Axonics™ Sacral Neuromodulation System

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.

Warning: This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

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.

Microwave ablation – Microwave ablation CANNOT be performed on the Axonics SNM System as safety has not been established. 

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 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. 

Avoid programming the two implant devices simultaneously.  

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

These potential interactions should be discussed by the patients’ physicians involved with both devices. 

Axonics SNM System Interaction with Other Implanted Neurostimulators 

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. 

These potential interactions should be discussed by the patients’ implanting physicians involved with both devices. 

Axonics SNM System Interaction with Glucose Monitoring Devices and Insulin Pumps 

The potential interactions should be discussed by the patients’ physicians managing each device. Do not place the charging device of the SNM system over the Glucose Monitoring Device/Insulin Pump.

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)
• 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. 

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

Electrosurgery - Using electrosurgery with the Axonics SNM System can have potential risks of unintended tissue damage, device malfunction, and lead or device damage.

RF Ablation - Using RF ablation with the Axonics SNM System has potential risks of unintended tissue damage, device malfunction, and lead or device damage.

• Implantation and use of the Axonics SNM System incurs risk beyond those normally associated with surgery, some of which may necessitate surgical intervention.  These risks include, but are not limited to the following:
• Adverse change in voiding function (bowel and/or bladder)
• Allergic or immune system response to the implanted materials that could result in device rejections
• Change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients
• Device fracture/failure
• Device migration
• Electrical shock
• Infection
• Pain or irritation at Neurostimulator and/or lead site
• Seroma, hemorrhage, and/or hematoma
• Suspected lead or Neurostimulator migration or erosion
• Suspected nerve injury (including numbness)
• Suspected technical device malfunction
• Transient electric shock or tingling
• Unintended nerve activation
• Heating or burn at Neurostimulator site
• Lack of efficacy
• Reoperation/Revision
• Undesirable change in pelvic function