Efficacy and safety of the remOVE System for OTSC(®) and FTRD(®) clip removal: data from a PMCF analysis.

AbstractIntroduction: The remOVE System (Ovesco Endoscopy AG, Tuebingen, Germany) is a medical device for the endoscopic removal of OTSC or FTRD clips (Ovesco Endoscopy AG, Tuebingen, Germany). The aim of this paper is to assess the efficacy and safety of this system.Material and methods: A total of 74 patients underwent clip extraction. The standard removal procedure comprises fragmenting the clip by applying an electrical direct current pulse at two opposing sides of the clip.Results: Clip fragmentation was successful in 72 of 74 patients (97.3%). In two cases (2.7%) clip fragmentation was not possible. In nine cases (12.2%) a clip fragment could not be removed and was left in place. Complications occurred in three cases (4.1%): two minor bleedings near the clip removal site (2.7%), and one superficial mucosal tear resulting from clip fragment extraction (1.4%).Discussion: Based on this study, the use of the remOVE System for OTSC or FTRD clip removal can be considered safe and effective.