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Male physician holding the Revi device between his fingers while talking to patient out of view.
Male physician holding the Revi device between his fingers while talking to patient out of view.
Revi.

Unlock a path forward for your UUI patients

Male physician holding the Revi device between his fingers while talking to patient out of view.
Male physician holding the Revi device between his fingers while talking to patient out of view.

Introducing a transformative new therapy for urge urinary incontinence (UUI). BlueWind Revi™ is a minimally invasive, implantable tibial neuromodulation device that will transform care for UUI. 

Revi provides patient-centric neuromodulation for people living with UUI:

  • Minimally invasive. Battery-free miniature device implanted in a single, safe procedure under anesthesia.
  • Predictable placement. Subfascial placement allows for direct visualization of the tibial nerve. Intraoperative testing and suture fixation provide for more confident outcomes.
  • Customized therapy. Treatment is optimized based on patient response. Modern technology allows provider visibility into patient adherence and response.

Demonstrated efficacy and favorable safety profile

In the OASIS prospective, multi-center, pivotal study of 151 women with urge urinary incontinence, Revi demonstrated significant reductions in UUI episodes after 6 months of treatment in the ITT population (P<.0001) without device or procedure related serious adverse events (SAE’s) and no surgical revision or reintervention due to battery depletion, lead fracture, or implant migration. In the Completers analysis* (N=139) at 12 months, Revi demonstrated:1,2

Two middle aged women doing yoga in the park.

82%

of patients had ≥ 50% reduction in UUI episodes.

67%

of patients had ≥ 75% reduction in UUI episodes.

50%

of patients were dry for 3 consecutive days.

Transforming UUI therapy with Revi

Revi offers a groundbreaking treatment solution for people with UUI, particularly those dissatisfied with their current therapy or on the sidelines ‘watchful waiting.’ Surgeons should follow current clinical guidelines as applicable and should use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System. With data-driven efficacy and thoughtful design, the Revi System is the key to addressing the unmet needs of both the UUI patients who have been suffering and the healthcare professionals who treat them. 

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BlueWind Medical’s patient-centric focus means we are fully committed to enhancing the quality of life and overall well-being of patients by delivering innovative peripheral neuromodulation solutions, initially focusing on those living with urge urinary incontinence.

*Completers analysis represents the patients with available data at 12 months.

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

References

1. Heesakkers, J. et al. (2023, April 30). Pivotal Study of a Novel Wirelessly Powered, Patient Tailored Programmed, Tibial Neurostimulator for the Treatment of Patients with Overactive Bladder. AUA 2023.

2. Amundsen C. et al. OASIS Pivotal Trial to Evaluate The Safety and Efficacy of the Renova iStim System for the Treatment of Women With OAB. June 2022; 28(6) S223 Female Pelvic Med Reconstr Surg