Axonics Sacral Neuromodulation Systems
Axonics, part of Boston Scientific, offers both rechargeable and recharge-free sacral neuromodulation. This page covers its hardware and device-specific evidence; the InterStim/SNM hub discusses broader trial comparisons, neurogenic selection and long-term reintervention.
Current Models
| System | Power and model | Manufacturer specification |
|---|---|---|
| F15 | Recharge-free, model 4101; 10 cc | Projected 17.6-year battery life at 1 mA, 14 Hz, 210 µs and 1200 Ω; life varies with energy requirements |
| R20 | Rechargeable, model 5101; 5 cc | Designed for 20+ years; current typical recharge interval six to ten months |
R20 is not recharge-free. Older R15/ARTISAN charging schedules should not be copied onto R20, and neither projected battery life nor a small generator guarantees freedom from revision. Both current systems use constant-current stimulation; select the actual generator, lead and accessories together.[1]
Labeling, MRI and Patient Tasks
US labeling covers OAB symptoms and urinary retention after inadequate response or intolerance to conservative therapy, plus chronic fecal incontinence after failure of or unsuitability for conservative therapy. It excludes mechanical urinary obstruction. An appropriate test-stimulation response is required, and inability to operate the system is a contraindication.[2]
The fully implanted systems are MR Conditional. Eligibility and scanner limits depend on model, lead configuration and current MRI instructions; external trial equipment has different restrictions. Do not describe full-body 1.5 T/3 T eligibility as unrestricted MRI access. Diathermy is prohibited, and electrosurgery, ablation and other energy procedures need specific precautions.[1][2][3]
The patient needs access to the remote and follow-up support; rechargeable models also require a sustainable charging plan. Neurological-origin urinary dysfunction, pregnancy and pediatric use have important labeling limitations. Device selection should account for dexterity, cognition, caregiver support, anticipated MRI and the patient's preferences.[2]
ARTISAN-SNM — Clinical Benefit and Denominators
ARTISAN was a single-arm prospective study of 129 people with UUI, 98% women, using an earlier rechargeable Axonics system. It used single-stage research implantation rather than a required new external test phase; nine participants had already passed an earlier external trial without receiving a full implant. That study design does not override current labeling or establish routine single-stage implantation as the best approach.[4][5]
| Follow-up | Reported response: at least 50% UUI reduction |
|---|---|
| Six months | Approximately 90% in the all-implanted analysis |
| One year | 89% across 129 participants |
| Two years | 93% of 121 completers, versus 88% of all 129 when missing/exited participants counted as failures |
At two years, 82% achieving at least 75% reduction and 37% being dry were percentages of the 113 responders, not all implanted participants. Recharging was acceptable to 94% of the 121 follow-up participants. The study reported 14 surgical interventions in 11/129 participants, despite no unanticipated or serious device/procedure-related adverse events.[4][6][5]
The results support meaningful benefit for many patients, while the uncontrolled design, predominance of women and manufacturer sponsorship limit comparisons and generalization. They are not twenty-year R20 outcomes.
RELAX-OAB likewise requires denominator care: 51 were implanted, but its 94% one-year response was reported among initial test responders, rather than all 51. Early and selected-responder studies should not be pooled informally into a universal success percentage.[7]
Rechargeable Versus Recharge-Free
One retrospective single-center comparison found revisions in 34% of 150 rechargeable recipients versus 13.5% of 96 nonrechargeable recipients. Charging difficulty accounted for 35.3% of rechargeable revisions. It raises a practical counseling issue but does not prove an inherent class-wide disadvantage across models or that the newest R20 has the same burden.[8]
Favorable charging satisfaction in ARTISAN does not guarantee acceptability in an individual patient. Device choice should connect expected treatment benefit with the patient's ability to manage the specific system.
The 2025 SNM-versus-implantable-tibial meta-analysis used separate single-arm cohorts, not a randomized head-to-head comparison. Similar pooled rates cannot establish equivalence or cheaper lifetime care.[9]
Tined-Lead Insertion Safety Update
October 2025 notices from Health Canada and the Australian TGA described difficulty advancing some model 1201 tined leads through the introducer sheath, associated with adhesive affecting tine deflection. The notices recommend backup kits and exchange of affected devices; implanted-lead performance was not affected. The Australian correction was closed in January 2026. Check current local manufacturer instructions if resistance is encountered rather than forcing advancement or assuming an implanted lead needs removal.[10]
For test placement and operative technique, see Sacral Neuromodulation. For other device options, see PTNS systems, eCoin, Revi and Altaviva.
References
1. Boston Scientific. Axonics Sacral Neuromodulation System. Current US F15/R20 specifications and model numbers. Product resource.
2. Axonics/Boston Scientific. Important Safety Information — United States/Canada. Current manufacturer summary. Indications, contraindications and precautions.
3. Axonics/Boston Scientific. Current manuals library. Select the actual model, country and current MRI physician guidelines. Manufacturer manuals.
4. McCrery R, Lane F, Benson K, et al. Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study. The Journal of Urology. 2020;203(1):185-192. doi:10.1097/JU.0000000000000458
5. Pezzella A, McCrery R, Lane F, et al. Two-Year Outcomes of the ARTISAN-SNM Study for the Treatment of Urinary Urgency Incontinence Using the Axonics Rechargeable Sacral Neuromodulation System. Neurourology and Urodynamics. 2021;40(2):714-721. doi:10.1002/nau.24615
6. Benson K, McCrery R, Taylor C, et al. One-Year Outcomes of the ARTISAN-SNM Study With the Axonics System for the Treatment of Urinary Urgency Incontinence. Neurourology and Urodynamics. 2020;39(5):1482-1488. doi:10.1002/nau.24376
7. Blok B, Van Kerrebroeck P, de Wachter S, et al. A Prospective, Multicenter Study of a Novel, Miniaturized Rechargeable Sacral Neuromodulation System: 12-Month Results From the RELAX-OAB Study. Neurourology and Urodynamics. 2019;38(2):689-695. doi:10.1002/nau.23892
8. Cohen T, Huang Z, Aalami-Harandi A, et al. Revision Rates for Rechargeable Versus Non-Rechargeable Sacral Neuromodulation Devices in the Management of Overactive Bladder. Neurourology and Urodynamics. 2025;44(5):1031-1035. doi:10.1002/nau.70053
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. Health Canada. Axonics SNM System — Tined Lead, model 1201. October 22, 2025, RA-78345; Australian TGA product correction RC-2025-RN-00854-1. Health Canada; TGA action and handling instructions.