GT Metabolic Solutions gains CE mark for GT Metabolic Magnet System

GT Metabolic Solutions has received CE certification (CE Mark) under the EU Medical Device Regulation (EU MDR) that enables commercialisation of the GT Metabolic Magnet System across the European Economic Area (EEA).

GT Metabolic achieved successful review and certification of the GT Metabolic Magnet System for side-to-side enteroenterostomy (40mm, 50mm Magnets; throughout the small bowel) and gastroenterostomy (60mm, 70mm Magnets; stomach to small bowel), the first integrated system providing different size tools for magnetic anastomosis, allowing the surgeon to choose length of magnet for the specific patient and clinical procedure.

“It is exciting to bring magnetic compression anastomosis to the European market and see how surgical innovators will quickly use and expand the technology in their clinical practices,” explained GT Metabolic Chief Medical Officer and co-founder, Professor Michel Gagner. “Gaining CE mark approval is very important – not only is it important for Europe with approval in over 40 countries - but there are also other countries and regions that acknowledges CE Mark approval such as Australia, North Africa, Mexico and Brazil. Prior to the CE Mark, we had approval in about 18 countries, now we have approval in over 60 countries.”

Professor Michel Gagner

Professor Gagner said the company will start a gradual launch of the GT Metabolic Magnet System in September 2026. The launch will involve a significant proctoring schedule starting in September in several centres, with a strong emphasis on proctoring and training to ensure proper patient selection, equipment usage and OR team education.

“The gradual roll-out of the device requires careful planning to ensure surgeons and the OR team receive full and comprehensive training on how to use the device, as well as educating them on correct patient selection and ensuring the equipment that is required is correct and in place for them to perform the procedure/s. So, we are planning a significant expansion of our proctoring schedule for the rest of the year, starting September. We have distributors now for Italy, Spain, Portugal, UK, Romania and Poland, and we hope to finalise addition distributors in countries such as France and the Benelux region.”

The CE mark approves the device as an anastomotic device, not specifically for bariatric surgery. It is approved for small bowel-to-small bowel and stomach-to-small bowel anastomoses. While bariatric surgery is a key important market, the magnets extend beyond primary procedures to various bariatric revisions (e.g., shortening Roux-en-Y gastric bypass, reversal of gastric bypass, addressing candy cane syndrome, elongation for duodenal switch/SADI etc). In addition, the smaller magnets (40mm, 50mm) can be used to treat conditions such as superior mesenteric artery syndrome, ileostomy, stomach closure and high-grade fistulas (between the skin and intestine).

“The 60mm and 70mm magnets are used to create the larger anastomosis, this is because there's a stronger contraction of the wound because the wall is thicker, more muscular and if you make the anastomosis too small at the start, it will shrink , potentially leading to stenosis. These larger magnets allow us to get the anastomosis right the first time, avoiding subsequent interventions such as balloon dilation.”

Professor Gagner believes that these larger magnets will create new treatment opportunities in surgical oncology for the palliation of pancreatic, duodenal, biliary and ampullary cancers by creating gastrojejunostomies to alleviate gastric outlet obstruction.

“In time, I believe the surgical oncology community in Europe, and beyond, are going to be interested in this technology to palliate the partial gastric outlet obstruction,” he added. “In my opinion, this offers a superior alternative to stents, which can leak or migrate, improving our patient’s quality of life.”

Furthermore, GT Metabolic Solutions is current conducting a multi-centre trial for colorectal surgery that is expected to conclude by the end of summer 2026. Professor Gagner said the preliminary data was “very encouraging” showing no leaks, bleeding or stenosis.

“We think that colorectal is going to be a major game-changer especially in the rectal anastomosis, where there is a higher leak rate than bariatric surgery, in some cases 10 to 20%. The combination of magnetic technology with Indocyanine Green (ICG) to assess blood supply seems to significantly reduce leak rates.”

For more information, please visit: https://gtmetabolic.com/