Important Safety Information

Indications:
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.

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 Systems.

Warnings:
Axonics SNM Therapy is not intended for patients with urinary mechanical obstructions. 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 minimize 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 to the use of 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 Systems. 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 Systems.
The safety and effectiveness of Axonics Therapy has not been established for use in pregnant women, the unborn fetus, and during delivery, for pediatric patients (under the age of 18 years for FI and under the age of 16 years for OAB and UR), for patients with neurological disease origins, such as multiple sclerosis or diabetes, or for bilateral stimulation.

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, 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, and undesirable change in pelvic function.

Caution: Federal law (USA) restricts this device to sale by, or on the order of, a physician.

Important Safety Information

IMPORTANT SAFETY INFORMATION:

Indications:Axonics SNM Therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency, either 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 faecal incontinence. The therapy should only be used in patients who have failed or are not candidates for more conservative treatments.

Contraindications: The Axonics SNM System 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:
This therapy is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

Implantation and use of the Axonics System incurs risk beyond those normally associated with surgery, some of which may necessitate surgical intervention. These risks include but are not limited to adverse change in voiding function (bowel and/or bladder), infection, pain or irritation at the implant site, lead or device migration, electrical shock, change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients, and heating or burns at the device site.

Results and experiences may vary and are unique to each patient. No promise or guarantee is made about specific results or experiences. Talk to your doctor about whether the Axonics System is right for you and to discuss the potential risks and benefits.

For more information about safety and potential risks, refer to Information for Prescribers and Patients at www.axonics.com/eIFU.

Precautions:
The safety and effectiveness of the Axonics System has not been established for use in women who are pregnant or in delivery; for pediatric patients (under the age of 18 years for faecal incontinence and under the age of 16 years for overactive bladder and urinary retention); for patients with neurological disease origins, such as multiple sclerosis or diabetes; or for bilateral stimulation.

Caution: This device can be sold and used by, or on the order of, a physician only. For Summary of Safety and Clinical Performance (SSCP), refer to https://ec.europa.eu/tools/eudamed/#/screen/home.

Adverse Event Reporting

In case of any serious incident related to the product, please report to Axonics (+1-877-929-6642) as well as the competent authority of your state, which can be found here: https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human.

Questions?

We are here to help answer any questions you may have about the Axonics System and Therapy.