FDA grants 510(k) clearance to Revi System against urgency urinary incontinence

The FDA has provided 510(k) clearance to the Revi System for long-term management of urgency urinary incontinence (UUI), according to BlueWind Medical, Ltd.¹

The Revi System is a wearable device intended for increased efficacy in providing therapy to patients with UUI. Recent updates to the system include a streamlined, easy-to-use design. The interface is smart and user-friendly, with a simple, 3-button control for easy patient use. These features increase patient confidence and control, making UUI management more convenient.

“Our strong clinical evidence and our focus on patient comfort and satisfaction show that when patients can personalize their therapy, outcomes improve,” said Kerry Nelson, interim CEO of BlueWind Medical. “The enhanced wearable continues that philosophy by making therapy easy to use, adaptable to each patient’s lifestyle, and supportive of long-term use.”

Clinical data demonstrate high efficacy and patient satisfaction

Data has indicated significant efficacy of the Revi System, with 79% of patients reporting a reduction in UUI of at least 50%. Additionally, satisfaction has been reported by 97% of patients using the Revi System, and the device has a strong safety profile with no related serious adverse events, device migrations, or device revision procedures.

The Revi System can be inserted through a single, minimally invasive procedure. This is accomplished under local anesthesia without a trial phase. Additionally, the Revi System has adjustable, wearable control, adapting to each patient’s unique and changing UUI symptoms.

OASIS trial provides 2-year efficacy and safety data

This advancement follows BlueWind’s objective of improving the quality of life of patients with UUI. The group has had advanced implantable tibial neuromodulation since 2010, evolving it into an established therapeutic option supported by a significant amount of clinical evidence.

Two-year follow-up data from the OASIS trial support the recent FDA clearance.² During the trial, 151 women received the Revi System, with efficacy and safety end points evaluated in these patients at 6 and 12 months. Following this period, 97 participants consented to participate in a long-term follow-up evaluating treatment durability and safety.

Therapy response, defined by a reduction in UUI episodes of 50% or greater, was reported in 79% of these patients through a 3-day voiding diary. Additionally, comparable effectiveness was reported at 6, 12, and 24 months, with response rates of 78%, 82%, and 79%, respectively.

Safety outcomes and patient-reported improvement remain favorable

Among patients completing the follow-up assessment, similar demographics and treatment results were reported at the 6-month visit. According to investigators, this indicates that the 24-month results represent the overall study population.

Alongside a 97% satisfaction rate, 80% of patients reported feeling “better” or “much better.” There were also no serious adverse events related to the device or procedure reported during the follow-up period.

“Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile,” concluded investigators.

References

1. BlueWind Medical receives FDA 510(k) clearance for enhanced Revi wearable supporting long-term treatment of urgency urinary incontinence. News release. Business Wire. December 16, 2025. Accessed December 16, 2025. https://www.businesswire.com/news/home/20251216057440/en/BlueWind-Medical-Receives-FDA-510k-Clearance-for-Enhanced-Revi-Wearable-Supporting-Long-Term-Treatment-of-Urgency-Urinary-Incontinence
2. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. Two-year efficacy and safety outcomes of the pivotal OASIS study using the Revi System for treatment of urgency urinary incontinence. J Urol. 2025;213(3):323-332. doi:10.1097/JU.0000000000004328