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 eff

SUBMITTER: Bjelovic M 

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

REPOSITORIES: biostudies-literature