• The technology described in this briefing is Permacol, a collagen paste that is injected into anal fistulae.

  • The innovative aspect is that, unlike collagen plugs, the paste expands to fill and seal the fistula tract. This is designed to make it less easily expelled when defaecating.

  • The intended place in therapy would be as an alternative to other sphincter-saving surgical techniques used to treat anal fistulae.

  • The main points from the evidence summarised in this briefing are from 5 studies in the UK and Europe including a total of 152 adults. They report that Permacol is a safe treatment for anal fistulae. Large randomised studies are needed to fully assess its healing rates and effectiveness compared with other treatments.

  • Key uncertainties are that the evidence base is still developing and that long-term healing and recurrence rates are unknown.

  • The cost of Permacol is £724.19 per unit, excluding VAT and additional procedure costs. The resource impact may be similar to or less than standard care if the additional device costs were offset by reductions in complications or recurrence, but there is currently no evidence for this.