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

Abstract

BACKGROUND AND STUDY AIMS\nA medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We 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 in symptomatic epiphrenic esophageal diverticulum (EED).\n\n\nMATERIALS AND METHODS\nThe MAGUS was designed based on previous knowledge of compression anastomosis and current 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.\n\n\nRESULTS\nAnimal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure.\n\n\nCONCLUSIONS\nThis new system provides a way to perform 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.