PARK CITY, Utah--(BUSINESS WIRE)--BlueWind Medical, Ltd., a leader in implantable Tibial Neuromodulation (iTNM) and developer of the Revi® System, a patient-centric solution for urge urinary incontinence (UUI), announced today the publication of a comprehensive meta-analysis in the October issue of the peer-reviewed publication Advances in Therapy. “Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-analysis” highlights the efficacy and safety of iTNM for treating UUI and overactive bladder (OAB), supporting it as a compelling alternative to sacral neuromodulation (SNM). The findings are particularly relevant to the Revi System, which is based on iTNM technology.
The meta-analysis, encompassing data from 20 clinical studies with a total of 1,766 patients, underscores that iTNM offers comparable efficacy and safety to SNM. Key findings include:
- Promising Trends of Higher Patient Satisfaction: In studies reporting patient satisfaction 88.5% of iTNM patients reported a “better” or greater Patient Global Impression of Improvement (PGI-I) score compared to 74.9% of SNM patients, indicating higher overall patient satisfaction with iTNM. Additionally, therapy satisfaction rates were notably high, with 95.0% of iTNM patients satisfied compared to 75.5% of SNM patients.
- Improved Quality of Life: Specifically, in studies reporting quality of life outcomes, 83.2% of iTNM patients experienced a clinically significant ≥10-point increase in health-related quality of life (HRQoL) scores, compared to 48.4% of SNM patients.
- Minimally Invasive and Patient-Friendly: iTNM achieves notable therapeutic benefits without requiring a pre-implantation trial phase, fluoroscopy, or general anesthesia, unlike SNM.
- Similar Efficacy Profiles: iTNM and SNM demonstrated comparable rates of symptom response and reduction in UUI episodes. The weighted average decrease in UUI episodes per day was similar for iTNM (3.0 episodes) and SNM (3.5 episodes).
- Low Rates of Adverse Events and Revision: iTNM demonstrates a strong safety profile with potentially lower rates of surgical re-intervention and explant compared to historical data on SNM. The research findings suggest iTNM offers comparable safety to SNM for managing UUI and OAB.
“Recent data suggest that when patients can interact with their device and adjust treatment times and settings, it may lead to a more personalized and durable therapy,” said Cindy Amundsen, M.D., lead author of the meta-analysis, Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery at Duke University. “As new guidelines support earlier use of implantable neuromodulation, this personalized approach may help avoid the long-term use of drug therapy that often leads to patient dissatisfaction by offering an alternate effective and satisfying treatment experience.”
The meta-analysis findings align with recent guidelines from the American Urological Association (AUA), in partnership with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), which advocate for earlier consideration of minimally invasive procedural therapies for managing OAB and UUI. This is particularly significant given concerns over the long-term use of anticholinergic agents and their potential link to cognitive impairment and dementia.
“The publication of this meta-analysis is a milestone that reinforces the Revi System's role as an innovative and effective solution for urge urinary incontinence,” said Roger Dmochowski, M.D., Chief Medical Officer of BlueWind Medical. “We are committed to advancing treatment options and improving the quality of life for patients suffering from UUI and OAB.”
BlueWind Medical is dedicated to transforming neuromodulation therapy through continuous innovation and patient-centric approaches. The Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable, offering a unique therapeutic alternative that meets the evolving needs of patients and healthcare providers.
For additional information about BlueWind Medical and the Revi System, please visit bluewindmedical.com.
About BlueWind Medical Ltd.
BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall wellbeing of patients with an initial focus on those living with urge urinary incontinence (UUI). BlueWind’s Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA marketing authorization for patients with UUI. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating “step-therapy.”
