Meet the challenges of portal hypertension

Image of older patient on hospital bed talking with a young child

For patients with portal hypertension, including those with variceal bleeding and refractory ascites, the GORE® VIATORR® TIPS Endoprosthesis has been improving patient outcomes for more than 20 years. The VIATORR® Device has proven patency1 and patients treated with the VIATORR® Device have a higher one-year survival than those treated with non-TIPS therapy.2-4

Purpose-built for TIPS

  • Controlled expansion sleeve is designed to provide intraoperative adjustability of the diameter between 8 mm and 10 mm.*
    • Designed to reach a targeted portal pressure gradient to meet the specific needs of the patient.
    • Lasting diameter control. Size and set the diameter to stay.*
  • Bile-resistant, ePTFE lining designed to sustain patency due to reduced in-stent stenosis.
  • Uncovered portion for sustained portal vein and shunt perfusion.
  • Optimized radial force and flexibility engineered for conformability in tortuous anatomy.

Covered stent grafts offer long-term patency, compared to bare metal stents

Bar graph showing primary patency of the VIATORR® Device compared to non-covered stent grafts

Studies reveal that, at the time of TIPS creation, ePTFE-covered stent grafts have shown improved patency, ascites control and rebleeding prevention, compared to bare metal stents.5-13

For patients undergoing TIPS placement, the Advancing Liver Therapeutic Approaches (ALTA) group recommends, "The use of an ePTFE-lined stent graft with controlled expansion, which allows the operator to tailor the amount of portosystemic shunting based on the indication, target gradient and patient comorbidities."2

Variceal bleeding outcomes

Early TIPS compared to drug therapy plus endoscopic band litigation (EBL) for variceal bleeding13

Red Circle indicating 86%

1-year survival following early TIPS procedure with the VIATORR® Device, compared to 61% 1-year survival following pharmacotherapy plus endoscopic band litigation (P < 0.001)†,13

Red Circle indicating 97%

1-year control of bleeding following early TIPS procedure with the VIATORR® Device, compared to 50% 1-year survival following pharmacotherapy plus endoscopic band litigation (P < 0.001)‡,13

Red Circle with a line indicating no increase

No increase in the risk of hepatic encephalopathy (28%), compared to 1-year hepatic encephalopathy (40%) following pharmacotherapy plus endoscopic band litigation (P = 0.13)13

Refractory ascites outcomes

Early TIPS compared to large volume paracenteses (LVP) and albumin for refractory ascites14

Red hollow checkmark

Improved survival. TIPS with the VIATORR® Device demonstrated higher transplant-free survival (93%), compared to large volume paracenteses (LVP) and albumin infusion (52%) (P = .003)12

Text reads: 1 vs. 10

Number of paracenteses required to treat ascites following placement of the VIATORR® Device, compared to paracentesis treatment alone12

Red circle with a line indicating no increase

No increase in the risk of hepatic encephalopathy (35%), compared to 1-year hepatic encephalopathy (35%) following to large volume paracenteses (LVP) and albumin infusion (P = .868)12

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* Based on benchtop data on file. Less than 0.25 mm increase in diameter (diameter expansion) demonstrated by a simulated 10-year period at physiologic portal pressures.

† For a combined group of patients with Child-Pugh C (CP-C) score ≤13 or Child-Pugh B with active bleeding (CP-B + AB) at diagnostic endoscopy.

‡ One-year actuarial probability of remaining free of failure to control bleeding and of variceal rebleeding.

References

  1. Bureau C, Pagan JCG, Layrargues GP, et al. Patency of stents covered with polytetrafluoroethylene in patients treated by transjugular intrahepatic portosystemic shunts: long term results of a randomized multicentre study. Liver International 2007;27(6):742-747.
  2. Boike JR, Thornburg BG, Asrani SK, et al. North American Practice-Based Recommendations for Transjugular Intrahepatic Portosystemic Shunts in Portal Hypertension. Clinical Gastroenterology and Hepatology. 2022;20(8):1636-1662.e36.
  3. Bureau C, Thabut D, Oberti F, 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.
  4. García-Pagán JC, Caca K, Bureau C, et al. Early use of TIPS in patients with cirrhosis and variceal bleeding. The New England Journal of Medicine 2010;362(25):2370-2379. 
  5. Angeloni S, Merli M, Salvatori FM, et al. Polytetrafluoroethylene covered stent grafts for TIPS procedure: 1-year patency and clinical results. The American Journal of Gastroenterology 2004;99:280-285.
  6. Barrio J, Ripoll C, Bañares R, et al. Comparison of transjugular intrahepatic portosystemic shunt dysfunction in PTFE-covered stent-grafts versus bare stents. European Journal of Radiology 2005;55:120-124.
  7. Charon JP, Alaeddin FH, Pimpalwar SA, et al. Results of a retrospective multicenter trial of the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation. Journal of Vascular & Interventional Radiology 2004;15:1219-1230.
  8. Hausegger KA, Karnel F, Georgieva B, et al. Transjugular intrahepatic portosystemic shunt creation with the Viatorr expanded polytetrafluoroethylene-covered stent-graft. Journal of Vascular & Interventional Radiology 2004;15:239-248.
  9. Otal P, Smayra T, Bureau C, et al. Preliminary results of a new expanded-polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt procedures. American Journal of Roentgenology 2002;178:141-147.
  10. Perarnau JM, Le Gouge A, Nicolas C, et al. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial. Journal of Hepatology 2014;60:962-968.
  11. Riggio O, Ridola L, Angeloni S, et al. Clinical efficacy of transjugular intrahepatic portosystemic shunt created with covered stents with different diameters: results of a randomized controlled trial. Journal of Hepatology 2010;53:267-272.
  12. Tripathi D, Ferguson J, Barkell H, et al. Improved clinical outcome with transjugular intrahepatic portosystemic stent-shunt utilizing polytetrafluoroethylene-covered stents. European Journal of Gastroenterology & Hepatology 2006;18:225-232.
  13. Maleux G, Perez-Gutierrez NA, Evrard S, et al. Covered stents are better than uncovered stents for transjugular intrahepatic portosystemic shunts in cirrhotic patients with refractory ascites: a retrospective cohort study. Acta Gastro-Enterologica Belgica 2010;73(3):336-341.

eIFU Symbol

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.

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