Axonics System

 How does it work?

An implantable pulse generator (IPG) is surgically placed below the skin in the upper buttock area and attached to a lead wire that passes between the hip bones of the pelvis and ends at the sacral nerve. The IPG sends electrical pulses through the lead wire to the sacral nerve that travels from the spinal cord to the bladder to help improve urinary control.

When is it used?

The Axonics SNM System for urinary control is used for the treatment of urinary retention and the symptoms of overactive bladder in patients who have failed or could not tolerate other treatments, such as lifestyle changes, pelvic floor exercises, or medication. If left untreated, urinary retention and overactive bladder 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 from a clinical study of the Axonics SNM System combined with additional clinical data compiled from a systematic review of literature available for a similar SNM device show that there is benefit for most patients with urinary retention and the symptoms of overactive bladder who have failed or could not tolerate other treatments.

In the Axonics clinical study of patients with urge urinary incontinence, 90% (116/129) of patients with the implanted SNM System achieved at least a 50% reduction in the number of urgency leaks at 6 months compared to the number of urgency leaks without the SNM System. In a longer-term study (van Kerrebroeck, 2007), 152 patients implanted with a similar SNM device were followed for 5 years. At 5 years, 58% (56/96) of patients with urge urinary incontinence had at least a 50% improvement (measured in terms of the number of leaks per day). Additionally after 5 years, 40% (10/25) of patients with urgency-frequency had at least a 50% improvement (measured in terms of the number of voids per day), and 58% (18/31) of patients with urinary retention had at least a 50% improvement (measured in terms of the number of catheterizations per day).

Given the similarities in design, technology, performance, indications for use, output characteristics and the patient population it is meant to treat, FDA believes that the Axonics SNM System will have similar performance to the commercially available SNM system evaluated in the published studies.