Devices

FDA-authorized wirelessly powered tibial nerve stimulator for urgency incontinence, from the De Novo review and 2024 510(k). Trial result values were not extracted.

Catalog specification sheet - Peripheral nerve

BlueWind Revi tibial neuromodulation

Primary source →

Record ID
BTSD-FDA-0014
Reviewed
2026-10-08
Interface
pni
Evidence stage
human

Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.

BlueWind Revi tibial neuromodulation

The Revi System is a battery-less implant near the tibial nerve at the ankle, powered by a wearable unit, for urgency incontinence. This sheet comes from the FDA De Novo review (DEN220073) and the 2024 510(k) record. Clinical result percentages were not extracted and stay Unreported.

Identity

FieldValue and source scope
DeviceBlueWind Revi System: battery-less Implant, Rechargeable Wearable Unit with leg band, Clinician Programmer and a Hub [1]
ManufacturerBlueWind Medical Ltd., Herzliya, Israel [1][2]
Interface classWirelessly powered implanted tibial nerve stimulator [1]
OriginCommercial FDA-authorized device; De Novo request received October 5, 2022; the pivotal study is named OASIS, and the review text also refers to the system as RENOVA iStim [1]
First demonstratedUnreported
First human implantUnreported
Species studiedUnreported
Regulatory statusDe Novo DEN220073 (implanted tibial electrical urinary continence device, product code QXM); 510(k) K240037 decision May 2, 2024, substantially equivalent [1][2]
FunctionTreatment of urgency incontinence alone or with urinary urgency by tibial nerve stimulation [1]
Target tissueTibial nerve near the ankle, in the vicinity of the tibial neurovascular bundle [1]

Geometry and architecture

FieldValue and source scope
Interface typeImplantable wireless neurostimulator placed subfascially near the tibial neurovascular bundle [1]
Array layoutUnreported
Electrode countUnreported
PitchUnreported
Electrode lengthsUnreported
Shank width and thicknessUnreported
Tip and exposed site geometryUnreported
Contact coatingUnreported
InsulationUnreported
Insertion methodUnreported
Anchoring and fixationUnreported

Electrode and channel physics

FieldValue and source scope
Exposed site areaUnreported
Electrode materialUnreported
Impedance (with measurement frequency)Unreported
Noise floor or SNRUnreported
Recording modalityUnreported
Sampling rateUnreported
Stimulation capabilityFrequency up to 30 Hz; amplitude steps of 0.1 mA, frequency steps of 1 Hz, treatment duration steps of 5 minutes [1]
Charge injection limitUnreported
Reference and groundUnreported

Tissue interface and bioresponse

FieldValue and source scope
Target tissueUnreported
Insertion trauma and BBB disruptionUnreported
Vascular disruption riskUnreported
Micromotion sensitivityUnreported
Gliosis and encapsulationUnreported
Neuron loss near sitesUnreported
Foreign-body response mitigationUnreported
Typical failure modesUnreported

System architecture

FieldValue and source scope
Onboard electronicsImplant has no internal power source; the Wearable Unit holds the circuit board, flexible antenna and battery and pairs to one implant [1]
Data pathBluetooth between the Wearable Unit and a Hub, which transfers data to the cloud during charging sessions [1]
Telemetry bandwidthUnreported
Sampling rateUnreported
PowerWearable Unit: Li-ion rechargeable 1400 mAh, 3.1-4.2 V; up to 1 week of therapy per charge. The implant draws power wirelessly [1]
Thermal managementUnreported
Packaging and hermeticityUnreported
MRI compatibilitySponsor testing showed the Implant is MR compatible at 1.5 T and 3 T under specified conditions [1]
Surgical complexityUnreported
Output connectorsUnreported

Performance envelope

FieldValue and source scope
Acute yieldUnreported
Chronic yieldUnreported
Stability over timeUnreported
LongevityUnreported
Revision and explant experienceUnreported
Adverse eventsUnreported
Notable demonstrationsUnreported

Clinical and preclinical evidence

FieldValue and source scope
Human subjectsOASIS pivotal study: 27 sites; 282 consented and screened, 151 implanted (intent-to-treat set) [1]
Preclinical cohortUnreported
Follow-up durationVisits at activation (4 weeks plus or minus 2 weeks after implant), then 1, 3, 6 and 12 months after activation [1]
IndicationsUrgency incontinence alone or combined with urinary urgency [1]
Trials and registriesOASIS (OverActive Bladder Stimulation System Study); registry ID not extracted here [1]
Primary outcomesPrimary effectiveness endpoint: proportion of responders at 6 months after activation, defined as at least 50% improvement in average urge urinary incontinence episodes on a 7-day diary, against a 50% performance goal. The responder result was not extracted here [1]
Key limitationsResult percentages and adverse event rates from the De Novo review were not extracted; use of the Revi name versus RENOVA iStim in the review text is the same sponsor system per the context but the review’s own naming is mixed [1]

Engineering tradeoffs

FieldValue and source scope
StrengthsBattery-less implant powered by a wearable unit; MR conditional at 1.5 T and 3 T [1]
LimitationsPatient must wear and charge the external unit [1]
Scaling constraintsUnreported

Version boundary

The De Novo review calls the sponsor’s system Revi in its description and RENOVA iStim in some trial text. The 510(k) K240037 (decision May 2, 2024) lists the Revi System. Later changes are not described here.

References

  1. FDA De Novo review, DEN220073.
  2. FDA 510(k) K240037 record, Revi System.