BlueWind Medical’s Revi System demonstrates long-term effectiveness for urge urinary incontinence treatment

BlueWind Medical, Ltd., a leader in implantable tibial neuromodulation (iTNM) technology, has announced compelling two-year results from its pivotal OASIS study, reinforcing the efficacy and safety of its Revi System in treating urge urinary incontinence (UUI). Published in the March 2025 issue of the Journal of Urology, the study highlights the Revi System’s results in providing durable symptom relief, high patient satisfaction, and a strong safety profile for individuals living with this often-debilitating condition.

What makes the Revi System an effective treatment for urge urinary incontinence?

The OASIS study evaluated 151 adult women diagnosed with UUI, also known as overactive bladder-wet syndrome (OAB-wet), to assess the long-term performance of the Revi System. Participants had a mean age of 58.8 years, reflecting a demographic commonly affected by UUI. The study’s primary focus was to measure the Revi System’s results in reducing urge urinary incontinence episodes while ensuring patient safety over a two-year period.

Key findings from the study demonstrated that 79% of participants experienced a reduction of at least 50% in UUI episodes, while 56% saw reductions of 75% or more. Notably, 28% of patients achieved complete dryness, as recorded in three-day voiding diaries. These outcomes underscore the Revi System’s ability to deliver sustained symptom relief, with patients continuing to benefit well beyond the initial treatment phase.

The system’s patient-centric design allows individuals to personalise their therapy schedules. In the second year of the OASIS study, patients shifted from daily 30-minute sessions to a more flexible routine of at least two 30-minute sessions per week. Despite this reduced frequency, participants maintained strong therapeutic responses, highlighting the Revi System’s adaptability to varying patient needs without compromising its effectiveness.

How does the Revi System improve patient satisfaction and quality of life?

Patient satisfaction is a critical measure of treatment success in managing chronic conditions like UUI. The OASIS study reported exceptionally high satisfaction rates, with 97% of participants stating they felt “better” or “very much better” after using the Revi System. This high level of satisfaction reflects not only the system’s clinical efficacy but also its ease of use and the autonomy it offers patients in managing their symptoms.

Unlike traditional therapies for urge urinary incontinence, which often rely on medications with potential side effects or more invasive surgical interventions, the Revi System is minimally invasive and does not require general anaesthesia or complex implantation procedures. This approach reduces recovery times and the risk of complications, making it an attractive option for patients seeking effective, low-risk solutions for urge urinary incontinence.

Moreover, the system’s strong safety profile was evident throughout the study. There were no device-related serious adverse events, migrations, or revision procedures reported, reinforcing the Revi System’s reliability as a long-term treatment option.

Why is the CMS reimbursement decision important for the Revi System’s future?

In November 2024, BlueWind Medical received a significant boost when the Centers for Medicare & Medicaid Services (CMS) finalised a favourable reimbursement adjustment for the Revi System. The national unadjusted Ambulatory Surgical Center (ASC) payment rate for Category III CPT code 0817T, which includes the Revi System, was increased by 40% to $19,839 for 2025. The Hospital Outpatient setting reimbursement also saw a 3% increase, reaching $21,444.

This CMS decision reflects growing recognition of the clinical value that implantable tibial neuromodulation offers in treating UUI. By increasing reimbursement rates, CMS acknowledges the Revi System’s durability, safety, and high patient satisfaction, positioning it as an innovative solution within the urge urinary incontinence treatment landscape.

Steve Armstrong, Chief Financial Officer and General Manager of BlueWind Medical, emphasised that this development not only validates the system’s clinical benefits but also enhances accessibility for patients, allowing more individuals to benefit from this advanced therapy without facing financial barriers.

How does the Revi System compare to sacral neuromodulation?

In addition to the OASIS study, BlueWind Medical published a comprehensive meta-analysis in October 2024 in the peer-reviewed journal Advances in Therapy. This analysis compared the efficacy and safety of implantable tibial neuromodulation with sacral neuromodulation (SNM), another neuromodulation therapy commonly used to treat urge urinary incontinence and overactive bladder.

The meta-analysis reviewed data from 20 clinical studies involving over 1,700 patients and found that iTNM offers comparable efficacy to SNM, with notable advantages in patient satisfaction and quality of life. Specifically, 88.5% of iTNM patients reported significant improvements in their symptoms, compared to 74.9% of SNM patients. Additionally, 83.2% of iTNM patients experienced meaningful improvements in health-related quality of life, far exceeding the 48.4% reported among SNM recipients.

One of the Revi System’s key differentiators is its minimally invasive approach. Unlike SNM, which often requires a pre-implantation trial phase and the use of general anaesthesia, the Revi System can be implanted without these additional steps. This makes the treatment process simpler and less burdensome for patients while maintaining comparable therapeutic outcomes.

What role does the Revi System play in the future of UUI management?

The Revi System’s success comes at a time when there is increasing concern about the long-term use of anticholinergic medications for UUI, which have been linked to cognitive decline and dementia. As a result, healthcare providers and professional organisations are advocating for earlier consideration of minimally invasive therapies like iTNM.

Updated 2024 guidelines from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction recommend incorporating neuromodulation therapies earlier in the treatment process, emphasising shared decision-making between patients and healthcare providers. The Revi System’s unique ability to be used without requiring prior failure of conservative therapies aligns perfectly with this shift in treatment philosophy.

Dr Roger Dmochowski, Chief Medical Advisor at BlueWind Medical, noted that the two-year OASIS study results affirm the Revi System’s role as a transformative solution in UUI management. “Our mission is to improve the quality of life for people affected by urge urinary incontinence, and the Revi System represents a significant step forward in achieving that goal,” he said.

As BlueWind Medical continues to innovate in the field of neuromodulation, the Revi System stands out as a versatile, patient-friendly, and effective option for those seeking lasting relief from urge urinary incontinence.