Gore touts reduced portal hypertension, complications in Viatorr Tips trial

W.L. Gore & Associates today released preliminary data from a trial of its Viatorr Tips endoprosthesis with controlled expansion, touting reduced portal hypertension treatment complications when compared to the company’s legacy Tips device and bare metal stents.

Data from the study was presented at The International Liver Congress 2017 in Amsterdam, the Flagstaff, Ariz.-based company said.

Preliminary data from the trial, which has 21 patients currently and is still enrolling, also indicated a reduction in hospital admissions from cirrhosis-related complications, including refractory ascites and sepsis, when the Viatorr Tips with CE was compared to bare metal stents.

The Viatorr Tips endoprosthesis is a transjugular intrahepatic portosystemic shunt designed to create a new connection and reroute blood flow to reduce differences in pressure in the vein that connects digestive organs to the liver, and keep that new connection open.

Researchers at Germany’s University of Bonn compared data from the 21 enrolled patients and retrospective data from 48 patients with the Gore Viatorr Tips endoprosthesis and 36 patients with a bare metal stent.

At 3 months, the group with the Viatorr Tips with CE showed higher blood flow velocity and lowered MELD-Na scores, while both Viatorr groups showed reduced early splanchnic vein thrombosis compared to the bare metal stent group. Both Viatorr groups also reported fewer readmissions from sepsis, Gore said.

Patients with the Viatorr Tips with CE had fewer readmissions from ascites as well, though this was only demonstrated after 3 months, which researchers suggest could be due to the diameter control of the CE-equipped Viatorr Tips device.

“The goal in Tips creation is to shunt as much blood as necessary to reduce portal pressure below the threshold that leads to portal hypertension complications, and as little blood as possible to maintain hepatic perfusion and cardiac output. But when a stent is underdilated (less than the device’s nominal diameter), a common technique in pursuing the ideal gradient, the device diameter may increase over time reaching the nominal diameter in as little as six weeks. Since liver stiffness varies, the amount and rate of this passive expansion is unpredictable. As a result, the change in pressure, increase in shunting and increase in hyperdynamic circulation, factors that could potentially induce serious complications, are also unpredictable. The new capabilities of the Gore Viatorr Tips endoprosthesis with controlled expansion allow us to optimize the shunt diameter (at time of implantation) to achieve and maintain the desired portal pressure. The preliminary data show this forward-thinking attribute may result in direct patient benefits including reduced readmissions and complications such as hepatic encephalopathy,” Dr. Jonel Trebicka of Germany’s University of Bonn said in a prepared statement.

Gore’s Viatorr Tips endosprosthesis with CE has FDA approval in the US and CE Mark approval in the European Union for treating portal hypertension with Tips procedures, the company said.

“The patency and performance data on our fixed-diameter Gore Viatorr Tips Endoprosthesis is unmatched, but we understood the potential challenges of passive expansion if the stent is underdilated. We’re excited to see the preliminary results of this study which suggest that improved diameter control may reduce complications and resulting readmissions. We look forward to the long term results of the ongoing study at the University of Bonn,” Gore vascular biz lead Eric Zacharias said in a press release.

Last month, Gore said its Tag conformable thoracic stent graft was used in its 1st commercial procedure after the system won CE Mark approval in the European Union last month.

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