Magnets and a self-retractable wire for endoscopic septotomies: from concept to first-in-human use

Abstract

Background: A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We have developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device for the treatment of symptomatic epiphrenic esophageal diverticulum (EED).

Methods: The MAGUS (MAgnetic Gastrointestinal Universal Septotome) device was designed based on previous knowledge of compression anastomosis and currently unmet needs. After initial design, the feasibility of the technique was tested on artificial septa in pigs. A clinical trial was then initiated to assess the feasibility and safety of the technique.

Results: Animal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with a symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure.

Conclusions: This new system provides a way of performing endoluminal septotomy in a single procedure. It appears to be effective and safe for managing symptomatic EED. Further clinical applications where this type of remodeling of the GI tract could be beneficial are under investigation.

Trial registration: ClinicalTrials.gov NCT04480216.

Conflict of interest statement

Daniel Blero, Nicolas Cauche, Cécilia Delattre, Alain Delchambre, Jacques Deviere, Sonia Dugardeyn, François Huberland, and Ricardo Rio Tinto are the inventors of and holders of a patent on the MAGUS device. The remaining authors declare that they have no conflict of interest.

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Figures

Fig. 1

Diagram showing the system of magnets and wire that are used to cut the septum of the diverticulum, achieving a marsupialization. Both the magnets and the wire cut by applying a continuous pressure inducing pressure necrosis and wound healing with fibrosis.

Fig. 2

Diagrams showing:athe spatial arrangement of the MAGUS magnetic device, which consists of a single magnet (blue), a self-retractable wire (green), and magnetic box (casing shown in black) that contains the winding system (orange) and two further magnets (blue);bthe MAGUS delivery system used during the clinical trial allows distal attachment/proximal release of the single magnet (1a/1b) and distal attachment/proximal release of the magnetic box (2a/2b), with the self-retractable wire being activated when the magnetic box is released.

Fig. 3

The steps in the delivery of the MAGUS system are:ainsertion of the device;bmobilization of the proximal magnet;cpulling of the catheter;dthe meeting of the magnets;erelease of the distal magnet and activation of the self-retractable wire.

Fig. 4

Diagrams and photographs from pig #4 showing:aimplantation of the MAGUS device (external picture, with internal and cut-view schematics);bthe resulting cut (the yellow circle shows the cutting line);cmacroscopic histological view;dmicroscopic histological view, with fusion of the layers and new mucosa growing on top and no significant fibrosis present.

Fig. 5

Images from the first patient showing:a,bthe implanted device:aat the end of the intervention endoscopic;bon radiological view;c,dbarium swallow from:cbaseline;d3 months after insertion of the MAGUS, with almost complete disappearance of the septum.