2.1 Axonics sacral neuromodulation (SNM) system stimulates the sacral nerve through an implantable pulse generator implanted subcutaneously in the upper buttock. Lead electrodes implanted through the corresponding sacral foramen transmit pulses from the stimulator to the sacral nerves. The stimulator is powered by a rechargeable battery.
A handheld remote control activates the stimulator, adjusts the stimulation amplitude, and checks the battery status. A wireless charger, attachable to the skin over the implanted stimulator, is used to charge the stimulator. The company claims that the battery needs recharging every 1 to 2 weeks for 30 minutes to 1 hour. The implanted device is programmed by a clinician in an outpatient setting using a portable tablet. Axonics SNM system received a CE mark as a class 3 medical device in June 2016.
2.2 The rechargeable battery that powers the stimulator has an expected life span of at least 15 years, which the company claims is longer than the comparable non-rechargeable device. The stimulator is compatible with MRI and is smaller than existing non-rechargeable SNM devices, making it more suitable for people with a low body mass index.
2.3 The Axonics SNM system is intended to treat symptoms of overactive bladder, urinary retention and chronic faecal incontinence, specifically when conservative treatment and treatment with medicine have not worked or are not suitable. Urinary retention and faecal incontinence are outside the scope of this evaluation. The decision to treat with SNM therapy using the Axonics SNM system is made by a multidisciplinary team, including surgeons, specialist nurses and physiotherapists, together with the person having the treatment. Axonics SNM system is implanted by surgeons specialising in bladder dysfunction. Limited surgical and patient training is needed.
For more details, see the website for Axonics SNM system.