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

Clinically proven to be the key to treating UUI

Of patients who completed the study* (124/130) were satisfied with the treatment at 12 months

High patient satisfaction

Following treatment with BlueWind Revi^® 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 12 months. In addition, 85% of patients implanted with Revi experienced a ≥ 10 point improvement, a clinically meaningful benefit, in their Health-Related Quality of Life (HRQL) score at 12 months.

Proven efficacy, proven results

In the OASIS pivotal study, Revi demonstrated significant reductions in urge urinary incontinence (UUI) episodes after 6 months of treatment in the ITT population (P<.0001). In the Completers analysis* (N=139) at 12 months, Revi demonstrated:¹

82%

of patients had ≥ 50% reduction in UUI episodes.

67%

of patients had ≥ 75% reduction in UUI episodes.

50%

of patients were dry on 3 consecutive days.

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 12 months:^1,2

No device or procedure-related serious adverse events (SAEs)
No surgical revision/reintervention related to 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 reduction in UUI episodes over time, particularly in those seeing a ≥ 75% improvement. By 12 months, an impressive 66.9% of patients who completed this study saw a ≥ 75% improvement in their UUI due to patient-centric programming.¹

Bar chart displaying how the patient-centric programming improves over time.

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.
9+ UUI episodes during a 7-day diary were required for inclusion.
≥ 50% reduction in UUI episodes compared to baseline was the primary endpoint.

Highly regarded OASIS oversight

OASIS’ Data Safety Monitoring Board and Clinical Events Committee are comprised of some of the most highly regarded physicians in academia, ensuring the highest level of scientific rigor and ethical oversight. Their objective and independent perspective is invaluable in helping to ensure that the study results are valid, reliable, and relevant.

Data & Safety Monitoring Board (DSMB)

Howard B. Goldman, MD

Cleveland Clinic Cleveland, OH

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Howard B. Goldman, MD

Cleveland Clinic Cleveland, OH

Howard B. Goldman is a Professor on the faculty of the Cleveland Clinic Lerner College of Medicine and an expert in quality and patient safety serving as the Institute Vice Chairman for Quality at the Glickman Urologic Institute. He has a joint appointment in the departments of urology and obstetrics and gynecology and is actively involved in the training of fellows and residents, including serving as Fellowship director for Female Pelvic Medicine and Reconstructive Surgery in the Department of Urology at the Cleveland Clinic. He has directly trained over 35 fellows and residents who are specialized FPMRS practitioners. Dr. Goldman’s interests are in the medical and surgical treatment of urinary incontinence and other types of voiding dysfunction, neuromodulation, prolapse repair, complex reconstructive female urologic surgery, and neuro-urology. His contributions to the literature have been prolific, including the author of over 250 articles and book chapters, editor of three textbooks, and panel member for a number of standardization, guidelines, and best practice statement panels. Within the AUA he has been on the SUI Guidelines as well as Urodynamics guidelines committees. Within ICS he has been on the male LUTS terminology committee as well as the ICS/IUGA female prolapse terminology committee. He also led the group that came up with the ICS sacral neuromodulation best practices document. His prominent international reputation has led to invitations as visiting professor in the United States and abroad as well as numerous invited lectures. He is on the editorial board of a number of journals and is a former Assistant Editor of the Journal of Urology. He is currently the co-director of the AUA annual review course for part 1 of the ABU exam, is on the AUA Education committee, serves as online education director for IUGA, is the scientific co-chair for the 2020 ICS annual meeting, was the program co-chair for the 2020 SUFU meeting, was on the program committee for the 2020 International Neurourology Society and is the International Consultation on Incontinence committee chair for surgery for male incontinence. Dr. Goldman has been involved in and led numerous projects related to innovative treatments utilizing stem cells for SUI, neuromodulation, utilization of urodynamics, management of complications, and improvements in safety and efficiency in pelvic floor surgery. Dr. Goldman is an astute physician-scientist, nurturing educator, model leader, and unwavering patient advocate renowned in the field of urology.

Holly E. Richter, MD

University of Alabama Birmingham, AL

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Eric S. Rovner, MD

Medical University of South Carolina Charleston, SC

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Clinical Event Committee (CEC)

Gary Lemack, MD

University of Texas Southwestern Dallas, TX

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Gary Lemack, MD

University of Texas Southwestern Dallas, TX

Gary Lemack, M.D., is a Professor in the Department of Urology at UT Southwestern Medical Center, and he is the holder of the Rose Mary Haggar Professorship. He also has a secondary appointment in the Department of Neurology. Dr. Lemack is board certified in Urology and Female Pelvic Medicine and Reconstructive Surgery. Since 2004, he has been the Residency Program Director in the Department of Urology, and he is the past Program Director for the Female Pelvic Medicine and Reconstructive Surgery Fellowship. His clinical specialties include urinary incontinence, pelvic organ prolapse, overactive bladder, and voiding dysfunction in the setting of neurologic disease. In particular, Dr. Lemack cares for patients with bladder conditions stemming from spinal cord injury, multiple sclerosis, and movement disorders such as Parkinson’s Disease. He performs complex urinary diversions for patients with severe bladder disorders due to congenital and advanced neurological diseases. Dr. Lemack earned his medical degree from Cornell University and performed his residency at The New York Hospital. His fellowship training at UT Southwestern focused on incontinence, urodynamics, and neuro-urology. He has been a faculty member at UT Southwestern since 1999 and is also active in research. Dr. Lemack's clinical research has focused on the use of urodynamic studies in patients with lower urinary tract dysfunction/incontinence and on establishing best urological practices in the care of patients with multiple sclerosis, spinal cord injury, and other neurological conditions. Texas Monthly has honored Dr. Lemack with its Super Doctor award, and D Magazine has named him the Best Doctor in Dallas on multiple occasions, including in 2020. Dr. Lemack is the Past President of the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), which is the primary urology subspecialty organization devoted to the conditions affecting the pelvic floor, such as incontinence and prolapse. He has been on the Executive Committee of SUFU since 2005 and has earned both the Paul Zimskind and Distinguished Service awards from SUFU, two of the highest honors that the Society bestows. Dr. Lemack has been on the Board of the South Central Section of the American Urological Association and is a former member of the Editorial Board of the Journal of Urology. He is one of 12 Trustees of the American Board of Urology and currently serves as the Chair of the Oral Examination Committee for the Board. Dr. Lemack has authored two guidelines from the American Urological Association (Urodynamics and Stress Urinary Incontinence) and served as the lone American representative on The European Association of Urology Incontinence Guidelines. He has authored over 160 original articles and over 25 book chapters. Dr. Lemack has also been a Visiting Professor at 25 locations throughout the United States, South and Central America, and Australia.

Sandip Vasavada, MD

Cleveland Clinic Cleveland, OH

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Sandip Vasavada, MD

Cleveland Clinic Cleveland, OH

Sandip Vasavada, MD, is the Urologic Director of the Center for Female Urology and Reconstructive Pelvic Surgery at Cleveland Clinic, located within the Glickman Urological Institute. He, along with his colleagues, represents one of the largest centers for female urology and reconstructive genitourinary surgery in the country. Additionally, he serves as a Professor of Surgery (Urology) at the Cleveland Clinic Lerner College of Medicine and has a joint appointment with the Women's Health Institute. Dr. Vasavada completed his medical school training in the competitive six-year combined BS/MD program at Northeastern Ohio Universities College of Medicine in 1991. After graduating, he began his urology residency at Cleveland Clinic and graduated from the residency program in 1997. Subsequently, he started a fellowship in female urology, neuro-urology, and reconstruction at the UCLA School of Medicine in Los Angeles, California. He then took a position as Assistant Professor of Urology at Thomas Jefferson Medical College in Philadelphia before returning to Cleveland in 2001. Dr. Vasavada has published numerous manuscripts and book chapters in the area of voiding dysfunction and urinary incontinence. He has been named to "Top Docs" in Philadelphia and Cleveland magazines for over 15 years, Crains Cleveland Business Top 40 under 40, and the Urology Department Teacher of the Year. Dr. Vasavada has published three textbooks and authored over 100 manuscripts, over 25 book chapters, and numerous abstracts and videos. He has lectured and demonstrated surgical techniques around the world in over 20 countries. He is also a reviewer for seven major journals in the field of urology, urogynecology, and voiding dysfunction. Dr. Vasavada recently completed a term on task force A of the American Board of Urology Exam Committee and helped author the American Urological Association (AUA) and Society of Urodynamics and Female Urogenital Reconstruction (SUFU) Guidelines in Overactive Bladder and Stress Urinary Incontinence for the country. Additionally, he presently serves as Vice President of SUFU. Dr. Vasavada's primary clinical interests lie in the area of urinary incontinence, pelvic organ prolapse, complex reconstruction of the lower urinary tract, and management of complications of vaginal and lower urinary tract surgery. His current research interests are in the field of refractory bladder overactivity and neuromodulation and care pathways for optimizing care in patients undergoing incontinence and prolapse surgery. Dr. Vasavada serves with the Section of Urogynecology on the NIH-Pelvic Floor Disorders Network.

Eli Sidon, MD

Schneider Children’s Hospital Petah-Tikva, Israel

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Pilot study demonstrated durable efficacy at 3 years

At 36 months in a prospective, interventional, multi-center, single-arm study, the results were durable with a 75% success rate in the intention-to-treat (ITT) analysis (n=20). In addition, 80% of the ITT analysis had a greater than 50% reduction in the number of large volume leaks at 36 months, the most debilitating type of leaks.³

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.

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

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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

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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

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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 urinary incontinence treatment

Check out our publications

*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. 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.

3. Dorsthorst MJ, Digesu GA, Tailor V, Gore M, van Kerrebroeck PE, van Breda HMK, Elneil S, Heesakkers J. 3-year follow-up of a new implantable tibial nerve stimulator for the treatment of Overactive Bladder Syndrome. Jurol Vol. 204, 545-550, September 202. https://doi.org/10.1097/JU.0000000000001024

Revi for Urge Urinary Incontinence

About BlueWind

Clinically proven to be the key to treating UUI

High patient satisfaction

Proven efficacy, proven results

82%

67%

50%

Favorable safety profile

Patient-centric programming improves outcomes over time

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).

Highly regarded OASIS oversight

Data & Safety Monitoring Board (DSMB)

Howard B. Goldman, MD

Holly E. Richter, MD

Eric S. Rovner, MD

Clinical Event Committee (CEC)

Gary Lemack, MD

Sandip Vasavada, MD

Eli Sidon, MD

Pilot study demonstrated durable efficacy at 3 years

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

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

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)

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

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

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