A peer-reviewed study, Sutureless Duodeno-Ileal Anastomosis with Self-Assembling Magnets: Safety and Feasibility of a Novel Metabolic Procedure’, published in Obesity Surgery, has concluded that sutureless duodeno-ileal side-to-side anastomosis using self-assembling magnets is feasible and safe in patients with obesity, and a dual-path enteral diversion with large-calibre and durable anastomosis can be achieved.
The study conducted at Hospital Alemán by lead investigator Dr Rudolf Baron Buxhoeveden and co-investigators Dr Francisco Schlottmann, Dr Marvin Ryou, Dr.Chris Thompson and Dr David Lautz. The aim of the study was to determine the technical feasibility and safety of sutureless duodeno-ileal side-side anastomosis in patients with obesity and type 2 diabetes using self-assembling magnets.
“The GI Windows magnetic compression technology is the first to allow a digestive anastomosis to be performed with the use of a common flexible endoscope without opening the digestive tract, virtually eliminating the risk of postoperative bleeding and fistulas,” said Buxhoeveden. “Our patients need metabolic outpatient procedures and potentially reversible procedures that are safe with minimally-invasive technology; all characteristics that the duodenal-ileal diversion procedure with self-assembling magnets can offer.”
Self-Assembling magnets (GI Window) are a novel sutureless compression anastomosis device that is less invasive, easily delivered, and leaves no permanent foreign body, such as, the conventional anastomosis technology used today. The ileal magnet was deployed laparoscopically and the duodenal magnet was deployed endoscopically. Both magnets were coupled under laparoscopic and fluoroscopic guidance. The primary endpoints were technical feasibility and safety. The secondary endpoints were patency of the anastomosis, HbA1c reduction, and weight loss 12 months after the procedure.
In total, of eight patients were enrolled in the study; median age was 51.5 years (range: 34–65), and median BMI was 38.8 kg/m2 (range: 35–47.9). The mean procedural duration was 63.5 min (range: 41–95). There were no intraoperative complications and no major postoperative morbidity related to the procedure. Magnets were expelled at a median of 29.5 days after the procedure with no associated complications.
Upper endoscopy at 12 months confirmed patent anastomoses with healthy-appearing mucosa in all patients. The researchers noted that HbA1c was reduced below 7.0% in six out of eight (75%) patients and greater than 5% of total body weight loss was observed in seven out of eight (87.5%) patients at 12 months.
“From the beginning we have always believed the promise of magnetic compression in creating a safe, minimally-invasive anastomosis for patients with obesity and T2D,” said GI Widnow’s Chief Medical Officer, Dr Marvin Ryou. “This publication validates the safety and feasibility for self-assembling magnets and the potential to reshape the landscape in metabolic surgery.”
In 2020 the FDA granted Breakthrough Therapy designation on GI Window’s self-assembling magnets, for a small bowel application.