BlueWind Medical received US Food and Drug Administration 510(k) clearance on 5 August 2026 for Revi Extend, an updated version of its implantable posterior-tibial-nerve neuromodulation device for urgency urinary incontinence. The stated update is device longevity, extended from 10 years to 15 years on the same therapeutic platform.
Revi Extend is the second 510(k) in the Revi family. The base Revi System was authorised on 17 August 2023 via FDA De Novo classification grant, which established the device classification. The Enhanced Revi wearable received the first 510(k) in the family on 16 December 2025. The 5 August 2026 clearance is the second 510(k), referencing the classification established by the 2023 De Novo grant.
Editorial note on scope
Revi is a peripheral-nerve stimulator targeting the posterior tibial nerve at the ankle to modulate the S2-S4 sacral reflex arc controlling bladder function. It is not a brain-computer interface. InsideBCI covers it under the bioelectronic-medicine adjacency scope alongside CVRx Barostim, Orchestra BioMed AVIM, SetPoint Medical, and other implantable peripheral-nerve and cardiac-neuromodulation platforms.
The device
A clinician places the base Revi implant outpatient under local anaesthesia. There is no on-board battery and no lead extensions. An external wearable delivers power wirelessly; the patient self-administers daily home sessions. Revi Extend extends implant longevity from 10 to 15 years.
The OASIS trial that supported the update
The multicenter prospective single-arm OASIS trial (NCT03596671) enrolled 151 women with urgency urinary incontinence. Design is single-arm, not sham-controlled. Amundsen CL, Sutherland SE, Heesakkers JPFA, Toozs-Hobson P, Martens F, McCrery RJ and colleagues published the three-year results in the Journal of Urology (2026;216(2):219-229, doi:10.1097/JU.0000000000005062). Of the 151 enrolled, 140 (93%) completed 12-month follow-up and 90 completed 36-month follow-up.
The published outcomes: at three years, 79% of participants achieved a 50% or greater reduction in urgency urinary incontinence episodes on 3-day voiding diaries, and 63% achieved a 75% or greater reduction. Responder rate held stable from 78% at 6 months to 79% at 36 months. Patient-reported therapeutic satisfaction was 95%. On the Patient Global Impression of Improvement (PGI-I), 82% of participants rated themselves as “much better” or “very much better.” The trial reported no device-related or procedure-related serious adverse events through 3 years.
Three-year OASIS data was presented at the SUFU 2026 Winter Meeting.
The single-arm caveat
OASIS is a single-arm study with no sham control. A single-arm design can support durability and safety findings across three years, and it can support the responder-rate stability observed from 6 to 36 months. A single-arm trial cannot resolve the placebo contribution, a real methodological consideration for neuromodulation devices in urgency urinary incontinence. Regulators and payers reading the OASIS data will weight the 3-year durability against the absence of a sham-controlled comparator.
Commercial trajectory
BlueWind Medical closed a $47.8 million equity and debt financing in May 2026 to fund US commercial sales team expansion and market access work. The lead investor was not named in the release. CEO is Kerry Nelson, CFO is Stephen Armstrong, and CMO is Roger Dmochowski MD. BlueWind has indicated a Q4 2026 limited US launch for Revi Extend.
Where Revi Extend sits in the sacral neuromodulation market
The established sacral neuromodulation category is anchored by Medtronic’s InterStim family and Axonics’ r-SNM System, both of which deliver stimulation to the sacral nerve via an implanted electrode powered by an on-board battery. BlueWind’s own positioning is narrow: the first FDA-cleared implantable tibial neuromodulator powered by a battery-operated external wearable, cleared for urgency urinary incontinence. The claim is a scoped carveout on the wearable-powered tibial variant, not a broad “first tibial neuromodulation” claim. The incumbent sacral neuromodulation devices target a different nerve.
What to watch
Commercial ramp through Q4 2026 and into 2027. BlueWind has raised the growth capital and stated the launch window. The measurable question is implant volumes.
US payer coverage decisions. Whether Revi Extend lands as a covered alternative to sacral neuromodulation will set the ceiling on adoption. US SNM uptake has historically tracked payer coverage more tightly than clearance timing, and Revi Extend faces the same dynamic.
A sham-controlled follow-up study, whether from BlueWind or an academic partner. A positive sham-controlled readout would close the methodological gap that a single-arm design leaves open and would strengthen the device’s position against payer and guideline scrutiny.