Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results : RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark.

ABSTRACT: BACKGROUND:RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS:In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for 1 year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-h pH monitoring, and reduction in average daily PPI usage and subject satisfaction. RESULTS:There were no serious adverse events related to the device. Average GERD-HRQL total score at 1?year improved 86% from baseline (p 

SUBMITTER: Bjelovic M 

PROVIDER: S-EPMC7370422 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature