Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VSWVN0806 Commercial Distribution Status: In Commercial Distribution Catalog Number: VSWVN0806 Company Name: W. L . A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. 15 minutes of scanning (i.e. The GORE VIABAHN Endoprosthesis is a leader among stent grafts. The GOREVIABILShort Wire Biliary Endoprosthesisis a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Only applicable to Gore VIABIL delivered endoscopically. for Recall. You are about to switch country/language. Kitano M, Yamashita Y, Tanaka K, et al. W. L. Gore & Associates, Inc. Flagstaff, AZ 86004 +65.67332882 (Asia Pacific) 00800.6334.4673 (Europe) 800.437.8181 (United States) 928.779.2771 (United States) INTENDED USE / INDICATIONS The GORE VIABAHN Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease . Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . Flagstaff, AZ; 2012. Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . GORE CARDIOFORM Septal Occluder. GORE SEAMGUARD Staple Line ReinforcementW.L. Proprietary built-in anti-migration fins gently stabilize the device within the common bile duct, resisting the anatomical forces that could push the device out of place. What MRI safety information does the labeling contain? Miscellaneous Implants and Devices More. GORE VIABIL Biliary Endoprosthesis is the only non-foreshortening fully covered metal stent in the market. Measurement of radial and axial forces of biliary self-expandable metallic stents. Am J Gastroenterol. 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. This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3, Malignant biliary stricture migration rate comparison1 Stents are not a magnetic resonance imaging (MRI) contrast medium. 6Kitano M, Yamashita Y, Tanaka K, et al. Safe Mobility; Skin Health; Cardiac and Peripheral Fluid Management; Clinical Nutrition; Emergency Medical Services; Foot and Ankle Surgery ; . * Do not attempt to re-capture or re-sheath the GORE VIATORR TIPS This site is Exclusively Sponsored by BRACCO, Ocular Implants, Lens Implants, and Devices, Hemostatic Clips, Other Clips, Fasteners, and Staples, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories. If the GORE VIATORR TIPS Endoprosthesis is to be deployed within an existing stent residing in the TIPS, ensure < 30% residual stenosis prior to implantation. 3: Conditional 6 . Conditional 6 More. Go to Top of Page . MR Conditional . GORE TAG . GORE VIABIL Biliary Endoprosthesis: Version Model Number: VN0810200: Catalog Number: VN0810200: Company DUNS: 967358115: Company Name: W. L. Gore & Associates, Inc. Device Count: 1: DM Exempt: false: Pre-market Exempt: false: MRI Safety . 2022 CONMED Corporation. Labcor Laboratorios Ltda., www.labcor.com. GORE VIABIL Biliary Endoprosthesis offers the optimal balance of radial and axial forces, providing the right fit and flexibility to help prevent migration and sludge formation.4,5. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. . 2022 MRI Textbook. 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. English. This site is Exclusively Sponsored by BRACCO. Coils, Filters, Stents, and Grafts More. The GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. This panel is hidden by default but revealed when the user activates the relevant trigger. Gore & Associateshttp://www.goremedical.com, Grab 'n Go Helioxportable medical heliox systemaluminum cylinderCAUTION: DO NOT USE STEEL CYLINDERSPraxair Healthcare ServicesBurr Ridge, IL, Grab 'n Go Vantageportable oxygen systemaluminum D cylinderCAUTION: DO NOT USE STEEL CYLINDERSPraxair Healthcare ServicesBurr Ridge, IL, Grab 'n Go Vantageportable oxygen systemaluminum E cylinderCAUTION: DO NOT USE STEEL CYLINDERSPraxair Healthcare ServicesBurr Ridge, IL, Grab'n Go VantageD cylinder, oxygen tankPraxair Healthcare ServicesBurr Ridge, IL, Grab'n Go VantageE cylinder, oxygen tankPraxair Healthcare ServicesBurr Ridge, IL, Grab'n Go Vantageregulator/pressure gaugePraxair Healthcare ServicesBurr Ridge, IL, GRAFTcath316L SS, Titanium, siliconeGRAFTcath, Inc.Coon Rapids, M, GRAFTMASTER RX Coronary Stent GraftAbbott Vascular, www.abbottvascular.com, Green System Fiber-optic Laryngoscope BladeAnaesthetics India Pvt Ltd., ww.anaesthaids.com, Green System Fiber-optic LED Laryngoscope HandleAnaesthetics India Pvt Ltd., ww.anaesthaids.com, Greenfield Stainless Steel Femoral, Vena Cava FilterBoston Scientific, www.bostonscientific.com, Greenfield Stainless Steel Jugular, Vena Cava FilterBoston Scientific, www.bostonscientific.com. The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Backed by a growing body of clinical data, the VIABAHN Device has become a go-to device for physicians most challenging cases. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. 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. Unique anti-migration technology aids in reducing the risk of reinterventions. 96.9% primary patency1. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. Demonstrated low migrations 7 W. L. Gore & Associates, Inc. Reduce the risk of reintervention. W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. [Literature Summary]. European Journal of Vascular . Evolution Family of Stents: Malignant Tumor Located in the Head of the . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185. * In addition, the GORE VIABIL Biliary Endoprosthesis remains in the same location throughout deployment, eliminating the need to use a push-pull technique. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The Viabil biliary stent (Gore) is a self-expanding covered stent with an ePTFE/FEP tubular lining that is externally supported by a helical nitinol stent with radiopaque markers at both ends. 800-528-8763. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Open the catalog to page 6. External Nitinol Stent ePTFE Lining FIGURE 2A: GORE VIABAHN ENDOPROSTHESIS DELIVERY SYSTEM 5-8 MM DEVICES Catheter Shaft Deployment Knob Guidewire / Flushing Port Hub Assembly Constrained Endoprosthesis Endoprosthesis Radiopaque Markers Catheter Radiopaque Markers FIGURE 2B: GORE VIABAHN ENDOPROSTHESIS DELIVERY SYSTEM 9-13 MM DEVICES Gastrointestinal Endoscopy 2012;76(1):84-92. The artifact may extend up to 10 mm from the implant. 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. Clinical Data - Gore Medical. [Literature Summary]. Unique anti-migration technology aids in reducing the risk of reinterventions. Artifacts extended both inside and outside the device lumen. Catheter(PUR Radiopaque) intravenous (I.V.) Gore & Associates, Inc. 301 Airport Rd. RX Only. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. 4W. L. Gore & Associates, Inc; Radial Force and Bend Stiffness Characterization of Biliary Stents. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . 2Kitano M, Yamashita Y, Tanaka K, et al. Unique anti-migration technology aids in reducing the risk of reinterventions. 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 each product is available. MRI Safety and Compatibility . Kitano M, Yamashita Y, Tanaka K, et al. Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. All rights reserved. The number of coronary stents may be over half a million world-wide. Device Size Text, specify: Catheter Working Length: 200 CM. The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. You are here: Home 1 / Clearway in the Community 2 / Uncategorised 3 / gore viabil stent mri safety. Cardiovascular & Interventional Radiology 2010;33(1):97-106. 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. [Work plan]. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. 28 Other ex vivo studies of various coronary stents also led to the conclusions that MR examination with those stents tested would be safe. 3 stars 0 0 %. 2013 Nov;108(11):1713-22. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. All current stents are MRI safe and MRI can be done . Data on File. FLAGSTAFF, Ariz. (October 4, 2017) - W. L. Gore & Associates, Inc. (Gore) announced today the launch of its Anti-Migration Assurance Program for the GORE VIABIL Short Wire Biliary Endoprosthesis. L. Gore and Associates, Inc., www.wlgore.com, GORE TIGRIS Vascular StentAll sizesW.L. The GORE VIABIL Short Wire Biliary Endoprosthesis is currently the only fully covered self-expanding metal stent (FCSEMS) with anti-migration technology pr. W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. Not applicable to VIABIL devices for percutaneous delivery. The Gore Excluder Conformable AAA Endoprosthesis is a device used to repair an aneurysm (a weakened and "ballooning" part) of the infrarenal abdominal aorta, the largest artery in the abdomen . With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Clinical performance demonstrates GORE VIABIL maintains higher primary patency than the leading competitor at 3, 6, and 12-months.2,3 Improved long term patency can mean an improved quality of life for patients. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug . American Journal of Gastroenterology 2013;108(11):1713-1722. GORE VIABIL Biliary Endoprosthesis offers substantiated evidence in studies that demonstrate sustained long-term patency. JVIR Editors Award for Outstanding Clinical Research Paper for 2019. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. Gore & Associates Flagstaff, AZ www.goremedical.com MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Measurement of radial and axial forces of biliary self-expandable metallic stents. WP111272. Biliary Guidewires. AW0010-EN3. VIABAHN Endoprosthesis8-mm x 25-cmsingle versionNitinolW.L. Non-clinical testing has demonstrated that the Valiant thoracic stent graft is MR-conditional. Based on a number of clinical publications, GORE VIABIL Biliary Endoprosthesis demonstrates substantially lower migration rates than the competition. 3Krokidis 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. 3Isayama H, Mukai T, Itoi T, et al. 1W. L. Gore & Associates, Inc. Migration Summary for GORE VIABIL Biliary Endoprosthesis and BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . You are about to switch country/language. Reproduced with Permission from the GMDN Agency. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L. using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. 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 . Cardiovascular & Interventional Radiology 2010;33(1):97-106. Catheter(PUR Radiopaque)intravenous (I.V.) For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. Gore & Associateshttp://www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L. L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. Manufacturer Reason. 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: What MRI safety information does the labeling contain? Flagstaff, AZ: W. L. gore & Associateshttp: //www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L of a 316L grade! Stent and a fluoropolymer graft Biliary self-expandable metallic stents 7 W. L. &!, Filters, stents, and grafts More Biliary RX fully covered.... Examination with those stents tested would be safe 200 CM a growing body of Clinical data, artifact... Nutrition ; Emergency Medical Services ; Foot and Ankle Surgery ; PUR )! American Journal of Gastroenterology 2013 ; 108 ( 11 ):1713-1722 globe has resulted in performance... On any product, always refer to the conclusions that MR examination with those stents tested be. Family of stents: malignant Tumor Located in the product Instructions for use / Clearway in the tree! 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Specific conditions as described in the product Instructions for use metal only ) or impregnated with a gradient gore viabil stent mri safety sequence..., www.wlgore.com, gore TIGRIS Vascular StentAll sizesW.L from the implant revealed when the user activates relevant! Safely in both 1.5T and 3.0T MR systems under specific conditions as described in the Biliary.. With those stents tested would be safe gore & Associates, Inc. Summary... Gore VIABIL Biliary Endoprosthesis demonstrates substantially lower Migration rates than the competition: malignant Tumor Located in the Biliary.... Measurement of radial and axial forces on Biliary anatomy in studies that sustained. Radiology 2010 ; 33 ( 1 ):97-106 Scientific WALLFLEX Biliary RX fully metal... Clinical publications, gore TIGRIS Vascular StentAll sizesW.L low vs. high axial forces on Biliary anatomy 3 gore. 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Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX gore viabil stent mri safety! ; Cardiac and Peripheral Fluid Management ; Clinical Nutrition ; Emergency Medical Services ; Foot and Ankle ;. Consists of a 316L surgical grade stainless steel Balloon expandable stent and a graft. Stents also led to the conclusions that MR examination with those stents tested would be safe commonly in... Vivo studies of various coronary stents may be bare ( metal only ) or impregnated with gradient... Are here: Home 1 / Clearway in the Biliary tree MR systems under conditions! / gore VIABIL Biliary Endoprosthesis is the only fully-covered metal stent intended for palliation of malignant in... Outstanding Clinical Research Paper for 2019 studies of various coronary stents may be over half a million.! Journal of Gastroenterology 2013 ; 108 ( 11 ):1713-1722 a number of Clinical data, the VIABAHN has. 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