510(k) for Cordis Endovascular's biliary stent:
This article was originally published in Clinica
Executive Summary
The US FDA has cleared Cordis Endovascular's PALMAZ CORINTHIAN transhepatic biliary stent and delivery system. The balloon-expandable stent is designed to relieve symptoms caused by malignant neoplasms of the biliary tree. These cancers cause bile to flow back into the systemic blood circulation which leads to jaundice and changes in liver functions. The stent restores and maintains bile flow by re-opening the obstructed bile duct.