GT Metabolic Solutions has announced its first-generation MagDI System for side-to-side duodeno-ileal anastomosis has been granted De Novo marketing authorisation from the FDA. 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.
According to the company, 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. Working in tandem with renowned global experts, the company has engineered a magnetic compression solution called delayed anastomosis technology (DAT) that surgeons can use to create consistent anastomosis while helping minimize potential complications, such as leaks and bleeds, in challenging applications. The solution democratises the surgical approach to anastomosis. It can be used in procedure staging and is 100% reversible.
To date, seven peer-reviewed publications have been completed, including most recently a multi-centre clinical consisting of 43 patients conducted by Gagner et al (‘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’: November 2023: SOARD), which demonstrated no anastomotic leaks, bleeds or obstruction in duodeno-ileal side-to-side anastomosis in bariatric and metabolic procedures.
"Creating a secure anastomosis free of complications bleeds or leaks is the goal of any minimally invasive surgical approach," said Dr Michel Gagner and Co-Founder of GT Metabolic. "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. This technology has the potential to offer new standards of care in many procedures. Surgeons are going to like this technology.”
Future planned studies may be able to broaden improvements in patient outcomes and potentially reach more patients with this less invasive anastomotic approach.
"Obtaining Medical Device De Novo Classification to market our platform in just four years following the company's inception is incredible. This was achieved due to the vision of the founders and the focus and leadership of the management team and its investors who support and share our dream to democratize anastomosis technique," said Thierry Thaure, CEO and Co-Founder, GT Metabolic. "The MagDI System offers the concept, for the first time, to democratize the surgical approach to anastomosis, enabling surgeons to potentially achieve a more consistent outcome in a less invasive and potentially less expensive solution. We are looking forward to worldwide launch of our incisionless anastomosis system later this year."
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