US -based GT Metabolic Solutions receives de novo marketing authorization for novel magnet compression anastomosis technology

Michel Gagner, MD, pioneer in magnetic compression anastomosis surgery

GT Metabolic Solutions, a company dedicated to reinventing bariatric, metabolic, and digestive surgery, today announced its first-generation MagDI System for side-to-side duodeno-ileal anastomosis was granted De Novo marketing authorization from the US FDA.
Traditional anastomotic devices like staples or sutures can be difficult to apply in confined spaces during minimally invasive surgical procedures and can cause trauma by cutting or piercing the bowel tissue and leaves foreign material behind. Magnetic compression anastomosis is designed to: mitigate the need for incision to the bowel, reduce user technical variability during a procedure, and be naturally excreted from the body.

"Side-to-Side Magnetic Duodeno-Ileostomy in Adults with Severe Obesity with or without Type 2 Diabetes: Early Outcomes with Prior or Concurrent Sleeve Gastrectomy in the journal Surgery for Obesity and Related Diseases" was published in November 2023 in the ASMBS journal for Surgery for Obesity and Related Diseases (SOARD). Future planned studies may be able to broaden improvements in patient outcomes and potentially reach more patients with this less invasive anastomotic approach.

Michel Gagner, MD, and Co-Founder of GT Metabolic said, "Magnetic compression anastomosis is designed to allow for more consistent tissue alignment, central necrosis, and circumferential healing while leaving no foreign materials behind to impede the natural tissue healing process."