Device Dossier

Archimedes Biodegradable Pancreaticobiliary Stent (BPS) - Medium - Polymeric biliary/pancreatic stent

Device Dossier for Archimedes Biodegradable Pancreaticobiliary Stent (BPS) - Medium - Polymeric biliary/pancreatic stent (Polymeric biliary/pancreatic…

Intended purpose

The Archimedes BPS is used to drain obstructed biliary or pancreatic ducts and is indicated for obstructed biliary or pancreatic ducts. The Archimedes BPS Medium degradation profile is intended to degrade over a period of approximately 20 days.

Functional description

Polymeric stent with a fluted, cross-sectional profile and containing two channels which spiral in a double helix down the length of the stent. The Archimedes BPS is designed to fit the natural curvature of the common bile duct and pancreatic duct. The ends of the Archimedes BPS are tapered to allow insertion through the papilla. The minimal strength retention time for the Archimedes BPS Medium degradation profile is 20 days. The process in which Archimedes BPS degrades is through hydrolysis.

TGA Public Summary