BlueWind Medical Announces Two-Year Durability Data for Revi® System
BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) therapies, announced today the publication of the two-year results from its pivotal OASIS study in the Journal of Urology (March 2025 issue). The study evaluated the Revi® System, a patient-centric treatment solution designed to alleviate urgency urinary incontinence (UUI) in adult women with overactive bladder-wet syndrome (OAB-wet). The OASIS study is a prospective, multicenter, single-arm, open-label clinical trial involving 151 women with a mean age of 58.8 years. It assessed the safety and efficacy of the Revi system for treating UUI, focusing on primary efficacy endpoints at six and 12 months, with 97 participants completing the 24-month assessment.
The study’s findings revealed that the Revi System delivered durable efficacy, a favorable safety profile, and high levels of patient satisfaction, making it a promising treatment for UUI. Specifically, a sustained response to therapy was observed in year two, as patients were able to follow a more flexible treatment schedule. In contrast to the first year, where patients participated in daily 30-minute sessions, patients in the second year averaged at least one session on eight out of ten days, tailored to their individual symptom needs.
Key results from the OASIS study’s two-year analysis include:
- Durable Reduction in UUI Episodes:
- 79% of participants experienced a ≥50% reduction in UUI episodes.
- 56% of participants achieved a ≥75% reduction in UUI episodes.
- These reductions in UUI episodes were sustained over the two-year period, indicating long-term efficacy.
- High Patient Satisfaction:
- 97% of participants reported being satisfied with their treatment.
- 97% of participants felt “better” to “very much better” following their therapy with the Revi system.
- Freedom from Leaks:
- 28% of patients reported being dry, as demonstrated by a three-day voiding diary, which is a significant improvement in managing UUI.
- Substantial Reduction in Large Volume Leaks:
- One of the most debilitating aspects of UUI is large volume urgency-related leaks. The study showed a notable decrease in such leaks, from 0.9 leaks per day to just 0.1 per day, providing significant relief to patients.
- Safety Profile:
- The Revi system demonstrated an excellent safety profile, with no device- or procedure-related serious adverse events.
- There were no device migrations or revisions, ensuring the long-term viability of the therapy.
Dr. John Heesakkers, Chairman of the Department of Urology at the Maastricht University Medical Center in the Netherlands, commented on the significance of the Revi system’s flexibility: “What sets Revi apart is its patient-centricity. The system allows patients to tailor treatment intervals to their symptoms and providers to individualize treatment plans to each patient. It is encouraging to see that the OASIS study long-term data continues to validate the Revi System as a durable and effective treatment for UUI.”
The need for non-pharmacologic treatment options for UUI has become more critical, especially given recent concerns about the potential link between anticholinergic agents and dementia. The Revi system stands out as the first implantable tibial neurostimulation device approved for UUI treatment, without the requirement for patients to fail or tolerate more conservative therapies. This unique labeling opens the door for earlier intervention, empowering patients and healthcare providers to explore non-invasive, effective options before resorting to medications or surgical procedures.
The OASIS study results align with the updated 2024 guidelines from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, which recommend considering minimally invasive therapies early in UUI treatment. The guidelines emphasize shared decision-making between healthcare providers and patients, and Revi fits this model perfectly.
Roger Dmochowski, M.D., Chief Medical Advisor at BlueWind Medical, remarked on the significance of the two-year results: “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. Our commitment remains steadfast to enhancing treatment options and elevating the quality of life for people grappling with UUI.”
BlueWind Medical’s Revi® System is a groundbreaking treatment for UUI, delivering both a long-lasting and personalized approach to managing a condition that affects millions of women worldwide. The system uses implantable tibial neurostimulation combined with a wearable, battery-operated device to activate the treatment. The Revi system provides a patient-driven, flexible treatment schedule, allowing patients to adjust treatment intervals according to their symptoms, offering a significant advantage over traditional therapies.
With a clear focus on patient-centric solutions, BlueWind Medical continues to lead the charge in transforming the landscape of neuromodulation therapy for UUI. By providing a safe, effective, and minimally invasive solution, BlueWind is enhancing the lives of those living with this challenging condition.
About BlueWind Medical Ltd.
BlueWind Medical is at the forefront of neuromodulation therapy, developing innovative and patient-centric medical technologies. The company’s focus is on improving the lives of people living with urge urinary incontinence (UUI), and its Revi® System is the first FDA-cleared implantable tibial neuromodulation device for UUI treatment. BlueWind Medical is committed to enhancing the quality of life of its patients through advanced, effective, and minimally invasive therapeutic options.
