The self-expanding GORE VIABIL Short Wire Biliary Endoprosthesis is the only fully-covered metal stent with anti-migration technology proven to minimize the risk of reintervention. Kitano M, Yamashita Y, Tanaka K, et al. Biliary Guidewires. For a full version of conditions, please see product Instructions for Use (IFU). What MRI safety information does the labeling contain? It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. The VIABAHN Device is aleader among stent grafts. You are about to switch country/language. Gore's Anti-Migration Assurance Program offered through ConMed. * Do not attempt to re-capture or re-sheath the GORE VIATORR TIPS 2013 Nov;108(11):1713-22. GORE VIABIL Short Wire Biliary Endoprosthesis Catalogue Number Nominal Endoprosthesis Diameter (mm) Length (cm) Working Lengths of Delivery Catheter (cm) Drainage Holes Located at the Hilar Region Transmural Drainage Holes Length (cm) VH0806200: VSWVH0806: 8 6: 200: Holes: 2: VH0808200: VSWVH0808: 8 8: 200: Holes: 2: VH0810200: Unique anti-migration technology aids in reducing the risk of reinterventions. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. 5Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A. Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. Optimal Conformability Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. The information on this page is current as of November 2022. Warning: The safety and effectiveness of this device for use in the vascular system have not been established. This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3, Malignant biliary stricture migration rate comparison1 When the GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface was placed within a bare nitinol stent the image artifact extended up to 20 mm from the devices. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. The GOREVIABILShort Wire Biliary Endoprosthesisis a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. The artifact may extend up to 10 mm from the implant. Advanix Biliary Stents; United Kingdom. Unique anti-migration technology aids in reducing the risk of reinterventions. This site is Exclusively Sponsored by BRACCO, Cardiovascular Catheters, Other Catheters, and Accessories, Cardiac Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Monitors, Ocular Implants, Lens Implants, and Devices. Cardiovascular & Interventional Radiology 2011;34(2):352-361. For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. Gore Viabil Stent with Holes, 10 mm x 8 cm: 1 EA: Stock Allocated QTY: / Remaining QTY: / Allocation Reset Date: CNDVH1010200: GORE, BILIARY, ENDOPROSTHESIS, 10MM X 100MM: Artifacts extended both inside and outside the device lumen. GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short Wire Biliary Endoprosthesis. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. The product you are looking for does not exist for the target country/language. 15 minutes of scanning (i.e. Backed by a growing body of clinical data, the VIABAHN Device has become a go-to device for physicians most challenging cases. MPD Customer Care. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . for Recall. Low Axial Force: GORE VIABIL Biliary . Manufacturer Reason. Measurement of radial and axial forces of biliary self-expandable metallic stents. L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. Catheter(PUR Radiopaque)intravenous (I.V.) It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. This means the implant will not appreciably foreshorten when deployed. This outperforms BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent migration rates, which ranged 013%.1. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. JVIR Editors Award for Outstanding Clinical Research Paper for 2019. All rights reserved. It can be scanned safely in both 1.5T and 3.0T MR systems under specific conditions as described in the product Instructions for Use. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . Refer to the . Unique anti-migration technology aids in reducing the risk of reinterventions. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. In 1 study, ex vivo testing at 1.5 T on 19 different coronary stents revealed 2 to be nonferromagnetic and the remaining 17 to be at worst "minimally" ferromagnetic. The GORE VIABIL Biliary Endoprosthesis offers the optimal balance of low Axial force (Af) and moderate Radial force (Rf), allowing natural conformance of the stent to the bile duct anatomy while maintaining industry-leading primary patency rates. 29-32 Studies of peripherally . * In addition, the GORE VIABIL Biliary Endoprosthesis remains in the same location throughout deployment, eliminating the need to use a push-pull technique. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VH1008040 Commercial . L. Gore and Associates, Inc., www.wlgore.com, GORE TIGRIS Vascular StentAll sizesW.L. Cardiovascular & Interventional Radiology 2010;33(1):97-106. With a 0.2% average reported migration rate, were so confident in these outcomes that we will replace it if a migration occurs.6,7. WP103837. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, Viadurleoprolide acetate implantBayer Healtcare PharmaceuticalsWest Haven, CT, Viadurleuprolide acetate implantTitaniumBayer HealthCare PharmaceuticalsWest Haven, CT, VIATORR EndoprosthesisStentNitinolW.L. What MRI safety information does the labeling contain? A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. 3: Conditional 6 . Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. Safe More. For Additional Information Contact. FLAGSTAFF, Ariz. (August 1, 2017) - 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 . All current stents are MRI safe and MRI can be done . Subjects with stent removal data available . Measurement of radial and axial forces of biliary self-expandable metallic stents. Based on clinical publications, the GORE VIABIL Biliary Endoprosthesis maintains higher primary patency than the leading competitor at 3, 6 and 12 months post-deployment, when implanted to manage malignant biliary strictures.5,6 The moderate radial force, low axial force and durable, nonporous ePTFE/FEP liner of GORE VIABIL Biliary Endoprosthesis are designed to enhance patency. (Reported data is aggregated from 47 studies reported between 2002 and 2018), Significantly Lower Migration Rates than the Market Leaders1. 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Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . 4 W/kg (first level controlled operating mode), 15 minutes of scanning (i.e., per pulse sequence), In non-clinical testing, the image artifact caused by the GORE, In non-clinical testing, the image artifact caused by the device extends approximately 5 mm from the GORE, Immediately after placement if conditions are met, 10 mm relative to the size and shape of the vascular device, 60 minutes of continuous RF (a sequence or back to back series/scan without breaks).