Device Dossier
ELLA-BD Stent Biliary THP - Polymer-metal biliary stent, bioabsorbable
Device Dossier for ELLA-BD Stent Biliary THP - Polymer-metal biliary stent, bioabsorbable (Polymer-metal biliary stent, bioabsorbable, Class III, sponsor…
- GMDN category: Polymer-metal biliary stent, bioabsorbable
- Sponsor: Endotherapeutics
Intended purpose
The ELLA-BD Stent Biliary THP is intended for the treatment of benign bile duct strictures.
Functional description
A self-expanding biodegradable biliary stent supplied with a single-use delivery system. The stent is intended to treat benign biliary strictures by means of mechanical force to maintain lumen patency. The stent is intended to fully degrade in the human body over a period of 3 to 6 months.