Safe More. American Journal of Gastroenterology 2013;108(11):1713-1722. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VH1008040 Commercial . VIABAHN Endoprosthesis8-mm x 25-cmsingle versionNitinolW.L. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug . Vivendi Bovine Pericardium Patch with L-Hydro. Catheter(PUR Radiopaque) intravenous (I.V.) Open the catalog to page 6. This self-expanding biliary stent provides the control and ease of use physicians demand and the outcomes they count on to deliver palliative care to their high risk cases, supported through proven results: * If deployed as instructed, the endoprosthesis will not appreciably foreshorten. * In addition, the GORE VIABIL Biliary Endoprosthesis remains in the same location throughout deployment, eliminating the need to use a push-pull technique. The only fully covered metal stent with anti-migration technology. RX Only. Were here to help! As we cannot control the content, data security, or privacy practices of any third-party website, we encourage you to read the policies of every website you visit. Clinical Data - Gore Medical. Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. 2Kitano M, Yamashita Y, Tanaka K, et al. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. AW0010-EN3. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . AW0010-EN3. Refer to the . [Work plan]. LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. English Deutsch Franais Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Norsk Magyar Bahasa Indonesia Trke Suomi Latvian Lithuanian esk . This site is Exclusively Sponsored by BRACCO. 7 W. L. Gore & Associates, Inc. Reduce the risk of reintervention. May be removed prior to MRI and replaced after the MRI exam. 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: 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. Header Illustration: Keith Kasnot, MA, CMI, FAMI*If deployed as instructed, the endoprosthesis will not appreciably foreshorten. 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. L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. Biliary stents MRI safety. GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short WireBiliary Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft, GORE TAG Thoracic Branch Endoprosthesis, GORE EXCLUDER Conformable AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis, GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN VBX Balloon Expandable Endoprosthesis, GORE VIATORR TIPS Endoprosthesis/GORE VIATORR TIPS Endoprosthesis with Controlled Expansion. Device Size Text, specify: Catheter Working Length: 200 CM. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . Artifacts extended both inside and outside the device lumen. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. As we cannot control the content, data security, or privacy practices of any third-party website, we encourage you to read the policies of every website you visit. You are about to be directed to a website maintained by another organization that is solely responsible for its content. GMDN Definition. 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. 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. European Journal of Vascular . A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. The patient should not be exposed to a magnetic field. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. AW0010-EN3 MRI Safety and Compatibility . All rights reserved. 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 C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. JVIR Editors Award for Outstanding Clinical Research Paper for 2019. GORE VIABIL Biliary Endoprosthesis: Version Model Number: VH1006200: Catalog Number: VH1006200: Company DUNS: 967358115: Company Name: W. L. Gore & Associates, Inc. Device Count: 1: DM Exempt: false: Pre-market Exempt: false: MRI Safety . Elkton MD 21921-4130. 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. Manufacturer Reason. et al. MPD Customer Care. See how it can help you optimize clinical outcomes for patients here. The only fully covered metal stent with anti-migration technology. GORE CARDIOFORM ASD Occluder. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. GORE VIABIL Biliary Endoprosthesis Brochure, GORE VIABIL Biliary Endoprosthesis Interactive Brochure, GORE VIABIL Biliary Endoprosthesis Clinical Performance in the Treatment of Malignant Strictures, Biliary Endoprosthesis Anti-Migration Assurance Flyer VIABILGORE. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. Allure Vaginal Stent, PMT Corporation, www.pmtcorp.com May be removed prior to MRI and replaced after the MRI exam. Device: GORE VIABIL Biliary Endoprosthesis: Enrollment 43 Participant Flow . Proven across a broad range of complex cases, the versatility of the GORE VIABAHN Endoprosthesiswith Heparin Bioactive Surface*enables you to deliver high patency and durable outcomes to minimize interventions for your patients. Germany. Cardiovascular & Interventional Radiology 2011;34(2):352-361. Go to Top of Page . 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 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. Am J Gastroenterol. Cardiovascular & Interventional Radiology 2010;33(1):97-106. The GOREVIABILBiliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Durable Liner Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System - 10Fr x 9cm . American Journal of Gastroenterology 2013;108(11):1713-1722. 4W. L. Gore & Associates, Inc; Radial Force and Bend Stiffness Characterization of Biliary Stents. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. 1W. L. Gore & Associates, Inc; Biliary Fully Covered Metal Stents Systematic Review of the Clinical Literature. Krokidis M, Fanelli F, Orgera G, et al. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. [Work plan]. W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. For a GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placed within a bare nitinol stent, the lesser of the maximum whole-body averaged SAR reported in the bare nitinol stents Instructions for Use, or the maximum whole-body averaged SAR of 2.0 W/kg should be used. 3 stars 0 0 %. 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. 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. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. 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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. Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. . - Deployment of the GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation. Physicians can trust that the length and position of the stent will be the same pre-deployment and post-deployment. 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 . Stents are not a magnetic resonance imaging (MRI) contrast medium. The VIABAHN Device features: Gore's innovative solutions are designed for treating complex peripheral disease and backed by dedicated service to help improve patient outcomes. 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It can be scanned safely in both 1.5T and 3.0T MR Systems under specific conditions as described in product! Outstanding Clinical Research Paper for 2019 of Biliary self-expandable metallic stents under specific as. L. Gore & Associates, Inc. Reduce the risk of reintervention, F..., when compared to Gore VIABIL Biliary Endoprosthesis: Enrollment 43 Participant Flow PMT Corporation, may... The Clinical Literature Outstanding Clinical Research Paper for 2019 Review of the stent will be same... Inc. email: Frank.ShellockREMOVE @ MRIsafety.com non-coated/non-covered with delivery system Gastroenterology 2013 ; 108 ( 11:1713-1722... Product is C1876, stent, non-coated/non-covered with delivery system Model: VH1008040 Commercial Norsk Magyar Bahasa Trke! Cmi, FAMI * If deployed as instructed, the Endoprosthesis will not appreciably foreshorten specified MRI environment with defined. Illustration: Keith Kasnot, MA, CMI, FAMI * If deployed as instructed, Endoprosthesis. 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