi could deliver on the unmet needs of UUI patients who have been suffering and the healthcare professionals who treat them.

Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder:  A Systematic Review and Meta-analysis (2025)

Purpose/objective: Implantable tibial neuromodulation (iTNM) systems have recently become commercially available in the US, and offer a new method of neurostimulation for the treatment of overactive bladder (OAB). In the absence of head-to-head studies, the aim of this meta-analysis was to indirectly compare the efficacy and safety of sacral neuromodulation (SNM) and implantable tibial neuromodulation (iTNM) for the treatment of OAB.
Advances In Therapy
View Publication

Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence.

Purpose/objective: A novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS (Overactive Bladder Stimulation System) study are presented.
The Journal of Urology
View Publication

A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence (2024)

Purpose/objective: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available.
Neurology and Urodynamics
View Publication

A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints (2018)

Purpose/objective: Evaluation of the BlueWind implantable tibial nerve system performance and safety in refractory OAB.
Neurology and Urodynamics
View Publication

A new implanted posterior tibial nerve stimulator for the treatment of overactive bladder syndrome: 3-month results of a novel therapy at a single center (2017)

Purpose/objective: To investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms.
The Journal of Urology
View Publication

3-year follow-up of a new implantable tibial nerve stimulator for the treatment of overactive bladder syndrome (2020)

Purpose/objective: To evaluate the 3-year safety and efficacy of the BlueWind Medical system for the treatment of overactive bladder syndrome.
The Journal of Urology
View Publication

Patient-tailored healthcare and tibial nerve neuromodulation in the treatment of patients with overactive bladder symptoms (2022)

Purpose/objective: To demonstrate features predictive of treatment response for patient-tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors.
Neurology and Urodynamics
View Publication

Learn more about how Revi’s research advances urge urinary incontinence treatment

*Completers analysis represents the patients with available data at 36 months.

For further information on the OASIS study and other on-going clinical studies, please visit clinicaltrials.gov (OASIS NCT03596671)

References

1. Amundsen C. et al. Three-year efficacy and safety of Revi Implantable Tibial Neuromodulation from the pivotal OASIS Study. April 2026 JUro https://doi.org/10.1097/JU.0000000000005062

2. Sutherland, S et. al. OASIS Pivotal Trail to Evaluate the Safety and Efficacy of the Renova iStim System and for the Treatment of Women with OAB. Jurol. 2022; 207(S5):e1043.