This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name:GORE VIATORR® TIPS Endoprosthesis
Manufacturer : W.L. Gore & Associates, Inc.
Address : 3450 West Kiltie Lane, Flagstaff, Arizona 86001
Approval Date : December 6, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040027a.pdf
What is it? The GORE VIATORR TIPS Endoprosthesis is a tube (stent) that is permanently implanted in the liver using a catheter delivery system inserted into a large vein in the neck. The stent is a flexible metal mesh tube with a white material lining most of the inner surface. The implanted stent will allow blood to flow more easily through the liver.
When is it used? A doctor may use this device to treat increased blood pressure in the portal vein (portal hypertension) caused by decreased blood flow through the liver and its complications such as:
- a bleeding vein (variceal bleeding),
- fluid in the chest cavity (refractory ascites),
- stomach disease (gastropathy), and
- fluid in tissue lining the chest cavity (hepatic hydrothorax).
How does it work? The procedure is typically performed by a radiologist. Many patients receive a local anesthesia to numb a small area of the skin plus sedative and pain medications. In certain cases, general anesthesia may be used, where the patient goes to sleep.
A needle is initially placed in the jugular vein in the right side of the neck to make a small hole. Needles and long, thin tubes called catheters can then be advanced down to the veins in the liver.
A needle is inserted to make a connection between an adjacent vein and a branch of the portal vein. This channel is then expanded, and a tube called a stent is inserted to allow blood to flow more easily through the liver. The stent is left in place.
What will it accomplish? The increased blood flow through the liver should reduce the portal hypertension, so that alternative treatments for the complications of portal hypertension may not be needed as often.
When should it not be used? There are no known contraindications to using this device.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040027