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 7 sources, which was discussed by the committee. The evidence included 1 systematic review, 1 randomised controlled trial, 3 single-arm trials, 1 case-control study, and 1 analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience database. It is presented in the summary of key evidence section in the overview. Other relevant literature is in the appendix of the overview.