ARCHIMEDES Biodegradable Pancreatic Stent

The ARCHIMEDES Biodegradable Pancreatic Stent is a single-use, sterile stent designed to drain pancreatic ducts in patients requiring pancreatic duct stenting. The device is delivered endoscopically through the working channel of a therapeutic endoscope using a guidewire and pushing catheter, and it biodegrades in the patient's body within 95 days rather than requiring surgical removal.

The ARCHIMEDES stent features a fluted cross-sectional profile with three drainage channels (two spiral helical channels and one hollow inner lumen), a curved design to fit natural pancreatic duct anatomy, and flap/split-end features to prevent migration. The primary technological difference from the predicate is that ARCHIMEDES is made of a bioresorbable polymer that degrades in vivo, whereas the Advanix predicate device is non-biodegradable plastic requiring removal. Both are offered in multiple French sizes (6F, 8F, 10F) and various lengths (40–225 mm).

ISO 10993-1:2009 (Biological Evaluation of Medical Devices — Part 1); ISO 11135-1 (Sterilization by Ethylene Oxide); ISO 10993-7 (Ethylene Oxide Sterilization Residuals). Biocompatibility testing included MEM Elution Cytotoxicity, Implantation, Guinea Pig Maximization Sensitization, 28-day IV/IP Systemic Toxicity, and Material Mediated Pyrogen studies.

ARCHIMEDES is substantially equivalent to the Advanix predicate because both devices share the same intended use (pancreatic duct drainage), same delivery method, same regulatory classification (Class II, 21 CFR 876.5010), and comparable technological characteristics (dimensions, delivery system compatibility, deployment approach). Although ARCHIMEDES uses a biodegradable polymer instead of non-biodegradable plastic, this material difference does not raise new safety or effectiveness questions because the stent operates identically to existing non-biodegradable pancreatic stents whose risks are well-understood and mitigated through existing general and special controls. All bench and biocompatibility testing met acceptance criteria, and eight clinical studies demonstrated safety and efficacy.