This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Axonics Sacral Neuromodulation System
PMA Applicant: Axonics Modulation Technologies, Inc.
Address: 26 Technology Drive, Irvine, CA 92618
Approval Date: September 6, 2019
Approval Letter: Approval Order

What is it? The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat bowel (fecal) incontinence using mild electrical pulses.

How does it work? When permanently implanting the Axonics SNS System, the (Implantable Pulse Generator, IPG) is inserted in the lower back between the two hipbones of the pelvis. The IPG will send mild electrical pulses to the nerves that travel from the spinal cord to muscles in the pelvis (sacral nerves) to help restore bowel control.

When is it used? The Axonics SNM System for bowel control is indicated for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for other treatments, such as medications or physical therapy. If left untreated, fecal incontinence can reduce a patient's quality of life and can result in significant challenges in maintaining activities of daily living.

What will it accomplish? The results compiled from a systematic literature review available for a similar SNM device show that there is benefit for patients with fecal incontinence who have failed or are not candidates for other treatments such as medications or physical therapy. In one of the studies (Hull, 2013), 120 out of 133 patients underwent a test stimulation and received the implant. These 120 patients were followed for 5 years. At 5 years, 89% (64/72) of patients had at least a 50% improvement and 36% (26/72) of patients at 5 years were able to control their bowel and bladder movements (total continence). The average number of weekly incontinent episodes decreased from 9.1 at baseline to 1.7 at 5 years. In addition, improvements in all four (4) scales of the Fecal Incontinence Quality of Life (FIQL) questionnaire from baseline to 5 years were statistically significant. Given the similarities in design, technology, performance, indication for use, output characteristics and patient population, it is meant to treat, FDA believes that the Axonics device will have similar performance to the commercially available SNM system evaluated in the studies.

When should it not be used? The Axonics SNM System should not be used in:

• Patients who have not demonstrated an appropriate response to test stimulation; or
• Patients who are unable to operate the neurostimulator

Additional information (including warnings, precautions, and adverse events)

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling
• Physician Labeling
• PMA Database Entry