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Revi® System — Implantable Tibial Nerve Stimulator

The Revi® System (BlueWind Medical, Herzliya, Israel) is a battery-free, externally-powered implantable tibial nerve stimulator — FDA-approved in August 2023 for refractory urgency urinary incontinence. The implant itself is passive; power is delivered by a wearable external controller worn on the ankle like a strap.

Design — Battery-Free Implant + Wearable Power​

Two components:

  1. Implant — small, battery-free device with 2 electrodes and a wireless receiver, placed subfascially near the posterior tibial neurovascular bundle
  2. Wearable — external strap worn on the ankle during stimulation sessions; contains the battery and wireless power transmitter

The implant receives power wirelessly through the skin during patient-controlled stimulation sessions (typically 30–60 min once or twice daily).

Implantation​

  • Outpatient procedure under local anesthesia
  • ~5 cm incision above the medial malleolus
  • Device placed subfascially near the posterior tibial neurovascular bundle
  • No battery replacement needed — implant is permanent

MRI Compatibility​

MR-conditional — an explicit design feature given the patient population (many OAB patients undergo frequent imaging for age-related conditions).

Clinical Efficacy​

Pivotal-trial data reported:

  • ~82% responder rate (≥50% reduction in UUI episodes)
  • ~50% dry rate — notably higher than eCoin's 20–25%
  • >70% achieving "really good" symptom reduction

The higher efficacy reported with Revi may reflect the patient-controlled session timing (vs eCoin's automated schedule) and the more precise subfascial placement adjacent to the neurovascular bundle.

Advantages​

  • Battery-free implant — no replacement, no end-of-device-life concerns
  • Patient-controlled — stimulation timing adjustable
  • MR-conditional from the outset
  • Small implant profile — less surgical footprint than a PGG-with-battery

Limitations​

  • Requires wearable external controller — patient must wear the ankle strap during therapy sessions
  • Battery in the external unit needs periodic charging
  • Compliance depends on patient using the external controller — less automated than eCoin
  • Approval in UUI only at this time

Positioning​

Revi is the externally-powered implantable TNS in a space where eCoin is the self-contained option and Altaviva is the newest self-contained alternative. Selection depends on patient preference for automated vs on-demand therapy and tolerance for a wearable component.

See also: eCoin, Altaviva, PTNS Systems.