eCoin — Implantable Tibial Nerve Stimulator
eCoin (Valencia Technologies, now part of Boston Scientific) is a leadless tibial neurostimulator powered by a non-rechargeable battery. US labeling covers urgency urinary incontinence after intolerance of or inadequate response to conservative treatments, or after a successful PTNS trial.[1]
Design and Patient Tasks
The coin-shaped device is implanted subcutaneously above the lower-leg fascia and supplies programmed intermittent stimulation, not continuous therapy. Treatment begins after postoperative healing; the feasibility protocol activated the implant at about four weeks. Clinicians can adjust stimulation amplitude.[2][1]
Although the patient does not wear an external power unit for each session, the system is not free of patient-operated equipment. The patient controller magnet stops unwanted stimulation, and the patient must be able to use it as instructed. Battery life depends on settings; depletion requires device replacement. Discuss wound follow-up, programming and eventual replacement rather than describing the implant as maintenance-free.[1]
Clinical Evidence
The main studies were open-label and single arm.
| Study | Population and result | Interpretation |
|---|---|---|
| Pivotal trial | 137 enrolled, 133 implanted, 132 in the intention-to-treat cohort; 68% achieved at least 50% UUI reduction at 48 weeks (95% CI 60–76%) | Approximately 98% women; no sham or active comparator |
| Two-year extension | 72 completers; 78% responders and 22% dry at 96 weeks | Attrition changes the denominator; this does not prove efficacy increased over time |
The pivotal report found device-related adverse events in 16% through 52 weeks. The extension reported no serious or unanticipated events during that extension period; this does not erase earlier wound or device risks.[3][4]
MRI and Other Safety Requirements
The manufacturer labels eCoin MR Conditional with important positioning restrictions: the implant must remain outside the scanner bore, at least 20 cm from its edge, under the specified 1.5T/3T conditions. The lower leg containing the implant must not enter the scanner. The patient magnet is MR Unsafe. Arrange model-specific MRI review rather than assuming an ankle implant permits every scan.[1]
Other key issues include poor local skin/vascular health or unhealed wounds, inability to operate the controller magnet, diathermy and possible interaction with other implanted electronics. The manufacturer provides specific electrosurgical precautions. Cardiac-device interactions require coordination; the pivotal study excluded pacemakers/ICDs. Lower-leg activity restrictions apply during healing.[1]
Position Among Options
A patient may prefer automatic intermittent stimulation over repeated office visits or a wearable used for each treatment. Balance that convenience against finite battery life, surgery, MRI restrictions and the limited comparative evidence. Claims of less retention than medication or better safety than SNM require direct evidence and are not established by these single-arm trials.
For other choices, see PTNS systems, Revi, Altaviva and InterStim.
References
1. Valencia Technologies, part of Boston Scientific. eCoin Important Safety Information. Current manufacturer labeling summary. Indication, contraindications, MRI and controller instructions.
2. 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
3. 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
4. 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