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Revi® System — Implantable Tibial Neuromodulation (iTNM)

The Revi system (BlueWind Medical, Herzliya, Israel) is a novel implantable tibial neuromodulation (iTNM) device and the first FDA-cleared implantable neuromodulation device that does not require prior failure of more conservative treatments — i.e., it can be offered to non-refractory UUI patients.[1][2]

History​

BlueWind Medical was founded in Israel to overcome the two major limitations of percutaneous tibial nerve stimulation: weekly office visits and indefinite maintenance.[3][4][5]

  • 2013–2015 — first-generation device, the RENOVA iStim — a battery-free implant powered wirelessly by an external unit.[4][6]
  • 2017 — first-in-human (n = 15): median operative time 34 min; significant ↓ frequency, severe urgency, severe incontinence at 3 mo.[4]
  • 2020 — RENOVA 3-yr follow-up: 75% treatment success at 36 mo; no technical failures.[6]
  • 2018–2024 — OASIS pivotal trial (151 women, multicenter US/Europe).[1][2]
  • ~2023 — FDA clearance for UUI, without requirement of prior conservative-treatment failure.[1][2]
  • 2025–2026 — 2-yr and 3-yr OASIS outcomes confirm durable efficacy and exceptional safety.[1][2]

Device Design — Three Components​

1. Miniature Battery-Free Implant (~3 cm)[4][7]​

  • Subfascial placement near the posterior tibial nerve, just above the medial malleolus.
  • Electrode contacts + mounting hardware for fascial suturing.
  • No internal battery → no battery depletion, no replacement surgery, theoretically unlimited device lifespan.
  • A critical design advantage over SNM (battery replacement every 5–15 yr) and eCoin (finite primary battery).

2. External Wearable Ankle Band[1][7]​

  • Battery-operated, patient-controlled; worn over the implant during sessions.
  • Powers the implant wirelessly via radiofrequency magnetic coupling.
  • Bluetooth data transfer.
  • Patients self-administer therapy at home with adjustable duration / intensity.

3. Clinician Programmer[7]​

Tablet-based interface for stimulation parameters, treatment data review, and programming.

Mechanism​

Stimulation of the posterior tibial nerve (L4–S3) — shares sacral roots with bladder, pelvic floor, and urethral sphincter innervation. Afferent modulation of sacral spinal cord activity inhibits detrusor overactivity, the same mechanism as percutaneous PTNS supported by level-I sham-RCT evidence.[3][8]

Implantation Technique​

Minimally invasive, local anesthesia ± sedation:[4][9]

  1. ~5 cm incision above the medial malleolus.
  2. Posterior tibial nerve identified.
  3. Implant placed subfascially adjacent to the nerve.
  4. Intraoperative testing confirms motor / sensory response (toe flexion or paresthesia in the sole).
  5. Implant sutured to fascia to prevent migration.
  6. Closure.

Operative time: median 34 min.[4]

Advantages: no abdominal/buttock incision (unlike SNM); no trial-stimulation phase — single procedure; no fluoroscopy; outpatient.

Clinical Trials​

RENOVA (First-Generation Device)​

  • First-in-human 2017 (n = 15): frequency 11.8 → 8.1 voids/d (p = 0.002); severe urgency 6.5 → 2.0/d (p = 0.002); severe incontinence 2.8 → 0.3/d (p = 0.017); 1 explantation for suspected infection (cultures negative).[4]
  • 3-yr follow-up (Dorsthorst 2020): 20/34 patients continued; 75% treatment success at 36 mo (PP and ITT); 73% reported clinically meaningful QoL improvement; no technical failures.[6]

OASIS Pivotal Trial — n = 151​

Prospective, multicenter, single-arm:[1][2][9]

TimepointResponder rate (≥ 50% UUI reduction)Other
6 mo78%93% (140/151) completed 12-mo follow-up
12 mo82%—
2 yr (n = 97 completers)79%97% satisfaction; 80% "much better" / "very much better" on PGI-I; no device- or procedure-related SAEs
3 yr (n = 90 completers, 76% of extension)79%95% therapeutic satisfaction; 82% PGI-I "much better" / "very much better"; no device- or procedure-related SAEs

Responder rate remarkably stable from 6 mo through 3 yr (78 / 82 / 79 / 79%).

Quality of Life (Sutherland 2026)​

Dedicated OASIS QoL analysis:[9]

  • Clinically significant (≥ 10-point) and sustainable improvements in all OAB-q and HRQL domains through 24 mo.
  • 96.8% treatment benefit; 96.7% satisfaction; 100% willing to continue therapy.
  • Among participants who did not meet the primary efficacy endpoint (n = 20, 20.6%): 83.3% still reported benefit, 66.7% satisfied, 100% willing to continue — a striking signal that subjective benefit extends beyond the binary responder definition.

Safety​

Exceptionally favorable across all studies:[1][2][4][9]

  • No device- or procedure-related SAEs through 3 years.
  • No technical / mechanical failures in the RENOVA 3-yr follow-up.[6]
  • First-in-human: 3 prolonged antibiotics, 3 short-course pain medication, 1 explantation for suspected infection (cultures negative).[4]
  • Battery-free design eliminates depletion, replacement-surgery, and charging-related complications.
  • Sutured fascia fixation — no reported migration.

This profile contrasts sharply with SNM, which has 43% cumulative reoperation rates at 8 yr in Medicare data, and rechargeable SNM with ~36% revision rates partly driven by charging / connectivity issues.[10]

Unique Regulatory Distinction — Non-Refractory Patients​

The Revi is the first implantable neuromodulation device cleared for use without prior failure of conservative treatment.[1][2]

  • Patients do not need to have failed behavioral therapy, pharmacotherapy, or PTNS before receiving Revi.
  • Aligns with AUA/SUFU OAB 2024 Clinical Principle that clinicians may offer minimally invasive procedures to patients unable or unwilling to undergo behavioral / non-invasive / pharmacologic therapies, and Expert Opinion that minimally invasive therapies may be offered without prior trials.[11]
  • Positions Revi as a potential early intervention rather than a last-resort therapy.

Revi vs Other iTNM Devices​

FeatureRevi (BlueWind)eCoin (Valencia / Boston Scientific)Medtronic iTNM (TITAN 2)
PowerBattery-free (wirelessly powered)Primary non-rechargeable batteryRechargeable, leadless
Implant size~3 cmNickel-sized (~2 cm)Miniaturized leadless
LocationSubfascial near nerveSuprafascial over nerveNear tibial nerve
ControlPatient-controlled (wearable)Automatic pre-programmedPatient-controlled
Battery lifeUnlimited (none)Finite ~3 yrRechargeable
Trial phaseNoneNoneNone
Cleared for non-refractory patientsYes (first device)NoPending
Pivotal 6-mo responder78%68%59%
1-yr responder82%65–68%61%
2-yr responder79%78%—
3-yr responder79%——
Serious device-related AENone at 3 yr1 SAE (wound)1 SAE (resolved)
Satisfaction95–97%~70%—

References: [1][2][12][13][14][4][9][15][16]

The Revi shows numerically higher responder rates than both the eCoin and the Medtronic iTNM in their respective pivotal trials, though no head-to-head trials exist.

Revi vs SNM​

Amundsen 2025 SR / meta-analysis (iTNM vs SNM):[10]

  • UUI responder: SNM 71.8% vs iTNM 71.3% — similar.
  • OAB responder: SNM 73.9% vs iTNM 79.4% — similar.
  • Similar device-related AE rates.
  • iTNM achieves comparable efficacy without a trial stimulation phase — simpler pathway, lower cost.

Advantages of Revi vs SNM:

  • No trial phase; single-stage implantation.
  • No buttock / abdominal surgery — lower leg under local anesthesia.
  • No battery replacement.
  • No charging required (unlike rechargeable Axonics / InterStim Micro).
  • No MRI restrictions from pelvic / spinal hardware.
  • No device- or procedure-related SAEs through 3 yr.
  • Cleared for non-refractory patients.

Potential disadvantages vs SNM:

  • Less long-term data (3 yr vs > 20 yr for SNM).
  • No data for non-obstructive retention or fecal incontinence.
  • Requires wearing external ankle band during sessions.
  • No head-to-head RCT vs SNM.

Guideline Position​

AUA/SUFU OAB 2024:[11]

  • Moderate Recommendation (Grade A) — offer SNM, tibial nerve stimulation, and/or intradetrusor OnaBT for inadequate response to pharmacotherapy or behavioral therapy.
  • Expert Opinion — may offer minimally invasive therapies (including iTNM) without prior trials.
  • Clinical Principle — may offer minimally invasive procedures to patients unable or unwilling to undergo behavioral / non-invasive / pharmacologic therapies.

Bottom Line​

The Revi represents a significant innovation in OAB / UUI neuromodulation: a battery-free implant eliminating depletion / charging / replacement, minimally invasive lower-leg implantation under local anesthesia, durable efficacy (78–82% responder rates stable from 6 mo to 3 yr), exceptional satisfaction (95–97%), and zero serious device-related AEs through 3 years.[1][2][9] Its unique FDA clearance for non-refractory patients positions it as a potential early intervention. Longer-term data and head-to-head comparisons with SNM and OnaBT are still needed.[2][10]

See also: eCoin, Altaviva, PTNS Systems, Medtronic InterStim, Axonics SNM.

References​

1. 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

2. 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

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

4. 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

5. Vollstedt A, Gilleran J. Update on Implantable PTNS Devices. Current Urology Reports. 2020;21(7):28. doi:10.1007/s11934-020-00980-5

6. 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

7. 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

8. Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. The Journal of Urology. 2010;183(4):1438-1443. doi:10.1016/j.juro.2009.12.036

9. 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. doi:10.1007/s00192-026-06538-2

10. 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

11. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder. The Journal of Urology. 2024;212(1):11-20. doi:10.1097/JU.0000000000003985

12. Lee U, Xavier K, Carey J, et al. Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence From the TITAN 2 Pivotal Study. The Journal of Urology. 2026;215(6):702-712. doi:10.1097/JU.0000000000004958

13. MacDiarmid S, Staskin DR, Lucente V, et al. Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. The Journal of Urology. 2019;201(5):967-972. doi:10.1016/j.juro.2018.10.017

14. Lucente V, Giusto L, MacDiarmid S. Two-Year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin® for Urgency Urinary Incontinence. Urology. 2024;194:17-23. doi:10.1016/j.urology.2024.07.046

15. Gilling P, Meffan P, Kaaki B, et al. Twelve-Month Durability of a Fully-Implanted, Nickel-Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Urology. 2021;157:71-78. doi:10.1016/j.urology.2021.04.039

16. Rogers A, Bragg S, Ferrante K, Thenuwara C, Peterson DKL. Pivotal Study of Leadless Tibial Nerve Stimulation With eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial. The Journal of Urology. 2021;206(2):399-408. doi:10.1097/JU.0000000000001733