• The technology described in this briefing is Aptiva. It uses a frequency rhythmic electrical modulation system (FREMS) to treat painful diabetic neuropathy.

  • The innovative aspect of the technology is that it is designed to be a non-drug option for treating painful diabetic neuropathy, with a novel mechanism of action.

  • The intended place in therapy is uncertain. It could be used in addition to, or in place of, current drug treatment options.

  • The main points from the evidence summarised in this briefing are from 4 non-UK-based studies, consisting of 1 randomised controlled trial, 2 randomised double-blind crossover studies and 1 case–control study. The studies include 151 adult patients in an ambulatory care setting. They show that Aptiva can reduce pain and improve quality of life and neurovascular measures compared with placebo in patients with painful diabetic neuropathy.

  • Key uncertainties around the evidence or technology are that there are no studies comparing Aptiva with other available treatment options, and the current evidence is limited in quality and quantity.

  • The cost of Aptiva is £28,750 per unit with an additional cost of £5.46 for consumable electrodes per treatment session (excluding VAT). Additional staff costs associated with administering Aptiva would range between £437.50 and £770 per patient per year. The resource impact would be that it would increase costs compared with standard care in terms of capital cost, consumables and staff time.