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Axonics Sacral Neuromodulation System™

Axonics Sacral Neuromodulation (SNM) is a clinically proven solution for patients with overactive bladder, urinary urge incontinence, urinary retention, and fecal incontinence. Axonics SNM offers the choice between rechargeable and recharge-free systems that deliver a long-lasting therapy experience.

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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 provider experience with sacral neuromodulation therapy, allowing patients to receive long-lasting relief.

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 to reduce therapy amplitude adjustments

*Stimulation settings at frequency 14 Hz, pulse width 210 μs, impedance 1200 ohms

Axonics SNM F15 Product

Axonics R20™ SNM System: Revolutionizing 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
  • Miniaturized device, only 5 cc in volume
  • Delivers constant current stimulation to reduce therapy amplitude adjustments
Axonics SNM R20 Product

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 tined lead design

  • Patented helical-tined design 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 Coil
  • 1.5 T and 3 T Head Coil
  • 1.5 T and 3 T Upper and Lower Extremity
  • 1.5 T Full-Body Coil with Open Impedances
  • 3 T Full-Body Coil with Lead Fragments

Under certain conditions. For more information visit, www.axonics.com/mri.

SmartMRI™ technology:

  • Designed to simplify the process for your patients to get an MRI
  • Using the Remote Control, the MR technician 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

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 utilizes an external trial simulator (ETS).

Axonics SNM trial system

Two types of trials

Basic Trial

A Basic SNM Trial, or peripheral nerve evaluation (PNE), utilizes a temporary lead and ETS.

The temporary lead is placed via a minimally invasive outpatient procedure.

Advanced Trial

An Advanced Trial utilizes 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.

93% experienced improvement

93% of implanted patients who completed two-year follow up had greater than or equal to 50% reduction in UUI symptoms.

94% satisfied

94% of patients who completed two-year follow up were “satisfied” with Axonics SNM therapy.

Less than 2% of patients reported implant site pain

In the two-year clinical study, 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.

Approximately 3x standard for clinical improvement

In our clinical study, patients on average had a 29-point improvement (P <.0001; n=28) in quality of life, more than 3 times the bar for clinically meaningful improvement.

0 serious device-related adverse events

Treatment with the Axonics System was well tolerated with no serious device-related adverse events reported.

Publication list

The system features of the Axonics F15 and the Axonics R20

Axonics F15

Type
Recharge-free
Recharging interval
N/A
Battery life
 10 to 20 years of battery life
Neurostimulator case
10 cc Titanium
MRI labeling
1.5 T and 3 T Full-Body Coil MRI
Stimulation type
Constant current

Axonics R20

Type
Rechargeable
Recharging interval
Every 6 to 10 months
Battery life
20+ years
Neurostimulator case
5 cc Titanium-ceramic
MRI labeling
1.5 T and 3 T Full-Body Coil MRI
Stimulation type
Constant current

Ordering information

 

Product DescriptionUPN
Clinician Programmer2501
Non-Rechargeable F15 Neurostimulator4101
Rechargeable R20 Neurostimulator5101
Tined Lead1201
Tined Lead Implant Kit1801
Remote Control2301
Charging System1401
External Trial Stimulator1601
PNE Lead Implant Kit1701
PNE Lead1901
Percutaneous Extension9009
Stimulation Ground Cable 6PK9003
Torque Wrench 10PK9004
Needle Test Stimulation Cable - box of 69006
Tined Lead Stimulation Cable - box of 69007
Dilator and Sheath - box of 69011
Power Supply9015
Foramen Needle, Long - box of 69001-L
Foramen Needle, Short - box of 69001-S
Curved Belt Extended9108-E
Curved Belt Regular9108-R

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Assessing your patients for sacral neuromodulation

Urinary or bowel dysfunctions can be a difficult topic for patients to discuss. Establishing an easy way to assess whether your patients are suffering from these conditions can help identify their needs. Incorporate a bladder and bowel health assessment into your regular exams and help your patients discuss their symptoms with you.

Guiding your patients through the care pathway

First- and second-line treatments may not always provide the symptom relief your patients are seeking to improve their quality of life. Patients may attempt conservative treatment options, but if symptom improvement is not adequate, they may become discouraged and not seek further treatment, especially if they are not aware that there are other advanced treatment options available. 

Educating your patients about the care pathway may help motivate them to stay engaged in their treatment and to follow up if symptoms are not improved.

Download the patient care pathway PDF

Questions?

We are here to help answer any questions you may have about Axonics SNM.


Reference:

  1. 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. Neurourol Urodyn. 2021;40:714–721.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician trained in use of surgical mesh for repair of stress urinary incontinence.

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