FLAGSTAFF, Ariz.--(BUSINESS WIRE)--The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion, a new
device configuration developed by W. L. Gore & Associates, Inc. (Gore),
may further reduce portal hypertension treatment complications, even
compared to the GORE®
VIATORR® TIPS Endoprosthesis, Gore’s legacy TIPS device, which has a
strong history of patency and proven performance at fixed diameters.
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These findings were obtained from the abstract presented at The
International Liver Congress 2017 in Amsterdam1. The
preliminary data at three months also confirmed that hospital
readmissions from cirrhosis-related complications, including refractory
ascites and sepsis, were significantly reduced using either of the GORE
VIATORR TIPS Endoprosthesis products compared to bare metal stents.
Portal hypertension is an increase in the pressure in the vein that
connects the digestive organs to the liver and is most often caused by
cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS)
procedures create a new connection to reroute blood flow and reduce the
difference in pressure, or pressure gradient, across the liver; a device
such as the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
keeps the new connection open.
“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,” said Prof. Jonel Trebicka, MD,
PhD, Department of Internal Medicine, University of Bonn, Germany. “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.”
The physician-sponsored, case-control study is ongoing at the University
of Bonn in Germany and continues to enroll patients in the Controlled
Expansion arm. Preliminary findings were based on 21 patients receiving
the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion, and
retrospective data of 48 patients receiving the GORE VIATORR TIPS
Endoprosthesis and 36 patients receiving a bare metal stent. At three
months, the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
group showed significant superiority compared to both other groups in
several areas including lower MELD-Na score (p = 0.019) and higher blood
flow velocity (p = 0.002). Both the GORE VIATORR TIPS Endoprosthesis
with Controlled Expansion group and the GORE VIATORR TIPS Endoprosthesis
group experienced reduced early splanchnic vein thrombosis (p < 0.001)
compared to the bare metal stent group. Both the GORE VIATORR TIPS
Endoprosthesis with Controlled Expansion group and GORE VIATORR TIPS
Endoprosthesis group experienced fewer readmissions from sepsis (p =
0.034). The GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
group experienced fewer readmissions from ascites (p = 0.006).
Importantly, this beneficial effect was only observed after three months
of implantation, suggesting that the lasting diameter control of
Controlled Expansion may be at least partly responsible for the
reduction in this post-TIPS complication. The study authors suggest that
this underlines the importance of stent diameter control in the
performing of TIPS. Further studies are necessary to confirm the
benefits of lasting diameter control.
“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,” said Eric
Zacharias, Gore Medical Vascular Business Leader. “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.”
The GORE VIATORR TIPS Endoprosthesis with Controlled Expansion provides
physicians novel diameter control capabilities to reach a targeted
portal pressure gradient during implantation and set the diameter to
stay. The addition of controlled expansion capabilities builds on the
legacy of proven patency in de novo and revision TIPS procedures
of the GORE VIATORR TIPS Endoprosthesis. The GORE VIATORR TIPS
Endoprosthesis with Controlled Expansion features the same proprietary
ePTFE graft lining that minimizes transmural permeation of bile and
mucin (common causes of patency loss). With the new controlled expansion
capability, physicians can start at the smallest diameter (8 mm) and
balloon up as needed during implantation to optimize the diameter until
the target pressure gradient is reached. Benchtop data on file showed
diameter expansion was no more than 0.25 mm over a simulated 10-year
period at physiological portal pressures. Further, the new device now
covers a range of diameters between 8 and 10 mm in a single device,
helping to simplify inventory.
The GORE VIATORR TIPS Endoprosthesis with Controlled Expansion is FDA
approved and CE Marked for the treatment of portal hypertension with
TIPS procedures. To request a reprint of the abstract presented, please
To learn more about the approval and launch of this device, please
For additional product information, please visit: http://www.goremedical.com/products/viatorr---controlled-expansion.
1. Praktiknjo M, Lehmann J, Fischer S, Strassburg CP, Meyer C, Trebicka
J. Novel diameter controlled expansion TIPS (Viatorr CX®) graft reduces
readmission compared to regular covered TIPS graft and bare metal graft.
Presented at The International Liver Congress (ILC); April 19-23, 2017;
Amsterdam, The Netherlands. Journal of Hepatology
2017;66(Supplement):S48-S49. PS-084.
MEDICAL PRODUCTS DIVISION
Gore Medical Products Division engineers devices that treat a range of
cardiovascular and other health conditions. With more than 40 million
medical devices implanted over the course of more than 40 years, Gore
builds on its legacy of improving patient outcomes through research,
education and quality initiatives. Product performance, ease of use and
quality of service provide sustainable cost savings for physicians,
hospitals and insurers. Gore is joined in service with clinicians and
through this collaboration we are improving lives. www.goremedical.com
ABOUT W. L. GORE & ASSOCIATES
W. L. Gore & Associates is a global materials science company dedicated
to transforming industries and improving lives. Founded in 1958, Gore
has built a reputation for solving complex technical challenges in the
most demanding environments — from revolutionizing the outerwear
industry with GORE-TEX® fabric to creating medical devices that improve
and save lives to enabling new levels of performance in the aerospace,
pharmaceutical and mobile electronics markets, among other industries.
The company is also known for its strong, team-oriented culture and
continued recognition from the Great Place to Work® Institute.
Headquartered in Newark, Del., Gore employs approximately 10,000
Associates and generates annual revenues that exceed $3 billion. www.gore.com
Products listed may not be available in all markets.
GORE®,
GORE-TEX®, and VIATORR® are trademarks of W. L. Gore & Associates
Contacts
Bliss Integrated Communication for Gore Medical
Claire LaCagnina,
212-840-8079
or
Liz
DeForest, 212-584-5477