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 11 sources, which was discussed by the committee. The evidence included 1 systematic review, 1 pooled analysis of 4 trials, 1 randomised controlled trial (described in 2 publications and also included in the pooled analysis), 1 prospective multicentre single-arm trial (described in 2 publications and also included in the pooled analysis), 1 retrospective cohort study, 1 retrospective non-randomised comparative study, 2 retrospective case series, and a report from the US Food and Drug Administration Manufacturer and User Facility Device Experience database. The evidence is presented in the summary of key evidence section in the overview. Other relevant literature is in table 5 of the overview.