GT Metabolic Wins De Novo Nod for Magnet Compression Anastomosis Tech

GT Metabolic Solutions has been granted U.S. Food and Drug Administration (FDA) de novo clearance for its first-generation MagDI system for side-to-side duodeno-ileal anastomosis.
 
Traditional staples or sutures for anastomosis can be challenging to use in confined spaces during minimally invasive procedures and can cause trauma by cutting or piercing bowel tissue and leaving foreign material behind. Magnetic compression anastomosis was designed to remove the need for bowel incision, reduce technical variability, and be naturally excreted from the body.
 
The company said seven peer-reviewed publications have been completed to date, with the most recent being a multi-center clinical trial consisting of 42 patients which showed no anastomotic leaks, bleeds, or obstruction in duodeno-ileal side-to-side anastomosis in bariatric and metabolic procedures.
 
GT Metabolic believes future planned studies could broaden patient outcome improvements and possible reach more patients with the less invasive anastomotic approach.
 
“Creating a secure anastomosis free of complications bleeds or leaks is the goal of any minimally invasive surgical approach,” said Michel Gagner, MD, 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.”
 
“Obtaining Medical Device De Novo Classification to market our platform in just four years following the company’s inception is incredible,” added Thierry Thaure, CEO and co-founder of GT Metabolic. “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.”