FDA clears Revi Extend implant for urgency urinary incontinence

On August 5, 2026, the FDA granted 510(k) clearance to Revi Extend, an updated implantable tibial neuromodulation system (Revi System; BlueWind Medical, Ltd.) for the treatment of urgency urinary incontinence (UUI), featuring an extended device lifespan of 15 years. BlueWind Medical plans a limited US launch in the fourth quarter of 2026.¹

The clearance was supported by 3-year data from the pivotal OASIS trial (NCT03596671) published in The Journal of Urology, which demonstrated durable efficacy, a favorable safety profile, and high patient satisfaction in women with UUI.^1,2

Phase 3 Revi System data for UUI

The OASIS study was a prospective, multicenter, single-arm, open-label pivotal trial evaluating the efficacy and safety of the Revi System in women with UUI who had experienced inadequate responses to prior conservative treatments. Inclusion required at least 9 UUI episodes on a 7-day bladder diary. Of 151 implanted participants, 90 completed the 36-month assessment.²

According to results published in The Journal of Urology, therapy response (50% or greater reduction in UUI episodes from baseline) was achieved in 79% (71/90) of participants at 36 months, while 63% (57/90) achieved a 75% or greater reduction. Additionally, 28% (25/90) of patients were completely dry for 3 consecutive days on a 3-day voiding diary at 36 months. Response rates were consistent across follow-up timepoints, reported at 78%, 82%, 79%, and 79% at 6, 12, 24, and 36 months, respectively.

Participants reported a mean of 1.2 UUI leaks per day at 36 months vs 4.8 per day at baseline. Nocturia episodes decreased from 1.28 per day at baseline to 0.88 per day at 36 months. Total voids per day declined from a mean of 10.0 at baseline to 8.1 at 36 months.

How did patient satisfaction and quality of life hold up at 3 years?

At 36 months, 95% (83/87) of participants who completed satisfaction questionnaires reported being satisfied with the therapy, and 82% (74/90) reported feeling "much better" to "very much better" on the Patient Global Impression of Improvement scale.

A total of 98% (85/87) of participants reported willingness to continue treatment. Clinically meaningful improvements exceeding the minimal important difference threshold were observed across all domains of the Overactive Bladder Questionnaire through 36 months.

What was the safety profile?

No device- or procedure-related serious adverse events were reported through 36 months.^1,2 Device-related adverse events occurred in 11 participants (7.3%) and primarily consisted of pain or stimulation-related discomfort, most of which resolved without intervention or with adjustment of stimulation parameters. A total of 5 participants (3%) underwent surgical explant without complication, and no device migrations or revision procedures were required throughout the study period.²

Study limitations

• Lack of randomization and blinding, a common limitation among neuromodulation studies
• The extended study was initiated after some participants had already completed the 12-month visit, reducing the number of participants available at 3 years
• A last observation carried forward analysis was performed to address potential selection bias from loss to follow-up, which may have inflated positive outcome reporting
• The study included participants with severe baseline UUI, making it unclear whether stimulation frequency requirements would differ for those with milder symptoms

The Revi System is performed as a single minimally invasive procedure under local anesthesia, requiring no formal trial phase before implantation, and uses an external battery-operated wearable ankle controller, eliminating the need for future battery replacement surgery.^1,2

References:

1. BlueWind Medical, Ltd. BlueWind Medical announces FDA 510(k) clearance of Revi Extend next-generation implant. News release. Published August 5, 2026. Accessed August 5, 2026. https://www.businesswire.com/news/home/20260805290667/en/BlueWind-Medical-Receives-FDA-510k-Clearance-for-Revi-Extend-Implant
2. Amundsen CL, Sutherland SE, Heesakkers J, et al. Three-year efficacy and safety of Revi implantable tibial neuromodulation from the pivotal OASIS study. J Urol. Published 2026. doi:10.1097/JU.0000000000005062