Summary

Summary

  • The technology described in this briefing is Axonics sacral neuromodulation (SNM) system. It is intended for use in faecal incontinence.

  • The innovative aspects are that it is designed to need less frequent surgical replacement than the comparable non-rechargeable device currently used as standard care.

  • The intended place in therapy is as an alternative to non-rechargeable SNM devices in people with faecal incontinence, who would be offered SNM in line with current NICE guidelines.

  • The main points from the evidence summarised in this briefing are from 2 single-arm observational studies and 1 case series involving a total of 62 people with faecal incontinence. They show that Axonics SNM system may be effective, and that most people were satisfied with rechargeable therapy. Axonics SNM system was not compared with any other treatment.

  • Key uncertainty around the technology is that the available evidence is limited in quantity and quality. Well-designed, comparative studies with larger numbers of people and longer follow up would be helpful to confirm equivalence to standard care in people with faecal incontinence.

  • The cost of Axonics SNM system is £475 for the trial phase, £10,160 for a permanent implant and £7,000 for a replacement implant (all excluding VAT). A standard non-rechargeable SNM device costs up to around £10,000 depending on the type of temporary stimulation used and around £6,000 for a replacement implant (all excluding VAT).