Axonics sacral neuromodulation system for faecal incontinence

Level of innovation

The technology's MRI compatibility and rechargeable battery were identified by the experts as Axonic SNM system's main innovations. However, 1 expert noted that MRI compatibility may be less of an innovation because comparator equipment is now MRI compatible. Three of the experts felt that the rechargeable battery made the Axonics SNM system a minor variation to standard care; 1 of these experts noted that the technology is likely to have equivalent efficacy to the non-rechargeable SNM device currently used as standard care. Three experts noted that a competing technology with MRI compatibility and a rechargeable battery is available but how widely it is used in the NHS was not described.

Potential patient impact

Most of the commentators thought the longer battery life would provide the largest benefit to patients, and that using the new technology would lead to fewer invasive surgeries needed for battery replacement. One expert said that the technology's MRI compatibility would also lead to fewer people needing explanation procedures before having an MRI scan. One commentator said the technology could be thought of as less invasive than standard care but did not believe it would lead to better clinical outcomes overall. Another said that improved clinical outcomes over standard care may only be seen in terms of reduced complications because of the smaller sized implantable pulse generator device.

Three experts said that people needing MRI scans would particularly benefit from the device. Another thought that younger patients would benefit, since the duration of lifetime SNM therapy would be longer compared with older patients. One of the commentators believed that people with a low BMI would also benefit from the technology because of its smaller implant size. People for whom repeated battery changes under anaesthetic would be unsuitable and people who express a preference for a rechargeable device were also identified by 1 expert as those that would benefit from Axonics SNM therapy.

Potential system impact

Fewer operations and hospital visits for battery replacement and explantations were identified as potential system benefits. Two experts thought that the technology would replace current standard care. Two said it would be an additional option to standard care, with 1 noting that not all patients want a rechargeable device and that one is not always suitable. Two commentators said the technology would cost less than current standard care, while 2 thought it would be cost saving in the long term when battery replacement is considered.

All commentators agreed that there would be no need for facility or infrastructure changes to adopt this technology. Product-specific training for people having therapy and staff involved in their care was identified by 1 expert but this was thought to be minimal. Two experts noted that familiarisation with Axonics SNM system equipment (including programming) would be needed by healthcare professionals, but the basic principles of surgery and the procedure are the same as those used in standard care. The remaining expert did not believe specific training would be needed.

General comments

None of the experts were aware of any potential barriers to adoption. The need for long-term follow-up data was identified by 1 expert and 2 others said that head-to-head comparison data of Axonics and the non-rechargeable SNM device currently used as standard care would be helpful.