Self-Forming Magnet (Flexagon)

The Flexagon System is a magnetic compression anastomosis device used to create side-to-side duodeno-ileal anastomoses in minimally invasive laparoscopic surgery. Two magnetic implants are positioned to attract each other, creating clamping pressure that causes tissue hypoxia and necrosis between them. Once the anastomosis (surgical connection) heals, the magnets naturally pass through the intestinal tract within 3-6 weeks.

The Flexagon has the same core technology as the predicate FLEX SFM: neodymium-iron-boron magnets electroplated with nickel and copper, stainless steel, Nitinol components, and Parylene C coating. Dimensional specifications are nearly identical (outer diameter 25mm, inner 18mm, 3mm thickness). Both achieve minimum clamping force ≥0.38 lbf at 4mm and ≥10 PSI at 1mm. Minor material differences include Flexagon's use of Ultra-High Molecular Weight Polyethylene suture versus the predicate's Polybutester suture, and Flexagon lacks the predicate's gold plating.

ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, acute/subchronic toxicity, genotoxicity); ISO 11137-1:2006 (E-beam radiation sterilization); ASTM D 4169:2022 (shipping/transportation validation); GLP porcine survival studies; cadaver testing; and design verification testing for magnet clamping force, pressure, magnetic interference, and corrosion resistance.

The Flexagon demonstrates substantial equivalence through identical intended use (duodeno-ileal anastomosis), matching technological characteristics and mechanism of action (magnetic compression), equivalent performance specifications (clamping force and pressure), and passing identical biocompatibility and sterility testing. Clinical data from overseas trials showed 100% successful magnet placement with alignment and patent anastomosis formation at day 30, with safety comparable to the predicate. Animal studies demonstrated the device performs as well as or better than standard stapled anastomoses, meeting all predefined effectiveness and safety criteria like the predicate device.