W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. Coils, Filters, Stents, and Grafts More. GORE VIABIL Biliary Endoprosthesis: Version Model Number: VH1008200: Catalog Number: VH1008200: Company DUNS: 967358115: Company Name: W. L. Gore & Associates, Inc. Device Count: 1: DM Exempt: false: Pre-market Exempt: false: MRI Safety . Flagstaff, AZ; 2012. Gastrointestinal Endoscopy 2009;70(1):37-44. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . You are here: Home 1 / Clearway in the Community 2 / Uncategorised 3 / gore viabil stent mri safety. VIABAHN Endoprosthesis8-mm x 25-cmsingle versionNitinolW.L. 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. 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. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. The artifact may extend up to 10 mm from the implant. 2013 Nov;108(11):1713-22. Evolution Biliary Controlled-Release Stent - Uncovered: Clinical Case with Dr. Bruno . 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. Am J Gastroenterol. Backed by the CONMED Biliary Assurance Program Refer to the Instructions for Use for additional information. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. You are about to be directed to a website maintained by another organization that is solely responsible for its content. 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. Krokidis M, Fanelli F, Orgera G, et al. 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. Cardiovascular & Interventional Radiology 2011;34(2):352-361. Stents are not a magnetic resonance imaging (MRI) contrast medium. GORE SEAMGUARD Staple Line ReinforcementW.L. 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: 15 minutes of scanning (i.e. 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 American Journal of Gastroenterology 2013;108(11):1713-1722. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. Evolution Family of Stents: Malignant Tumor Located in the Head of the . The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. Proven to Minimize the Risk of Reintervention, Higher Primary Patency Rates Than the Competition, Biliary Endoprosthesis Anti-Migration Assurance Flyer. 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. MR Conditional High Axial Force: SEMS with high Af do not conform well to curved biliary anatomy. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. MR Conditional . Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System - 10Fr x 9cm . 29-32 Studies of peripherally . The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . GMDN Names and Definitions: Copyright GMDN Agency 2015. You are about to switch country/language. 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. 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. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists . For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. This site is Exclusively Sponsored by BRACCO. The GOREVIABILBiliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Device Size Text, specify: Catheter Working Length: 200 CM. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Unique anti-migration technology aids in reducing the risk of reinterventions. ALIMAXX-B Uncovered Biliary Stent10-mm x 80-mmNickel TitaniumAlveolus, Inc.Charlotte, NC, ALIMAXX-BBiliary StentUncovered Biliary StentMerit EndotekMerit Medical Systems, Inc.South Jordan, UT, ALIMAXX-ES StentMerit Medical, www.merit.com, ALIMAXX-ESEsophageal StentMerit EndotekMerit Medical Systems, Inc.South Jordan, UT, Allen wrenchWH-1/4Ampco Safety ToolsGarland, TX, AlloMax Surgical GraftBard Plastic Surgery, www.bardps.com. With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VH1008040 Commercial . Higher primary patency 800-528-8763. Learn about our Anti-Migration Assurance Program. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. ALN Vena Cava Filter, 12 Legs with HookALN Implants Chirurgicaux, www.aln2b.com, ALN Vena Cava Filter, 12 LegsALN Implants Chirurgicaux, www.aln2b.com, ALN Vena Cava Filter316L SSALN Implants Chirurgicaux, www.aln2b.com, Alpha (M) Magnetic Implant, Bone Conduction Hearing SystemSophono, Inc., www.sophono.com, AlphaGRAFT Demineralized Bone MatrixAlphatec Spine Inc., www.alphatecspine.com, AltaSeal Tubal Occlusion Implant (TOI)Alta Science, www.altascience.ie, ALTO Partial and Total Prosthesis Device Family, ALTO Partial and Total Prosthesis; Family Product Number(s), 6XX; Device Material(s), Titanium, HA (hydroxyapatite), Silicone Grace Medicalhttp://www.g, Ambu Disposable PEEP ValveAmbuXiamen, China, Ambu Mark IV Baby ResuscitatorAmbu A/S, www.ambuusa.com, Ambu SPUR II Infant ResuscitatorAmbuXiamen, China, Ambulatory Halo Systemhalo and cervical fixation. MPD Customer Care. 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. Some placeholder content for the collapse component. 3Isayama H, Mukai T, Itoi T, et al. Durable Liner For additional information regarding MRI, please refer to the product Instructions for . Open the catalog to page 6. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. 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. 28 Other ex vivo studies of various coronary stents also led to the conclusions that MR examination with those stents tested would be safe. Manufacturer Reason. Under these conditions, the central portion of the lumen of the aortic component was visible. 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. Gastrointestinal Endoscopy 2009;70(1):37-44. Polymer-metal biliary stent, non-bioabsorbable. Vivendi Bovine Pericardium Patch with L-Hydro. GORE VIABIL Biliary Endoprosthesis (00733132638864), Polymer-metal biliary stent, non-bioabsorbable. catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V. Gore and Associates, www.goremedical.com, GORE-TEX Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch W.L. 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 . Deutsch. 5Isayama H, Nakai Y, Toyokawa Y, et al. Artifacts extended both inside and outside the device lumen. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Only applicable to Gore VIABIL delivered endoscopically. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . 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. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. 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 . Non-clinical testing has demonstrated that the Valiant thoracic stent graft is MR-conditional. The product you are looking for does not exist for the target country/language. Conditional 6 More. The stent removal is considered safe when the Study Device is removed successfully and without SAEs. Visian TICL (Toric version, Implantable Contact Lens)STAAR Surgical Company, Staar www.staar.com, Visistat Skin Stapler (Staple)Hemostatic ClipTeleflex Medical, www.teleflex.com, Vistafix ProsthesisCochlear Corporation, www.cochlear.com, Visu-loc ligation clip, hemostatic clipMicroline Surgical, www.microlinesurgical.com, Visu-Lochemostatic clipwww.microlinesurgical.com, Vital-Port (polysulfone, titanium)vascular access portCook, www.cookmedical.com, Vital-Port SystemDual Chamber, Titanium PetiteVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemDual Chamber, Titanium StandardVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemMRI PetiteVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemMRI StandardVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemStandard SizeVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemTitanium for Peripheral Placement MiniVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemTitanium MiniVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemTitanium Petite StandardVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port SystemTitanium PetiteVascular Access PortCook Medical, Inc.http://www.cookmedical.com, Vital-Port, Dual (Polysulfone, Titanium)Vascular Access PortCook, www.cookmedical.com, VIVAL Coronary StentAvantec VascularSunnyvale, CA, Vivendi Bovine Pericardium Patch with L-HydroLabcor Laboratorios Ltda., www.labcor.com, VivoKey Spark 2 (13.56MHz NFC Type 4 ISO14443A passive transponder using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. 7 W. L. Gore & Associates, Inc. Reduce the risk of reintervention. 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 . English. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. Cardiovascular & Interventional Radiology 2010;33(1):97-106. Gastrointestinal Endoscopy 2012;76(1):84-92. Gore & Associates, Inc. 301 Airport Rd. For a full version of conditions, please see product Instructions for Use (IFU). W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. 1W. L. Gore & Associates, Inc. Migration Summary for GORE VIABIL Biliary Endoprosthesis and BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent. 6Subject to terms and conditions, MCM2017139 Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Biliary stents MRI safety. Piazza M, Squizzato F, Dall'Antonia A, et al. Physicians can trust that the length and position of the stent will be the same pre-deployment and post-deployment. The only fully covered metal stent with anti-migration technology. The VIABAHN Device is aleader among stent grafts. GMDN Definition. The GORE VIABAHN Endoprosthesis is a leader among stent grafts. Polymer-metal biliary stent, non-bioabsorbable. for Recall. GORE CARDIOFORM Septal Occluder. 3. For Additional Information Contact. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. * In addition, the GORE VIABIL Biliary Endoprosthesis remains in the same location throughout deployment, eliminating the need to use a push-pull technique. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis9-mm x 15-cmNitinolW. 4W. L. Gore & Associates, Inc; Radial Force and Bend Stiffness Characterization of Biliary Stents. WP103837. A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. 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. **p<0.00000001, when compared to GORE VIABIL Biliary Endoprosthesis migration rates. Kitano M, Yamashita Y, Tanaka K, et al. [Work plan]. This panel is hidden by default but revealed when the user activates the relevant trigger. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. You are about to be directed to a website maintained by another organization that is solely responsible for its content. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Biliary Guidewires. Flagstaff, AZ; 2019. gore viabil stent mri safety 21st May 2022 . Patency, or the ability for a stent to remain open and unoccluded, is a crucial characteristic of any Self-Expanding Metal Stent (SEMS). [Literature Summary]. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. The GOREVIABILShort Wire Biliary Endoprosthesisis a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Unique anti-migration technology aids in reducing the risk of reinterventions. 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. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. 2022 MRI Textbook. 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. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . See how it can help you optimize clinical outcomes for patients here. EN. 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. MRI Compatibility: Stent Graft Compatibility: Patient Limitations: CardioMEMS, Inc. . [Work plan]. JVIR Editors Award for Outstanding Clinical Research Paper for 2019. 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. 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. May be removed prior to MRI and replaced after the MRI exam. Header Illustration: Keith Kasnot, MA, CMI, FAMI*If deployed as instructed, the endoprosthesis will not appreciably foreshorten. L. Gore & Associates, Inc.www.goremedical.com, GORE TIGRIS Vascular Stent, All SizesW. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Refer to the . Gastrointestinal Endoscopy 2012;76(1):84-92. . Deutschland. The tables show the Gore devices that are labeled as MR conditional. This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3, Malignant biliary stricture migration rate comparison1 You are about to switch country/language. 2022 CONMED Corporation. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Time Frame Upon Removal Outcome Measure Data Analysis Population Description. Catheter(PUR Radiopaque)intravenous (I.V.) The information on this page provides only a summary of MR conditions for each device and is intended as a reference for the U.S. only. Cardiovascular & Interventional Radiology 2011;34(2):352-361. catheterSmiths Medical ASD Inc., Southington, CT, Vibrant SOUNDBRIDGE, VORP 502 ImplantVibrating Ossicular ProsthesisMED-EL, www.medel.com, Vibrant SOUNDBRIDGE, VORP 503 ImplantVibrating Ossicular ProsthesisMED-EL, www.medel.com, Vibrant SoundbridgeSymphonix Devices, Inc.San Jose, CA, Vici Venous StentVeniti, Inc., www.venitimedical.com, Virtuoso Implantable Cardioverter Defibrillator, ICDMedtronic, Inc., www.medtronic.com, Visi-Pro Balloon Expandable StentCovidien and ev3 Inc., www.ev3.net, Visi-Pro Biliary StentCovidien and ev3 Inc., www.ev3.net, Visian ICL (Implantable Contact Lens)STAAR Surgical Company, Staar www.staar.com. 2Isayama H, Nakai Y, Toyokawa Y, et al. - Deployment of the GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation. RX Only. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . 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. Data on File. MRI Safety and Compatibility . Gore & Associates Flagstaff, AZ www.goremedical.com GORE CARDIOFORM ASD Occluder. All rights reserved. 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. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Optimal Conformability European Journal of Vascular . per pulse sequence). Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. Videos Evolution Biliary Controlled-Release Stent - Uncovered Animation. Reproduced with Permission from the GMDN Agency. Were here to help! Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. 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. Libertyville, IL. Am J Gastroenterol. Proven to Minimize the Risk of Reintervention1, Optimal Conformance to Ductal Anatomy2,3,4. 1. Not applicable to VIABIL devices for percutaneous delivery. VIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. et al. The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. 2Kitano M, Yamashita Y, Tanaka K, et al. 1W. L. Gore & Associates, Inc; Biliary Fully Covered Metal Stents Systematic Review of the Clinical Literature. GMDN Definition. What MRI safety information does the labeling contain? W.L. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. The GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. 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 . Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. [Literature Summary]. Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. Based on a number of clinical publications, GORE VIABIL Biliary Endoprosthesis demonstrates substantially lower migration rates than the competition. WALLSTENT Endoprosthesis. Kitano M, Yamashita Y, Tanaka K, et al. 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. Germany. Measurement of radial and axial forces of biliary self-expandable metallic stents. Subjects with stent removal data available . Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. GORE VIABIL Biliary Endoprosthesis Assurance Brochure. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185. 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 . GORE TAG . WP111272. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Elkton MD 21921-4130. The CBAS Heparin Surface on the GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of stable, covalent, end-point attached heparin of porcine origin. 96.9% primary patency1. Safe Mobility; Skin Health; Cardiac and Peripheral Fluid Management; Clinical Nutrition; Emergency Medical Services; Foot and Ankle Surgery ; . using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. Unique anti-migration technology aids in reducing the risk of reinterventions. 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 . 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. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug . Gore's Anti-Migration Assurance Program offered through ConMed. 2022 CONMED Corporation. The information on this page is current as of November 2022. 3 stars 0 0 %. Demonstrated low migrations Fully covered anti-migration fins securely hold the device within the duct to minimize the risk of migration, with a reported 0.0-1.4% migration rate range. The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. Go to Top of Page . The only fully covered metal stent with anti-migration technology. 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. 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. Advanix Biliary Stents; United Kingdom. AW0010-EN3. 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. 6Kitano M, Yamashita Y, Tanaka K, et al.
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