TIPS devices
GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
by W. L. Gore & Associates, Inc.
A device intended to be permanently implanted to create or revise a transjugular intrahepatic portosystemic shunt (TIPS), a bypass for blood made between the portal and hepatic veins of the liver delivered to the liver via percutaneous access from the jugular vein, to treat portal hypertension and its complications (e.g., bleeding varices, gastropathy, ascites, and/or hepatic hydrothorax). It is a stent-like tube typically made of metal and polymer materials [e.g., nickel-titanium alloy (Nitinol), expanded polytetrafluoroethylene (ePTFE)] that expand upon implantation. It is implanted using a catheter delivery system and is available in various diameters (e.g., 8 - 12 mm).
GORE VIATORR TIPS Endoprosthesis with Controlled Expansion models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| PTB6104275 | Catheter Gauge 10 Fr; Length 4 cm; Length 2 cm | MR Conditional | Available |
| PTB6105275 | Catheter Gauge 10 Fr; Length 5 cm; Length 2 cm | MR Conditional | Available |
| PTB6106275 | Catheter Gauge 10 Fr; Length 6 cm; Length 2 cm | MR Conditional | Available |
| PTB6107275 | Catheter Gauge 10 Fr; Length 7 cm; Length 2 cm | MR Conditional | Available |
| PTB6108275 | Catheter Gauge 10 Fr; Length 8 cm; Length 2 cm | MR Conditional | Available |
FDA clearances
- PMA P040027 July 2020
Procedures that use tips devices
Frequently asked questions
What is GORE VIATORR TIPS Endoprosthesis with Controlled Expansion used for?
A device intended to be permanently implanted to create or revise a transjugular intrahepatic portosystemic shunt (TIPS), a bypass for blood made between the portal and hepatic veins of the liver delivered to the liver via percutaneous access from the jugular vein, to treat portal hypertension and its complications (e.g., bleeding varices, gastropathy, ascites, and/or hepatic hydrothorax). It is a stent-like tube typically made of metal and polymer materials [e.g., nickel-titanium alloy (Nitinol), expanded polytetrafluoroethylene (ePTFE)] that expand upon implantation. It is implanted using a catheter delivery system and is available in various diameters (e.g., 8 - 12 mm).
Who makes GORE VIATORR TIPS Endoprosthesis with Controlled Expansion?
GORE VIATORR TIPS Endoprosthesis with Controlled Expansion is made by W. L. Gore & Associates, Inc.. It is listed under tips stent grafts and access sets in our device library.
What sizes does GORE VIATORR TIPS Endoprosthesis with Controlled Expansion come in?
Sizes listed for GORE VIATORR TIPS Endoprosthesis with Controlled Expansion: Length: 2–8 cm; Catheter Gauge: 10 Fr. Confirm availability with the manufacturer's instructions for use.
Is GORE VIATORR TIPS Endoprosthesis with Controlled Expansion MRI safe?
The FDA device database lists GORE VIATORR TIPS Endoprosthesis with Controlled Expansion as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is GORE VIATORR TIPS Endoprosthesis with Controlled Expansion FDA cleared?
GORE VIATORR TIPS Endoprosthesis with Controlled Expansion is covered by FDA submission P040027.
How do I contact a W. L. Gore & Associates, Inc. sales representative?
W. L. Gore & Associates, Inc. has not listed representatives on LA Vascular yet. Visit the W. L. Gore & Associates, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.