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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]

History​

The first-generation device, marketed as RENOVA iStim, was a battery-free implant powered by an external unit. In the first-in-human series of 15 patients (13 women, 2 men; 5 previously treated with PTNS), median operative time was 34 minutes.[10] At 3 months, daily frequency fell from 11.8 to 8.1 voids, severe urgency episodes from 6.5 to 2.0 per day and severe incontinence episodes from 2.8 to 0.3 per day. Three patients received prolonged antibiotics, and one device was explanted for pain and swelling suspicious for infection with negative tissue cultures.[10] Three-year follow-up included 20 of the 34 patients originally implanted; overall treatment success was 75% at 36 months in both per-protocol (16) and intention-to-treat (20) analyses, and no technical failures were reported.[11] The current Revi System was evaluated in the OASIS pivotal study, following the earlier RENOVA iStim pilot.[5]

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 battery-operated unit during prescribed home sessions after healing, and it powers the implant during each session. The lower-leg approach avoids an abdominal or buttock incision.[1][2] The absence of an implanted battery avoids internal battery-depletion replacement.[1][2]

Specifications from the 2025 US patient therapy guide and the 2023 US surgical technique guide (manufacturer documents):[14][15]

ItemSpecification
Implant capsule3 cm long, 0.27 cm diameter; with silicone suture wings 3 × 1.3 × 0.35 cm; 0.9 g; two electrodes, 1.7 mm and 4.0 mm long
Implant materialsZirconia ceramic, titanium and gold capsule with Parylene coating; platinum-iridium electrodes; silicone wings
StimulationBiphasic charge-neutral waveform with configurable polarity; up to 30 Hz, up to 14 mA (may vary with software version) and up to 790 μs
Wearable14 × 9.6 × 3.4 cm in the patient guide (3.2 cm in the surgical technique guide) and 165 g (220 g with leg band); sealed 1,400 mAh rechargeable lithium-ion battery, up to 1 week of treatment per charge (charging after each treatment is recommended); logs 365 therapy days
Session30 minutes to 2 hours at the clinician's discretion (typically 30 to 60 minutes); up to four therapy programs, changed only with the manufacturer's representative
Service lifeWearable 1 year; implant 10 years in this guide (the July 2026 clearance below extends it to 15 years for the newer implant)

The patient positions the wearable over the scar, raises it slowly until the beeping and LED blinking are fastest, then tightens the strap. Sessions start at the level from the previous session and the patient adjusts within a preset range. The wearable cannot run while charging. The guide describes strenuous activities such as gymnastics, mountain biking, skiing and sky diving as risks to the implant, and lists running, jogging, road biking and swimming as less extreme. It also warns against scuba diving or a hyperbaric chamber.[14]

Because percutaneous and implantable tibial stimulation target the same nerve, a 2024 narrative review argued that randomized data for percutaneous stimulation inform implantable devices.[12]

UpdateWhat 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 (the 2025 patient guide still states 10 years) 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 consented to screening, 151 women implanted. Participants had inadequate response to conservative and pharmacologic therapy; stable OAB medication was permitted. A response meant at least 50% reduction in UUI episodes.[1][5]

AnalysisResultImportant boundary
FDA intention-to-treat analysis76.4% at six months; 78.4% at 12 monthsMissing-data handling included; 12-month efficacy analysis was posthoc [1]
Two-year report79% of 97 completers respondedSelected follow-up cohort [6]
Three-year report71/90 (79%) responded; 25/90 dry on a three-day diary90 provided diaries from 151 originally implanted; 119 entered the extension [7]

At three years, 83/87 questionnaire respondents were satisfied.[7] 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. In the 12-month report, 82% of the 139 participants with completed diaries were responders and 69/139 (50%) were dry on at least three consecutive diary days; separately, 130/139 (93.5%) participants with available PGI-I data rated their symptoms better, much better or very much better.[1][5][6][7]

The three-year report observed no device- or procedure-related serious adverse events, but recorded wound and stimulation-related problems and explantations.[7]

The manufacturer's surgical technique guide summarizes the clinical events committee classification of the pivotal study (ITT set, implantation to 12 months). Device-related adverse events occurred at a rate of 4%, all pain associated with stimulation. Procedure-related events occurred at 10.6%, of which 6.6% related to the surgical wound, including 2 infections (1.3%) and 1 dehiscence (0.7%). In the same summary, participants taking concomitant OAB medication had a higher 6-month responder rate than those not taking it (89% versus 70%, p = 0.012); 98 participants were not taking OAB medication.[15]

A completers quality-of-life analysis through 24 months reported clinically significant (10 points or more) improvements in all OAB-q domains and the HRQL score. At 24 months, 96.8% reported treatment benefit, 96.7% were satisfied and 100% were willing to continue. Among the 20 participants (20.6%) who did not meet the responder threshold, 18 completed the benefit and satisfaction questionnaire; 15/18 (83.3%) reported benefit and 12/18 (66.7%) were satisfied. This is a completers analysis in a manufacturer-sponsored study.[13]

Safety and Practical Selection​

Assess ability to use the wearable independently or with assistance, lower-leg skin and circulation, prior local surgery or trauma, other implants and pregnancy. The manufacturer's guide lists these contraindications: inability to operate the wearable without help, men with BPH or other lower urinary tract obstruction, a metallic implant within 20 cm of the implant site, nerve damage that could affect therapy, high surgical risk or conditions that cause excess bleeding or poor wound healing, allergy to implant materials, pregnancy, open wounds on the lower leg or foot, prior surgery or unhealed trauma in the implant area, pitting edema of 2+ or more, venous or arterial insufficiency, vasculitis or dermatologic disease of the lower leg, and infection near the site.[15] Safety and effectiveness are not established in patients under 18 or in progressive systemic neurological disease such as Parkinson disease or multiple sclerosis. Shortwave, microwave or ultrasound diathermy is prohibited at any location on the body. Electrosurgery, electrocautery, radiation therapy, high-output ultrasound, lithotripsy, TENS, bone-growth stimulation, RF ablation, lasers, therapeutic magnets and a hyperbaric chamber may injure the patient or permanently damage the implant, particularly when used close to it; the wearable is removed before any such therapy. External defibrillation or cardioversion can damage the implant, so function is confirmed afterward, and the stimulation pulses may interact with cardiac devices that sense cardiac activity. Keep the wearable away from other implanted devices such as pacemakers. Consult the complete current model-specific instructions.[2][14][15]

Revi is MR Conditional with restrictions. The implant's 1.5T/3T conditions include scanner, anatomical landmark, energy and scan-time limits, which the patient guide defers to the surgical technique guide. The patient guide states that the system must not be activated during the scan, that the wearable and accessories are MR Unsafe and never enter the MRI room, that the patient shows an identification card to MRI staff, and that the implant was not tested with other devices in the MRI environment.[14] Diathermy and other energy procedures need separate review.[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.[8]

A 2025 meta-analysis pooled separate SNM and implantable-tibial cohorts; it was not a head-to-head comparison. Weighted UUI responder rates were 71.8% for SNM and 71.3% for implantable tibial neuromodulation.[9]

Compared with SNM, Revi offers a lower-leg implant, and the implantable tibial studies pooled in the meta-analysis did not use a trial phase.[9] Its US indication is not limited to patients who have failed conservative therapy. Its limitations are follow-up of 3 years versus more than 20 years of SNM experience, a UUI-only indication with no data for non-obstructive retention or fecal incontinence, the need to wear and charge an external lower-leg unit, and the absence of a head-to-head trial. The evidence base is predominantly female.[2][7][9]

Implantable tibial systemPower and usePivotal design
Revi (BlueWind)Battery-free implant powered by an external wearable used at home; patient-controlledSingle arm, 151 women; ITT responder rate 76.4% at 6 months[1]
eCoin (Valencia, Boston Scientific)Non-rechargeable implanted battery; automatic programmed stimulationSingle arm, 132 in the ITT cohort; 68% responders at 48 weeks [17]
Medtronic implantable tibial systemLeadless, rechargeableTITAN 2 single arm, 126 implanted; 59% of patients with baseline and follow-up UUI data were responders at 6 months [16]

Response definitions, analysis populations and time points differ between these pivotal studies, and no head-to-head comparison exists.

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;216(2):219-229. 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

10. van Breda HMK, Martens FMJ, Tromp J, Heesakkers JPFA. A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center. The Journal of Urology. 2017;198(1):205-210. doi:10.1016/j.juro.2017.01.078

11. Dorsthorst MJT, Digesu GA, Tailor V, et al. 3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome. The Journal of Urology. 2020;204(3):545-550. doi:10.1097/JU.0000000000001024

12. Lee UJ, MacDiarmid S, Matthews CA, Gillespie E, Peters KM. Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices. Advances in Therapy. 2024;41(7):2635-2654. doi:10.1007/s12325-024-02864-3

13. Sutherland SE, Heesakkers JPFA, Ferrante KL, Dmochowski RR. Impact of Revi Implantable Tibial Neuromodulation on Quality of Life in Patients With Urgency Urinary Incontinence. International Urogynecology Journal. 2026;37(8):2451-2461. doi:10.1007/s00192-026-06538-2

14. BlueWind Medical. Revi Patient Therapy Guide, US edition, G02-CLU-0133 Rev 10 (2025). Manufacturer document for patients.

15. BlueWind Medical. Revi Surgical Technique Guide, US edition, G02-CLU-0131 Rev 03 (2023). Manufacturer instructions for implantation: indications, contraindications, warnings and precautions, summary of clinical evaluation, implantation and explantation procedures, and system specifications (Table 11). Filed with the FCC as an exhibit for FCC ID 2BAXD-E02-0.

16. Medtronic. Patient Guide for the Altaviva System. M028917C001 Rev C, September 16, 2025, pp. 31–33. FDA-hosted label.

17. Rogers A, et al. "Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial." J Urol. 2021;206(2):399-408. doi:10.1097/JU.0000000000001733