2.1
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 2 systematic reviews, 1 retrospective cohort study, 4 randomised controlled trials, 1 prospective cohort before-after study, 2 case reports and a report from the Food and Drug Administration Manufacturer and User Facility Device Experience registry. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
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