FDA Approves GT Metabolic's First-of-Its-Kind MagDI™ System for Duodeno-Ileal Anastomosis

GT Metabolic Solutions has announced that the U.S. Food and Drug Administration has cleared its MagDI™ System for side-to-side duodeno-ileal (DI) anastomosis.

This innovative system perform anastomosis without leaving any foreign materials behind, marking a significant milestone in minimally invasive surgery.

The MagDI™ System is designed to advance magnetic surgery, with the system having already been tested in over 100 cases across seven clinical trials in eight countries.

The system consists of the GT Metabolic linear DI magnets, a delivery system, and a laparoscopic positioning device (LPD).

During the procedure, two linear magnets are delivered into the patient’s stomach and positioned laparoscopically to self-align through the small bowel.

Over the following weeks, the magnets compress the tissue, allowing it to fuse and form an anastomosis. The magnets then detach naturally, without any foreign material behind.

Unlike traditional methods such as stapling or suturing, the MagDI™ System avoids cutting or piercing the bowel tissue. It is designed to improve tissue alignment, promote healing, and support consistent, circumferential healing, without impeding the body’s natural healing process.

FDA approval was based on clinical data showing that the MagDI™ System successfully created patent side-to-side duodeno-ileal anastomosis in all trial participants, with no reports of bleeding, leakage, or obstruction.

This development represents a major shift in surgical practices, offering a new approach to minimally invasive surgery with zero incidents of bleeding or leaks. As a result, the use of stapling and suturing in bowel anastomosis may soon become outdated.


 

Source: https://www.prnewswire.com/news-releases/fda-clearance-issued-for-revolutionary-magnetic-compression-surgical-technique-soon-to-launch-in-us-market-302289053.html