. Evolution Biliary Controlled-Release Stent - Uncovered: Clinical Case with Dr. Bruno . You are here: Home 1 / Clearway in the Community 2 / Uncategorised 3 / gore viabil stent mri safety. 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. Unique anti-migration technology aids in reducing the risk of reinterventions. Reproduced with Permission from the GMDN Agency. See how it can help you optimize clinical outcomes for patients here. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. 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. What MRI safety information does the labeling contain? 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. For a full version of conditions, please see product Instructions for Use (IFU). Shellock R & D Services, Inc. email: [email protected]. The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. Flagstaff, AZ: W. L. Gore & Associates, Inc. GORE VIABIL Biliary Endoprosthesis - Product Brochure, GORE VIABIL Biliary Endoprosthesis - Interactive Brochure, Clinical Performance of GORE VIABIL Biliary Endoprosthesis in Treatment of Malignant Strictures - White Paper Summary, Ask us anything. English. Device: GORE VIABIL Biliary Endoprosthesis: Enrollment 43 Participant Flow . [Literature Summary]. High Axial Force: SEMS with high Af do not conform well to curved biliary anatomy. Currently, different kinds of stents with different shapes, sizes, calibers, and materials have been introduced. The tables show the Gore devices that are labeled as MR conditional. Gore & Associateshttp://www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L. 29-32 Studies of peripherally . Elkton MD 21921-4130. Gore's Anti-Migration Assurance Program offered through ConMed. This site is Exclusively Sponsored by BRACCO. Gore and Associates, www.goremedical.com, GORE-TEX Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch W.L. [Work plan]. All rights reserved. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Unique anti-migration technology aids in reducing the risk of reinterventions. Cardiovascular & Interventional Radiology 2010;33(1):97-106. Polymer-metal biliary stent, non-bioabsorbable. GORE TAG Conformable Thoracic Stent Graft. for Recall. Device Size Text, specify: Catheter Working Length: 200 CM. Not applicable to VIABIL devices for percutaneous delivery. Deutsch. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. GORE VIABIL Biliary Endoprosthesis is the only non-foreshortening fully covered metal stent in the market. Evolution Family of Stents: Malignant Tumor Located in the Head of the . WP111272. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L. 3. 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). Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Polymer-metal biliary stent, non-bioabsorbable. 3: Conditional 6 . Demonstrated low migrations 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. Cardiovascular & Interventional Radiology 2011;34(2):352-361. 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. Cardiovascular & Interventional Radiology 2010;33(1):97-106. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. GMDN Definition. - Deployment of the GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation. Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. 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 . The neurologist and radiologist are frequently confronted with cardiac patients who have had a recent carotid or coronary stent implanted and present with an acute and unrelated stroke for which an MRI is recommended. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. The patient should not be exposed to a magnetic field. 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A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. 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: Germany. 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. 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. Unique anti-migration technology aids in reducing the risk of reinterventions. AW0010-EN3 The product you are looking for does not exist for the target country/language. You are about to be directed to a website maintained by another organization that is solely responsible for its content. 2022 CONMED Corporation. 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. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. Learn about our Anti-Migration Assurance Program. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Catheter(PUR Radiopaque) intravenous (I.V.) Piazza M, Squizzato F, Dall'Antonia A, et al. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . Allure Vaginal Stent, PMT Corporation, www.pmtcorp.com May be removed prior to MRI and replaced after the MRI exam. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VSWVN0806 Commercial Distribution Status: In Commercial Distribution Catalog Number: VSWVN0806 Company Name: W. L . It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . Subjects with stent removal data available . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Manufacturer Reason. Durable Liner You are about to be directed to a website maintained by another organization that is solely responsible for its content. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Safe More. Unique anti-migration technology aids in reducing the risk of reinterventions. GORE VIABIL Biliary Endoprosthesis Assurance Brochure. The GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. MRI Safety and Compatibility . AW0010-EN3. 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: Under the program, Gore will provide a replacement device of identical dimensions for use with a patient whose device moves out of place within one year post-implantation. American Journal of Gastroenterology 2013;108(11):1713-1722. 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. catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. 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. L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . Low Axial Force: GORE VIABIL Biliary . Go to Top of Page . 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You are about to switch country/language. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis9-mm x 15-cmNitinolW. Gore & Associates Flagstaff, AZ www.goremedical.com MR Conditional 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. 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. Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. The product you are looking for does not exist for the target country/language. Warning: The safety and effectiveness of this device for use in the vascular system have not been established. What MRI safety information does the labeling contain? 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 . 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