Product Value Summary
GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
Provides clinical and economic value for treating patients with refractory ascites and variceal bleeding
GORE® VIATORR® Device maintains significantly increased patency compared to bare metal stent alternatives. It is effective in lowering portal pressure gradients in patients with refractory ascites and variceal bleeding.*
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* Data on file with Gore PMA P040027.
1. Bureau C, Thabut D, Oberti D, et al. Transjugular intrahepatic portosystemic shunts with covered stents increase transplant-free survival of patients with cirrhosis and recurrent ascites. Gastroenterology 2017;152(1):157-163.
http://www.sciencedirect.com/science/article/pii/S0016508516351101.
2. Premier Applied Sciences®, Premier, Inc. Premier Healthcare Database: Data that Informs and Performs. Charlotte, NC: Premier, Inc; 2018. [White paper].
https://learn.premierinc.com/white-papers/premier-healthcare-database-whitepaper.
3. García-Pagán JC, Caca K, Bureau K, et al; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. New England Journal of Medicine 2010;362(25):2370-2379. https://www.nejm.org/doi/full/10.1056/NEJMoa0910102.
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
INTENDED USE/INDICATIONS FOR USE: The GORE® VIATORR® TIPS Endoprosthesis is indicated for use in the de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, refractory ascites and/or hepatic hydrothorax.
CONTRAINDICATIONS: There are no known contraindications for this device.