Device typePolymer-metal oesophageal stent: A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.
FDA categoryProsthesis, Esophageal
Device ID08806367084125
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Stent Diameter18 Millimeter
Stent Length110 Millimeter
Size1800 mm Delivery system