3.1
NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 10 sources, which was discussed by the committee. The evidence included 1 Cochrane review, 1 meta-analysis, 3 randomised controlled trials, 1 three‑arm randomised trial and 4 case series (registries). It is presented in the summary of key evidence section in the overview. The committee also considered additional confidential documentation provided by a company.