Important Safety Information (Australia)

Indications:
Axonics F15 SNM therapy for urinary control is indicated for the treatment of 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 F15 SNM therapy for bowel control is indicated for the treatment of chronic faecal incontinence in patients who have failed or are not candidates for more conservative treatments.

Axonics R15 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 R15 SNM Therapy for bowel control is indicated for the treatment of chronic faecal incontinence in patients who have failed or are not candidates for more conservative treatments.

Contraindications:
Axonics SNM Therapy is contraindicated for patients who have not demonstrated an appropriate response to test stimulation; or Patients who are unable to operate the Axonics SNM System.

Warnings:
Axonics SNM Therapy is not intended for patients with urinary mechanical obstructions such as benign prostatic hypertrophy, cancer, or urethral stricture. Diathermy cannot be performed on patients implanted with the Axonics SNM Systems. The Axonics SNM Systems are MRI Conditional systems. The following procedures may adversely affect the patient or the Axonics SNM Systems including: Lithotripsy, Monopolar electro surgery, Microwave and Radiofrequency (RF) ablation, Radiation therapy over the Neurostimulator, and Ultrasound or scanning equipment. Electromagnetic interference can interfere with the function of the Axonics SNM Systems. Walkthrough metal detectors, security archways, hand-held security wands should not affect the stimulator. Full-body security scanners are considered safe in patients that have the stimulator. Patients should minimise their exposure by not lingering in the immediate area of security systems. The Neurostimulator, Remote Control and Charger contain batteries with chemicals that can cause bodily harm, including severe burns, if exposed to your body. Do not rupture or pierce the devices or use the device that appears damaged or has visible internal components. If swelling or redness occurs near the Charger attachment site, discontinue the use of the Charger and consult your doctor before using the Charger again.

Precautions:
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 or faecal incontinence and should be trained on the use of the Axonics SNM Systems.

The safety and effectiveness of Axonics Therapy has not been established for use in pregnant women, the unborn fetus, and during delivery, for patients with neurological disease origins, such as multiple sclerosis or diabetes, or for bilateral stimulation. The safety and effectiveness of Axonics Therapy has not been established for use in pediatric patients:

  • F15: under the age of 18 years for both FI and OAB.
  • R15: under the age of 18 years for FI and under the age of 16 years for OAB and UR

Potential Adverse Events:
Implantation and use of the Axonics SNM Systems incur risks 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, heating or burn at Neurostimulator site, infection, lack of effectiveness, pain or irritation at Neurostimulator and/or lead site, reoperation/revision, seroma, haemorrhage, 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, and undesirable change in pelvic function.

Any serious incident that occurs in relation to the device should be reported to both Axonics at customersupport@axonics.com and to the Therapeutic Goods Administration at the TGA website www.tga.gov.au/reporting-problems.

This product is not available for purchase by the general public.