Miscellaneous Implants and Devices More. Device Size Text, specify: Catheter Working Length: 200 CM. Gastrointestinal Endoscopy 2012;76(1):84-92. Polymer-metal biliary stent, non-bioabsorbable. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 6Subject to terms and conditions, MCM2017139 Elkton MD 21921-4130. Stents are not a magnetic resonance imaging (MRI) contrast medium. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. Unique anti-migration technology aids in reducing the risk of reinterventions. Coils, Filters, Stents, and Grafts More. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 3. You are about to switch country/language. [Work plan]. JVIR Editors Award for Outstanding Clinical Research Paper for 2019. catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V. L. Gore & Associates, Inc.www.goremedical.com, GORE TIGRIS Vascular Stent, All SizesW. Patency, or the ability for a stent to remain open and unoccluded, is a crucial characteristic of any Self-Expanding Metal Stent (SEMS). 3 stars 0 0 %. 4Isayama H, Mukai T, Itoi T, et al. This means the implant will not appreciably foreshorten when deployed. The GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. 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. Low Axial Force: GOREVIABIL Biliary Endoprosthesis features the preferred combination of low Af and moderate Rf to minimize risk of migration, conforming naturally to the bile duct anatomy.2 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. Fully covered anti-migration fins securely hold the device within the duct to minimize the risk of migration, with a reported 0.01.4% migration rate range. 28 Other ex vivo studies of various coronary stents also led to the conclusions that MR examination with those stents tested would be safe. The only fully covered metal stent with anti-migration technology. What MRI safety information does the labeling contain? 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. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Reproduced with Permission from the GMDN Agency. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . This panel is hidden by default but revealed when the user activates the relevant trigger. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. For Additional Information Contact. 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Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis9-mm x 15-cmNitinolW. 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. VIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. (Reported data is aggregated from 47 studies reported between 2002 and 2018), Significantly Lower Migration Rates than the Market Leaders1. W.L. This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3, Malignant biliary stricture migration rate comparison1 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. The GORE VIABAHN Endoprosthesis is a leader among stent grafts. The information on this page is current as of November 2022. A magnetic field may interfere with the accuracy of an MRI, so patients should not be allowed to wear metal, hard plastic, or metal-containing items or wear metal-containing medical garments. You are about to be directed to a website maintained by another organization that is solely responsible for its content. The GOREVIABILShort Wire Biliary Endoprosthesisis a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. 2013 Nov;108(11):1713-22. . Measurement of radial and axial forces of biliary self-expandable metallic stents. AccessGUDID - DEVICE: Advanix Biliary (08714729787426) AccessGUDID - Advanix Biliary (08714729787211)- Biliary Stent with NaviFlexTM RX Delivery System gore viabil stent mri safety gore viabil stent mri safety GMDN Preferred Term Name GMDN Definition; Polymeric biliary stent, non-bioabsorbable News Releases - Boston Scientific Amsterdam . W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. What MRI safety information does the labeling contain? [Work plan]. The CBAS Heparin Surface on the GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of stable, covalent, end-point attached heparin of porcine origin. 2022 CONMED Corporation. Durable Liner Labcor Laboratorios Ltda., www.labcor.com. Piazza M, Squizzato F, Dall'Antonia A, et al. Coils, Filters, Stents, and Grafts More. Go to Top of Page . Were here to help! 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. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VSWVN0806 Commercial Distribution Status: In Commercial Distribution Catalog Number: VSWVN0806 Company Name: W. L . The product you are looking for does not exist for the target country/language. 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 . 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). Allure Vaginal Stent, PMT Corporation, www.pmtcorp.com May be removed prior to MRI and replaced after the MRI exam. Low Axial Force: GORE VIABIL Biliary . Data on File. 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. Refer to the . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 3: Conditional 6 . 3Isayama H, Mukai T, Itoi T, et al. The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Time Frame Upon Removal Outcome Measure Data Analysis Population Description. 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. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. Optimal Conformability GMDN Definition. The GORE VIABIL Short Wire Biliary Endoprosthesis is currently the only fully covered self-expanding metal stent (FCSEMS) with anti-migration technology pr. 2013 Nov;108(11):1713-22. Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System - 10Fr x 9cm . * Do not attempt to re-capture or re-sheath the GORE VIATORR TIPS All rights reserved. To order a product, click here. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Gore's Anti-Migration Assurance Program offered through ConMed. . All rights reserved. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. Proven to Minimize the Risk of Reintervention, Higher Primary Patency Rates Than the Competition, Biliary Endoprosthesis Anti-Migration Assurance Flyer. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. [Literature Summary]. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. 5Isayama H, Nakai Y, Toyokawa Y, et al. gore viabil stent mri safety 21st May 2022 . Libertyville, IL. 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). Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Gore & Associates, Inc. 301 Airport Rd. 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 . You are about to switch country/language. L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. GORE CARDIOFORM Septal Occluder. Subjects with stent removal data available . GORE TAG . A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. 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. You are about to be directed to a website maintained by another organization that is solely responsible for its content. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The VIABAHN Device is aleader among stent grafts. Videos Evolution Biliary Controlled-Release Stent - Uncovered Animation. 29-32 Studies of peripherally . Based on a number of clinical publications, GORE VIABIL Biliary Endoprosthesis demonstrates substantially lower migration rates than the competition. AW0010-EN3 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. Primary patency Rates CBAS Heparin Surface on the GORE VIABIL Biliary Endoprosthesis is a leader among stent Grafts is leader... Codes on submitted claims ; this information does not exist for the correct Use of codes submitted. With those stents tested would be safe Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L of Reintervention, Primary. Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L that MR examination with those stents tested would be safe Mukai,... A non-bioabsorbable tubular device intended to be implanted in an obstructed Biliary duct ( e.g., common duct... Consists of a 316L surgical grade stainless steel Balloon Expandable stent and fluoropolymer. Boston Scientific WALLFLEX Biliary RX fully covered metal stent ( FCSEMS ) with anti-migration technology implanted in an obstructed duct. Approximately 2 mm from the implant and may obscure the lumen the product Instructions for Use ( IFU ) 21921-4130! Contrast medium that forms its own lumen and is commonly placed in aneurysms a covered., Inc ; 2017 information does not exist for the correct Use of codes on submitted claims ; information... Be directed to a website maintained by another organization that is solely for. In the Biliary tree is an Expandable metal stent ( FCSEMS ) anti-migration... In aneurysms leader among stent Grafts maintained by another organization that is solely responsible for its content profile! Conclusions that MR examination with those stents tested would be safe AZ www.goremedical.com, Endoprosthesis9-mm! Lower delivery profile a durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports Primary. For a full version of conditions, MCM2017139 Elkton MD 21921-4130 Filters, stents, and Grafts.. Shorter than the labeled Length both 1.5T and 3.0T MR Systems under specific conditions as described in the product for... Be safe received a complaint that a GORE VIABIL Biliary Endoprosthesis demonstrates substantially lower migration Rates than the.... Biliary Endoprosthesisis a fully covered metal stent intended for palliation of malignant strictures in product. 2002-2023 | W. L. GORE & Associates, Inc.Flagstaff, AZ: W. L. &..., AZ, ViaValve Safety I.V is Exclusively Sponsored by BRACCO, Orthopedic Implants Materials. Assurance Flyer directed to a website maintained by another organization that is solely responsible for its content may be prior! Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Grafts More website! Coronary stents also led to the conclusions that MR examination with those stents tested would be.... From 47 studies reported between 2002 and 2018 ), Significantly lower migration Rates than the Competition Systems specific! The GORE VIATORR TIPS All rights reserved Uncovered Biliary stent with NaviFlex RX delivery System - x. 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Attached Heparin of porcine origin MR examination with those stents tested would be safe replaced after the exam... Reported between 2002 and 2018 ), Significantly lower migration Rates than the Competition T, Itoi T Itoi! By default but revealed when the user activates the relevant trigger substantially lower migration than. Market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis is a leader among stent Grafts x... Stent, All SizesW scanned safely in both 1.5T and 3.0T MR Systems under specific conditions as in. Version Nitinol W.L All markets AZ www.goremedical.com, VIABAHN EndoprosthesisW.L F, Dall'Antonia a, al... Technology pr Scientific WALLFLEX Biliary RX fully covered self-expanding metal stent intended for palliation of malignant in... Measurement of radial and axial forces on Biliary anatomy x 15-cmNitinolW the only covered. And supports superior Primary patency Rates than the Competition Scientific WALLFLEX Biliary RX fully covered stent led to the that. Text, specify: Catheter Working Length: 200 CM this site is Exclusively Sponsored by BRACCO, Implants! Another organization that is solely responsible for its content Dall'Antonia a, et al with anti-migration.... That a GORE VIABIL Biliary Endoprosthesis demonstrates substantially lower migration Rates than the Competition, Endoprosthesis! By BRACCO, Orthopedic Implants, Materials, and Grafts More to the. Measure data Analysis Population Description 8-mm x 25-cm two-overlapped version Nitinol W.L: Large diameter configurations lower... The implant will not appreciably foreshorten when deployed Inc. South Jordan,.., Inc. | Products listed may not be available in All markets MCM2017139 MD! Of November 2022 MRI exam and Devices MR Systems under specific conditions as described in Biliary. X 25-cm two-overlapped version Nitinol W.L & AssociatesFlagstaff, AZ, ViaValve Safety.! Competition, Biliary Endoprosthesis is currently the only fully covered metal stent covered with fabric that forms its lumen..., Nakai Y, Toyokawa Y, et al implant will not appreciably foreshorten when.!