Self-Forming Magnet (FLEX SFM)

The FLEX SFM is a magnetic compression anastomosis system used to create side-to-side connections (anastomoses) between the duodenum and ileum during minimally invasive laparoscopic surgery. Two magnet devices are delivered endoscopically and laparoscopically to compress tissue between them, causing necrosis and tissue healing that forms a patent anastomosis; the magnets naturally pass through the intestinal tract within 3-6 weeks. The device is intended for adult patients over 21 years old.

The FLEX SFM uses the same magnetic compression core technology as the predicate Mag DI device and targets the same anatomical location (duodenum and ileum). The proposed device has octagonal magnets with outer diameter 25 mm and 3 mm thickness, compared to the predicate's oval/rectangular 19.1 mm length magnets; the overall flat-to-flat dimension is 25.8 mm versus 19.1 mm. Both employ minimally invasive delivery instruments and biocompatible coatings (nickel, copper, gold, parylene); the mechanism of action—tissue hypoxia leading to necrosis and anastomosis formation—is equivalent.

ISO 10993 biocompatibility standards (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, pyrogenicity, subchronic toxicity/implantation, genotoxicity); ASTM D 4169:2022 transportation and shipping validation; ISO 11137-1:2006 and EN ISO 11137-1:2015 for e-beam radiation sterilization; ISO 10993-18 for chemical characterization. Performance testing included magnet clamping force, pressure, tensile strength, magnetic interference, and corrosion resistance.

The FLEX SFM is substantially equivalent because it shares the identical intended use (creation of duodeno-ileal anastomoses), the same technological principle (magnetic compression causing tissue necrosis), and equivalent biocompatible materials and coatings as the predicate Mag DI. Although the magnet dimensions differ slightly (octagonal vs. oval shape, 25.8 mm vs. 19.1 mm length), both dimensions are adequate to create appropriately sized anastomoses for enteral flow. Clinical data from 70 patients demonstrated 100% successful placement and patent anastomosis formation matching the predicate's performance (N=49, 100%), with comparable safety profiles and no device failures; non-clinical testing used identical or equivalent methods and acceptance criteria as the predicate.