Device Dossier
Archimedes Biodegradable Pancreaticobiliary Stent (BPS) - Fast - Polymeric biliary/pancreatic stent
Device Dossier for Archimedes Biodegradable Pancreaticobiliary Stent (BPS) - Fast - Polymeric biliary/pancreatic stent (Polymeric biliary/pancreatic…
- GMDN category: Polymeric biliary/pancreatic stent
- Sponsor: Endotherapeutics
Intended purpose
The Archimedes BPS is used to drain obstructed biliary or pancreatic ducts and is indicated for obstructed biliary and pancreatic ducts. The Archimedes BPS Fast degradation profile is intended to degrade over a period of 12 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 Fast degradation profile is 12 days. The process in which Archimedes BPS degrades is through hydrolysis.