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.

• References

• 1 Chan DSY, Foliaki A, Lewis WG. et al. Systematic review and meta-analysis of surgical treatment of non-Zenker’s oesophageal diverticula. J Gastrointest Surg 2017; 21: 1067-1075
• 2 Yang J, Zeng X, Yuan X. et al. An international study on the use of peroral endoscopic myotomy (POEM) in the management of esophageal diverticula: the first multicenter D-POEM experience. Endoscopy 2019; 51: 346-349
• 3 Bouchard S, Huberty V, Blero D. et al. Magnetic compression for treatment of large oesophageal diverticula: a new endoscopic approach for a risky surgical disease?. Gut 2015; 64: 1678-1679
• 4 Disibeyaz S, Saygili F, Oztas E. et al. Endoscopic septotomy of a magnet-induced neoseptum in a large mid-esophageal diverticulum. Endoscopy 2016; 48: E244-E245
• 5 Machytka E, Bužga M, Zonca P. et al. Partial jejunal diversion using an incisionless magnetic anastomosis system: 1-year interim results in patients with obesity and diabetes. Gastrointest Endosc 2017; 86: 904-912
• 6 Graves CE, Co C, Hsi RS. et al. Magnetic compression anastomosis (Magnamosis): first-in-human trial. J Am Coll Surg 2017; 225: 676-681.e1
• 7 Zaritzky M, Ben R, Johnston K. Magnetic gastrointestinal anastomosis in pediatric patients. J Pediatr Surg 2014; 49: 1131-1137
• 8 van Hooft JE, Vleggaar FP, Le Moine O. et al. Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study. Gastrointest Endosc 2010; 72: 530-535
• 9 Huberland F, Sandersen C, Bastin O. et al. Wire and magnet septotome, a new method for endoscopic leak-free section of septa in the GI tract: preliminary result of a pilot animal study. Endoscopy 2019; 51: S172
• 10 Eckardt VF, Aignherr C, Bernhard G. Predictors of outcome in patients with achalasia treated by pneumatic dilation. Gastroenterology 1992; 103: 1732-1738
• 11 Aryaie AH, Fayezizadeh M, Wen Y. et al. “Candy cane syndrome:” an underappreciated cause of abdominal pain and nausea after Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis 2017; 13: 1501-1505
• 12 Dallal RM, Cottam D. “Candy cane” Roux syndrome--a possible complication after gastric bypass surgery. Surg Obes Relat Dis 2007; 3: 408-410