Axonics Sacral Neuromodulation System™ Therapy

Axonics SNM therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Axonics SNM therapy for bowel control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. 

The Axonics SNM System is contraindicated for the following patients: 

• Patients who have not demonstrated an appropriate response to test stimulation; or
• Patients who are unable to operate the Axonics SNM System.

For implanted system: The implanted Axonics SNM System is an MRI conditional system. Refer to “MRI Guidelines for the Axonics Sacral Neuromodulation System” for more information. 

For trial system: An MRI should not be conducted on an individual undergoing a trial period of SNM therapy utilizing the external Trial Stimulator. 

Diathermy - Shortwave diathermy or microwave diathermy CANNOT be performed on patients implanted with the Axonics SNM System. Diathermy can transmit energy through the implanted system, potentially causing tissue damage at the accessory location or the implanted electrodes, resulting in severe injury. 

Microwave ablation – Microwave ablation uses a thin probe that emits microwave energy to heat and destroy unwanted tissue. Microwave ablation CANNOT be performed on the Axonics SNM System as safety has not been established. Microwave ablation may interact with the Axonics SNM System, which can result in unintended tissue damage, device malfunction, or device damage. 

Patients should consult their physician prior to conducting other procedures.

Electromagnetic interference is energy generated by equipment found at home, work, or in public that can interfere with the function of the Axonics SNM System. The Axonics SNM System includes features that provide protection from EMI so that most electrical devices encountered in a normal day are unlikely to affect the operation of the Neurostimulator. While everyday electrical devices are unlikely to affect the Neurostimulator, there are strong sources of EMI that may temporarily affect the operation of your Neurostimulator, including anti-theft detectors found in stores used to detect stolen merchandise. If patients encounter any of these electrical devices, they should walk as far away from the sides of the anti-theft detector when passing through.  

At the Airport, Courthouses, etc.

If patients encounter walkthrough metal detectors or security archways, they should walk-through at a normal pace. These detectors should not affect the Neurostimulator. Hand-held security wands should be passed over the Neurostimulator quickly and should not affect the Neurostimulator. Full-body security scanners (millimeter wave scanners) are used by the Transportation Security Administration (TSA) and are considered safe in patients that have a Neurostimulator. 

Additionally, patients should minimize their exposure by not lingering in the immediate area of the security systems. Some anti-theft detectors may not be visible. If patients feel poorly, they should walk away from the area and anti-theft detectors and security scanners. 

The Neurostimulator contains battery chemicals that could cause severe burns if the Neurostimulator case were ruptured or pierced.

If the Axonics device is implanted close to other implanted devices that have sensing functions, such as cardiac devices, other Neurostimulators, and implantable glucose monitors/insulin pumps, it may cause sensing problems and/or unintended device response in the sensing device. Before surgery, potential interference should be investigated by clinicians involved with both devices. The devices may need to be reprogrammed to provide maximum benefit from both devices. 

The communication performance of Axonics SNM system is unlikely to be affected by other implanted devices. Axonics SNM System’s communication may interfere with other devices’ communication. Avoid programming the two implant devices simultaneously.  

Do not place the charging device of the SNM system adjacent to other implant devices. 

Axonics SNM System Interaction with Implanted Cardiac Devices 

When an Axonics SNM System is co-implanted with an implanted cardiac device (for example, a pacemaker, Cardiac Resynchronization Therapy-Pacemaker (CRT-P), Implantable Cardioverter-Defibrillator (ICD), or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)), the performance of Axonics SNM system is unlikely to be affected by the cardiac device.  

The Axonics SNM System stimulation pulses may interact with the cardiac sensing activity, leading to unintended behavior of the cardiac device. Axonics recommends the following to reduce or prevent potential interference:  

• The devices should be implanted on opposite sides of the body and as far away from each other as possible. 
• If possible, reduce the cardiac device sensitivity. 
• For cardiac devices implanted at standard pocket locations (Sub-clavicular region and Pectoral region): 
  • Axonics bipolar stimulation is unlikely to interfere with cardiac bipolar sensing with a separation of 8 cm or greater. 
  • Axonics bipolar stimulation is unlikely to interfere with cardiac unipolar sensing with a separation of 16 cm or greater. 
  • Axonics monopolar stimulation is unlikely to interfere with cardiac bipolar sensing with a separation of 12 cm or greater. 
  • The Axonics SNM System should not be used in monopolar mode with a cardiac device using unipolar sensing due to a high risk of interference resulting in degradation in performance of the cardiac device. It is recommended at least one of the devices be operated in bipolar mode to reduce the likelihood of interference. 

These potential interactions should be discussed by the patients’ physicians involved with both devices (such as the cardiologist, electrophysiologist, urologist, and urogynecologist). 

Axonics SNM System Interaction with Other Implanted Neurostimulators 

An Axonics SNM System should be co-implanted with a separation distance of 20 cm (8 in) from other implanted Neurostimulator devices (for example, a Deep Brain Stimulator (DBS), Spinal Cord Stimulator (SCS), Vagus Nerve Stimulator (VNS) or stimulators to treat sleep apnea). The performance of Axonics SNM system is unlikely to be affected by the other Neurostimulator with a separation distance of 20 cm (8 in). 

The Axonics SNM System stimulation pulses may interact with the other implanted Neurostimulator’s sensing activity to electrical signals, leading to unintended behavior of the other Neurostimulator. Axonics recommends the following to reduce or prevent potential interference:  

• The devices should be implanted on opposite sides of the body and as far away from each other as possible. 
• If possible, reduce the other Neurostimulator’s sensitivity to electrical signals. 
• If possible, avoid using unipolar sensing on the other Neurostimulator device at the same time as monopolar mode on the Axonics SNM system. 
• These potential interactions should be discussed by the patients’ implanting physicians involved with both devices (such as the neurologist, electrophysiologist, urologist, and urogynecologist). 

Axonics SNM System Interaction with Glucose Monitoring Devices and Insulin Pumps 

Glucose monitoring systems use enzymatic electrochemical reaction for signal sensing, which is different than electric stimulation on the sacral nerve for an SNM system. The Axonics SNM system is unlikely to be affected by Glucose Monitoring Devices and Insulin Pumps.  

The potential interactions should be discussed by the patients’ physicians managing each device. Refer to the user manuals of the Glucose Monitoring Device and Insulin Pump for more information. Do not place the charging device of the SNM system over the Glucose Monitoring Device/Insulin Pump.

If swelling or redness occurs near the Charger attachment site, the patient should contact their clinician before using the Charger again. Swelling or redness may indicate an infection.

Clinician training

Implanting clinicians should be trained on the implantation and use of the Axonics SNM System.

Prescribing clinicians should be experienced in the diagnosis and treatment of lower urinary tract symptoms and should be trained on the use of the Axonics SNM System.

Use in specific populations

The safety and effectiveness of this therapy has not been established for:

• Pregnant women, the unborn fetus, and during delivery
• Pediatric use (patients under the age of 16); for Australia, Neurostimulator Models 4101 & 5101 (patients under the age of 18)
• Patients with neurological disease origins, such as multiple sclerosis and diabetes
• Bilateral stimulation

Clinician training

Implanting clinicians should be trained on the implantation and use of the Axonics SNM System.

Prescribing clinicians should be experienced in the diagnosis and treatment of lower urinary tract symptoms and should be trained on the use of the Axonics SNM System.

Use in specific populations 

The safety and effectiveness of this therapy has not been established for:

• Pregnant women, the unborn fetus, and during delivery
• Pediatric use (patients under the age of 18)
• Patients with neurological disease origins, such as multiple sclerosis and diabetes 
• Bilateral stimulation

Parameter Adjustment – The steps below should be taken to prevent sudden stimulation changes that lead to an uncomfortable jolting or shocking feeling:

• Stimulation parameters should be changed in small increments.
• The stimulation amplitude should be allowed to ramp to full amplitude slowly.
• Before disconnecting the stimulation cable or turning the simulation ON or OFF, the stimulation amplitude should be decreased to 0.0 mA. 

Sensitivity to Stimulation – Some patients, especially those that are very sensitive to stimulation, may be able to sense the telemetry signals associated with reprogramming. 

Programmer Interaction with a Cochlear Implant – Patients with cochlear implants should keep the external portion of their cochlear implant as far from the Clinician Programmer (CP) or Remote Control as possible to minimize unintended audible clicks or other sounds.

Telemetry Signal Disruption from EMI – The Neurostimulator should not be programmed near equipment that may generate electromagnetic interference (EMI) as the equipment may interfere with the CP or Remote Control’s ability to communicate with the Neurostimulator. If EMI is suspected to be interrupting programming, the CP or Remote Control and the Neurostimulator should be moved away from the likely source of EMI.

Interference during medical imaging – The Trial Stimulator should be turned off, disconnected, and removed prior to medical imaging (x-ray, CT). The components of the trial system may distort images or impede the ability to see certain internal structures when performing imaging tests. 

Patients may encounter additional medical procedures and equipment that generate EMI. These medical procedures and equipment are unlikely to affect the Axonics SNM System if the precautions and guidelines are followed: 

Bone Growth Stimulators – The external coils of bone growth stimulators should be kept at least 45 cm (18 in) away from the Axonics SNM System. Do not use a bone growth stimulator if it is not working as intended. 

Dental Drills and Ultrasonic Probes – The drill or probe should be kept 15 cm (6 in) away from the Neurostimulator. The stimulation should be turned OFF.

Diagnostic ultrasound – Ultrasound imaging (sonography), utilizing reflection of acoustic waves to visualize anatomical structures inside body, is unlikely to affect Axonics SNM System. Potential image distortion may be present near implant site. 

Electrical Muscle Stimulation (EMS) – EMS, also known as neuromuscular electrical stimulation (NMES), is a treatment to deliver electrical impulses to motor nerves and cause muscle contraction. The Axonics SNM stimulation should be turned OFF during EMS treatments.

Electrolysis – The electrolysis wand should be kept at least 15 cm (6 in) away from the Neurostimulator. The stimulation should be turned OFF.

Electromagnetic Field Devices – The following equipment or environments should be avoided, or patients should exercise caution around: 

• Antenna of citizens band (CB) radio or ham radio  
• Electric arc welding equipment 
• Electric induction heaters such as those used in industry to bend plastic 
• Electric steel furnaces 
• High-power amateur transmitters  
• High-voltage areas (generally safe if outside the fenced area) 
• Linear power amplifiers 
• Magnetic degaussing equipment 
• Magnets or other equipment that generates strong magnetic fields  
• Microwave communication transmitters (generally safe if outside the fenced area) 
• Perfusion systems 
• Resistance welders 
• Television and radio transmitting towers (generally safe if outside the fenced area)  

Electrosurgery - Electrosurgery uses radio frequency (RF) energy powered electric probe to control bleeding, cut tissue or remove unwanted tissue. A typical electrosurgery system consists of an RF generator and RF electrodes. If electrosurgery is required on patients with an implanted Axonics SNM System, please note the guidelines and precautions:

Before the electrosurgery procedure 

1. Determine the Axonics SNM System implant location (via X-ray, or patient record).
2. Turn the Axonics SNM System stimulation OFF. 

During the electrosurgery procedure

Use a bipolar electrosurgery system, if possible. Follow these guidelines if bipolar electrosurgery is used.

1. Apply bipolar electrosurgery at least 5 cm (2 in) away from the Axonics SNM System (Stimulator and lead).
2. Maximum allowable RF power is 70 W. 

If a monopolar electrosurgery system is used, following these guidelines:

1. Apply monopolar electrosurgery at least 5 cm (2 in) away from the Axonics SNM System.
2. Place the electrosurgery return pad as far away from the Axonics SNM System as possible. It is recommended to be at least 20 cm (8 in) away from the Axonics SNM System.
3. The RF current path is generated between the electrosurgery electrode and return pad. Keep the RF current pathway at least 5 cm (2 in) away from the Axonics SNM System. 
4. Use short and intermittent bursts at the lowest clinically appropriate energy levels.
5. The maximum allowable RF power is 120 W.

After the electrosurgery procedure

Turn the Axonics SNM System stimulation back ON. Verify that the patient has not experienced any adverse effects as a result of the electrosurgery. The patient should contact their physician if they suspect any unexpected change in stimulation.  

Please note the additional warnings:

• Using electrosurgery with the Axonics SNM System can have potential risks of unintended tissue damage, device malfunction, and lead or device damage. These risks can be mitigated if the procedure is used as intended and the guidelines in this document are followed.
• The guidelines are intended for a patient with a fully implanted Axonics SNM System. Electrosurgery should not be performed on a patient undergoing an external trial of sacral neuromodulation therapy.
• After electrosurgery, allow a 1-hour cooling period prior to MR scans. 

Electrocautery – Electrocautery is typically a small, battery-operated, pen-shaped device. It uses DC current to heat an instrument which is applied to tissue to create a cutting/coagulation effect. The current passes through the instrument only and not through the patient’s tissue.

Prior to using electrocautery, turn the Axonics SNM System stimulation OFF. The electrocautery should be performed 5 cm (2 in) away from the Axonics SNM system. After electrocautery, allow a 1-hour cooling period prior to MR scans.

NOTE: The term electrocautery is often used incorrectly to refer to electrosurgical devices. 

External Defibrillator/Cardioversion – External defibrillators restore normal cardiac rhythm by sending electric pulse shocks to the heart through electrode pads on the chest. 

• For a scheduled cardioversion procedure, the Axonics SNM System stimulation should be turned OFF.  
• For a defibrillation procedure that needs to be performed immediately, the patient should contact their physician after defibrillation, if they suspect any unexpected change in stimulation.

High Intensity Focused Ultrasound (HIFU) – HIFU is a therapeutic application using focused acoustic waves to ablate tissue. Unwanted heating on device/tissue interface or device malfunction is unlikely if the guidelines below are followed:

Prior to starting the procedure, the stimulation from the Axonics SNM System should be turned OFF. The HIFU beam should not be directed at the Neurostimulator, and the HIFU transducer edge should be kept at least 5 cm (2 in) away from the Neurostimulator.  

Hyperbaric Chambers - Entering a chamber above 403 kPa (4 atm) total pressure and for longer than 60 minutes should be avoided. Patients should discuss the effects of high pressure with their physician before using a hyperbaric chamber. Patients should not use a hyperbaric chamber during their trial stimulation period.

Ionizing Radiation Diagnostic Imaging – The following ionizing radiation based diagnostic imaging procedures are unlikely to affect the Axonics SNM System:

• X-Ray Imaging
• Computed Tomography (CT) 
• Mammography
• Positron Emission Tomography (PET)/CT
• Bone scintigraphy
• Bone density scan (DEXA) 
• Fluoroscopy

Ionizing Radiation Therapy – Neurostimulator operation may be affected by high-radiation exposure. Sources of high radiation should not be directed at the Neurostimulator. Neurostimulator damage due to high-radiation exposure may not be immediately evident, and exposure should be limited using appropriate measures, including shielding and adjusting the beam angle to avoid exposure to the Neurostimulator. 

Laser Procedures – The laser should not be directed at the Neurostimulator. The stimulation should be turned OFF. 

Lithotripsy – Lithotripsy uses repeated high energy ultrasound shockwaves to break down stones or other calculi into smaller stones that can be passed out of the body. Physical damage to the Axonics SNM System from lithotripsy is unlikely if the guidelines below are followed:

• The Axonics SNM System should be kept away from the beam path and at least 5 cm (2 in) from the focal zone.
• It is recommended that the therapy be delivered from ventral/ventrolateral location when possible. 

Magnetoencephalography (MEG) – MEG measures the neuron activity in the brain by sensing very small magnetic fields. Because MEG does not emit electromagnetic fields, it is unlikely to affect the Axonics SNM System. The stimulation should be turned OFF to minimize the interference of the MEG measurement.

Magnetic therapy, medical magnets, mattress with static magnets, etc. – The static magnet in these applications is unlikely to affect the Axonics SNM System. 

Nerve Conduction Study (NCS) and Electromyography (EMG) – NCS and EMG can be used to evaluate the peripheral nervous system performance. The Axonics SNM stimulation should be turned OFF during NCS or EMG measurements.

Pelvic Floor Muscle Stimulator using pulsed magnetic field (e.g. Emsella® chair) - The Axonics SNM stimulation should be turned OFF during the pelvic floor muscle stimulator treatment.

Psychotherapeutic Procedures – Equipment used for psychotherapeutic procedures may induce electrical currents which may cause heating at the lead electrodes and could result in tissue damage. Equipment that generates electromagnetic interference (e.g., electroconvulsive therapy) during psychotherapeutic procedures have not been established as safe to operate in a patient with a Neurostimulator. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 

Physiotherapy Ultrasound – Physiotherapy ultrasound is used to provide mild heating to inner tissue for physiotherapy treatment. There are risks of unwanted tissue heating and possible device malfunction.  

Prior to the start of the procedure the stimulation should be turned OFF. It is also recommended that physiotherapy ultrasound beam should not be directed at the Neurostimulator, and the transducer edge should be kept at least 5 cm (2 in) away from the Neurostimulator. 

Pulsed ElectroMagnetic Field (PEMF) devices – PEMF devices have not been evaluated. Using PEMF devices with the Axonics SNM System has potential risks for unintended stimulation, device heating, and device damage.