FDAnews Device Daily Bulletin

FDA ISSUES CONSUMER INFORMATION ON NEWLY APPROVED STENT

May 5, 2006
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The FDA has posted consumer information on Gore Medical Products' Gore VIATORR Tips endoprosthesis, an implantable stent that "will allow blood to flow more easily through the liver."

The device is used to treat increased blood pressure, or portal hypertension, caused by decreased blood flow to the liver. This decreased blood flow can also lead to complications including bleeding veins (variceal bleeding), fluid in the chest cavity (refractory ascites), stomach disease (gastropathy) and fluid in tissue lining the chest cavity (hepatic hydrothorax), the agency said.

The procedure is meant to decrease the frequency of alternative treatments for the condition, and is typically done by a radiologist. The stent is implanted through a catheter inserted into the jugular vein on the right side of the neck.

There are no known contraindications to using this device, the agency said.