Revi — Implantable Tibial Neuromodulation
Revi (BlueWind Medical) uses a battery-free implant near the tibial nerve, powered during treatment by an external rechargeable wearable. FDA granted De Novo classification on August 16, 2023 for urgency incontinence alone or with urinary urgency. The indication does not explicitly require prior conservative-treatment failure; however, the pivotal study largely enrolled previously treated patients.[1]
Components and Current Models
The system includes the implant, rechargeable wearable, clinician programmer and data-transfer hub. The implant is placed subfascially near the posterior tibial neurovascular bundle and secured to fascia. Patients wear the external unit during prescribed home sessions after healing. The absence of an implanted battery avoids internal battery-depletion replacement, but does not eliminate charging, device failure, explantation or other repeat procedures.[1][2]
| Update | What changed |
|---|---|
| December 12, 2025 — K252391 | Updated wearable with a replaceable rechargeable battery, revised controls and associated software |
| July 28, 2026 — K253651 | Modified implant materials/manufacturing and 15-year labeled implant life, versus 10 years for its predicate |
The manufacturer calls the newer implant Revi Extend and announced a limited US launch planned for Q4 2026. The 15-year specification is supported by device testing, including active aging; it is not 15 years of observed clinical success and should not be applied automatically to older implants. External equipment has its own service and replacement requirements.[3][4]
OASIS Evidence — Keep the Denominators Visible
OASIS was prospective, multicenter, open-label and single arm: 282 people screened, 151 women implanted. Most had failed conservative therapy; stable OAB medication was permitted. A response meant at least 50% reduction in UUI episodes.[1][5]
| Analysis | Result | Important boundary |
|---|---|---|
| FDA intention-to-treat analysis | 76.4% at six months; 78.4% at 12 months | Missing-data handling included; 12-month efficacy analysis was posthoc |
| Two-year report | 79% of 97 completers responded | Selected follow-up cohort |
| Three-year report | 71/90 (79%) responded; 25/90 dry on a three-day diary | 90 provided diaries from 151 originally implanted; 119 entered the extension |
At three years, 83/87 questionnaire respondents were satisfied. These data support persistent benefit among many participants remaining in follow-up, but loss to follow-up, lack of blinding and absence of a comparator limit interpretation. Different diary lengths and changing populations also complicate cross-time comparisons.[1][6][7]
The three-year report observed no device- or procedure-related serious adverse events, but recorded wound and stimulation-related problems and explantations. “No serious events observed” is not a guarantee of zero risk, and cannot establish superiority to an SNM cohort followed for a different period.[7]
Safety and Practical Selection
Assess ability to use the wearable independently or with assistance, lower-leg skin and circulation, prior local surgery/trauma, other implants and pregnancy. Current manufacturer contraindications include obstructive BPH or other lower-tract obstruction, unsuitable local tissue/vascular conditions and specified nearby metal implants. Safety and effectiveness are not established in all neurological populations. Consult the complete current model-specific instructions.[2]
Revi is MR Conditional, not unrestricted. The implant's 1.5T/3T conditions include scanner, anatomical landmark, energy and scan-time limits; external components are MR Unsafe. Diathermy and other energy procedures need separate review. Battery-free design does not make the implant immune to heating or interference.[2]
Position Relative to PTNS and SNM
The 2024 AUA/SUFU guideline permits individualized minimally invasive treatment without mandatory preceding trials, but its unabridged Statement 25 specifically names percutaneous tibial stimulation. The guideline's implantable-device section gives no specific recommendation because direct comparative evidence was lacking. It should not be cited as Grade A support for Revi itself.[8]
A 2025 meta-analysis pooled separate SNM and implantable-tibial cohorts; it was not a head-to-head comparison. Similar pooled response estimates do not establish equivalent benefit, fewer revisions or lower lifetime cost. For Revi, discuss the home wearable and charging commitment alongside surgery, current model labeling and the predominantly female evidence base.[9]
See also: PTNS systems, eCoin, Altaviva, InterStim and Axonics.
References
1. FDA. De Novo classification review: Revi System. DEN220073, August 16, 2023. Review.
2. BlueWind Medical. Revi Important Safety Information. Current manufacturer summary. Contraindications, service life and MRI precautions.
3. FDA. Revi System 510(k) summaries. K252391, December 12, 2025, updated wearable; K253651, July 28, 2026, implant lifetime extension. Wearable; implant.
4. BlueWind Medical. BlueWind Medical Receives FDA 510(k) Clearance for Revi Extend Implant. August 2026 manufacturer announcement. Planned limited Q4 launch.
5. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A Prospective Study to Assess the Effectiveness and Safety of the BlueWind System in the Treatment of Patients Diagnosed With Urgency Urinary Incontinence. Neurourology and Urodynamics. 2024;43(7):1491-1503. doi:10.1002/nau.25477
6. 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. The Journal of Urology. 2025;213(3):323-332. doi:10.1097/JU.0000000000004328
7. Amundsen CL, Sutherland SE, Heesakkers JPFA, et al. Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation From the Pivotal OASIS Study. The Journal of Urology. 2026. doi:10.1097/JU.0000000000005062
8. AUA/SUFU. Idiopathic Overactive Bladder Guideline, 2024. Statements 23–25 and implantable-tibial-stimulation discussion, pp 30–32. Unabridged guideline.
9. Amundsen CL, Sutherland SE, Kielb SJ, Dmochowski RR. Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-Analysis. Advances in Therapy. 2025;42(1):10-35. doi:10.1007/s12325-024-03019-0