Axonics
Sacral Neuromodulation System™
Axonics Sacral Neuromodulation (SNM) offers a choice between systems without compromising therapy longevity, using an interchangeable tined lead to support flexibility in clinical decision‑making and helps you future‑proof therapy for your patients.
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Overview
No compromises, just long-lasting therapy
With Axonics Sacral Neuromodulation, the choice between a rechargeable and recharge-free neurostimulator comes without compromising therapy longevity.
Why choose Axonics SNM?
Axonics has improved the patient and healthcare provider experience with sacral neuromodulation therapy, allowing patients to receive long-lasting relief without compromise.
Axonics F15™ SNM System: Longest recharge-free battery life in SNM
The Axonics F15 System has redefined the recharge-free experience by delivering longer battery life and a truly recharge-free system.
About the system
- Battery life of 17.6 years at 1 mA and over 20 years at lower energy settings*
- Patients do not recharge any system components
- Thin design — only 10 cc in size
- Delivers constant current stimulation intended to reduce therapy amplitude adjustments
*Stimulation settings at frequency 14 Hz, pulse width 210 μs, impedance 1200 ohms
Axonics R20™ SNM System: Revolutionising the neurostimulator recharge experience
The Axonics R20 System is designed to last 20+ years and offers the longest recharge interval available in SNM, providing patients the freedom to live more and recharge less.
About the system
- Proprietary titanium-ceramic design, allowing for safe and efficient charging
- Typical recharging interval every 6 to 10 months
- Charges wirelessly through the skin
- Designed to last 20+ years
- Miniaturised device, only 5 cc in volume
- Delivers constant current stimulation intended to reduce therapy amplitude adjustments
Ease of charging
In a clinical study of patients who completed a 2-year follow-up:
- 91% rated the recharging experience as "easy"
- 94% found charging frequency and duration to be "acceptable"1
Intuitive remote control
For both the F15 recharge-free and R20 rechargeable SNM systems:
- Designed to be pocket-sized and easy to use
- One-handed operation to connect to implantable neurostimulator (INS)
- Allows increase or decrease of stimulation
Patented interchangeable tined lead design
- Patented helical-tined lead designed to mitigate lead migration
- Visible and radiopaque markers for lead implantation
- Compatible with both F15 recharge-free and R20 rechargeable systems
MRI conditionally safe
Broad MRI access:
- 1.5 T and 3 T Full-Body Coil1.
- 5 T and 3 T Head Coil1.
- 5 T and 3 T Upper and Lower Extremity
- 1.5 T Full-Body Coil with Open Impedances (F15 only)
- 3 T Full-Body Coil with Lead Fragments (F15 only)
Under certain conditions. For more information refer to Contact Us - Boston Scientific
SmartMRI™ technology:
- Designed to simplify the process for your patients to get an MRI
- Using the Remote Control, the patient or MRI Radiographer can easily confirm if a patient's Axonics System is ready to undergo a full-body MRI
- No additional office visit needed prior to MRI
Smart programming
A smart clinician programmer with a proprietary algorithm designed to simplify the programming process
- Proprietary algorithm that generates programming recommendations based on intra-operative responses and lead placement
- Designed to reduce the need to adjust therapy
- In a clinical study, 92% of patients were on one of their top two recommended programs after one year²
Compatible system components to streamline the therapy experience
- Clinician programmer to test stimulation during lead placement and program therapy settings
- External trial system offers basic and advanced trial options that are lightweight and discreet
- One tined lead compatible with both F15 and R20 systems, further improving the therapy experience and offering flexibility in clinical decision making
The Axonics SNM Trial System
Axonics SNM offers the ability to trial the therapy and assess symptom improvement prior to having your patient undergo the full implant procedure. The trial is not specific to a system and utilises an external trial simulator (ETS).
Two types of trials
Basic Trial
A Basic SNM Trial, or peripheral nerve evaluation (PNE), utilises a temporary lead and ETS.
The temporary lead is placed via a minimally invasive outpatient procedure.
Advanced Trial
An Advanced Trial utilises a tined lead that is connected to the ETS via a percutaneous extension.
This option offers a longer trial period to test the efficacy of the therapy with the permanent tined lead.
Clinical data
2021, Neurourology Urodynamics, Pezzella et al.
Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system
The ARTISAN-SNM study is a 129-patient, single-arm, prospective, multicenter, pivotal clinical study approved under an FDA Investigational Device Exemption (IDE) to evaluate the safety and efficacy of Axonics Therapy for urinary dysfunction. The study was conducted in a total of 19 centers, 14 in the United States, and 5 in Western Europe with 2-year follow-up.
93% experienced improvement at 2 years
93% of implanted patients had greater than or equal to 50% reduction in UUI symptoms.
94% satisfied at 2 years
94% of patients were “satisfied” with Axonics SNM therapy.
Less than 2% of patients reported implant site pain at 2 years
Less than 2% of patients reported implant site pain.
2020, Neurourology Urodynamics, Blok et al.
Two‐year safety and efficacy outcomes for the treatment of overactive bladder using a long‐lived rechargeable sacral neuromodulation system
The RELAX-OAB study was a 51-patient, post-market clinical follow-up study in Europe designed to test the safety and efficacy of Axonics Therapy for the treatment of overactive bladder. The study was conducted across 7 European centers. Patients in the RELAX-OAB study have completed long-term follow-up out to 2 years, showing sustained efficacy and safety of Axonics Sacral Neuromodulation Therapy.
90% continued response
90% of test responders continued to respond to therapy at 2 years.
3x clinically meaningful improvement
In our clinical study, patients on average had a 29-point improvement (P <.0001; n=28) in quality of life, nearly 3 times the threshold for clinically meaningful improvement.
0 serious device-related adverse events
No serious device-related adverse events were reported with the Axonics System.
Publication list
2018, Neurourology Urodynamics, Blok et al.
2018, Neurourology Urodynamics, Blok et al.
Three-month clinical results with a rechargeable Sacral Neuromodulation system for the treatment of overactive bladder
2018, Neurourology Urodynamics, Elterman
The novel Axonics rechargeable Sacral Neuromodulation System: Procedural and technical impressions from an initial North American experience
2018, Neurourology Urodynamics, Blok et al.
A prospective, multicenter study of a novel, miniaturized rechargeable Sacral Neuromodulation system: 12-month results from the RELAX-OAB study
Technical specifications
The system features of the Axonics F15 and the Axonics R20
| Feature | Axonics F15 | Axonics R20 |
|---|---|---|
| Type | Recharge-free | Rechargeable |
| Recharging interval | N/A | Every 6 to 10 months |
| Battery life | 17.6 years at 1 mA and over 20 years at lower energy settings* | 20+ years |
| Neurostimulator case | 10 cc Titanium | 5 cc Titanium-ceramic |
| MRI labeling | 1.5T and 3T full-body MRI scans 1.5T and 3T head coil MRI scans 1.5T and 3T upper and lower extremity MRI scans 1.5T full-body coil with open impedances 3T full-body coil with lead fragments** |
1.5T and 3T full-body MRI scans 1.5T and 3T head coil MRI scans 1.5T and 3T upper and lower extremity MRI scans** |
| Stimulation type | Constant current | Constant current |
*Stimulation settings at Frequency 14 Hz, Pulse Width 210 μs, impedance 1200 ohms
*Under certain conditions. For more information refer to Contact Us - Boston Scientific
Ordering information
| Product Description | UMO | Quantity | UPN |
|---|---|---|---|
| Tined Lead | EA | 1 | 1201 |
| Charging System | EA | 1 | 1401 |
| External Trial Stimulator | EA | 1 | 1601 |
| PNE Lead Implant Kit | EA | 1 | 1701 |
| Tined Lead Implant Kit | EA | 1 | 1801 |
| PNE Lead | EA | 1 | 1901 |
| Patient Remote Control | EA | 1 | 2301 |
| F15 Recharge-Free Neurostimulator | EA | 1 | 4101 |
| R20 Rechargeable Neurostimulator | EA | 1 | 5101 |
| Foramen Needle, Short | BX | 6 | 9001-S |
| Foramen Needle, Long | BX | 6 | 9001-L |
| Stimulation Ground Cable (Ground Pads) | BX | 6 | 9003 |
| Torque Wrench | BX | 10 | 9004 |
| Charging Adhesive Carrier | BX | 9 | 9005 |
| Needle Test Stimulation Cable | BX | 6 | 9006 |
| Tined Lead Stimulation Cable | BX | 6 | 9007 |
| Charging Belt, Regular Length | EA | 1 | 9008-R |
| Charging Belt, Extended Length | EA | 1 | 9008-E |
| Percutaneous Extension | EA | 1 | 9009 |