MPD Customer Care. Gore's Anti-Migration Assurance Program offered through ConMed. Device Size Text, specify: Catheter Working Length: 200 CM. GORE CARDIOFORM Septal Occluder. Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Safe Mobility; Skin Health; Cardiac and Peripheral Fluid Management; Clinical Nutrition; Emergency Medical Services; Foot and Ankle Surgery ; . MRI Safety and Compatibility . 96.9% primary patency1. 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). 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Kitano M, Yamashita Y, Tanaka K, et al. Patency, or the ability for a stent to remain open and unoccluded, is a crucial characteristic of any Self-Expanding Metal Stent (SEMS). Deutschland. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. - Deployment of the GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation. 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. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. Durable Liner 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 . GORE SEAMGUARD Staple Line ReinforcementW.L. 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. 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. Kitano M, Yamashita Y, Tanaka K, et al. L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. gore viabil stent mri safety 21st May 2022 . 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. 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. Krokidis M, Fanelli F, Orgera G, et al. 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. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L. European Journal of Vascular . 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: The number of coronary stents may be over half a million world-wide. 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. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. 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. The patient should not be exposed to a magnetic field. Flagstaff, AZ; 2012. Polymer-metal biliary stent, non-bioabsorbable. 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. 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 . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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: 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 Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. 29-32 Studies of peripherally . Measurement of radial and axial forces of biliary self-expandable metallic stents. GMDN Definition. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. Clinical Data - Gore Medical. This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3, Malignant biliary stricture migration rate comparison1 JVIR Editors Award for Outstanding Clinical Research Paper for 2019. Coils, Filters, Stents, and Grafts More. 6Kitano M, Yamashita Y, Tanaka K, et al. Biliary stents MRI safety. GORE VIABIL Biliary Endoprosthesis offers substantiated evidence in studies that demonstrate sustained long-term patency. Backed by a growing body of clinical data, the VIABAHN Device has become a go-to device for physicians most challenging cases. Coils, Filters, Stents, and Grafts More. VivoKey Spark 2 (13.56MHz NFC Type 4 ISO14443A passive transponder. 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. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . Am J Gastroenterol. The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. All rights reserved. For additional information regarding MRI, please refer to the product Instructions for . Flagstaff, AZ; 2019. English. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. WALLSTENT Endoprosthesis. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Gastrointestinal Endoscopy 2009;70(1):37-44. 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. Were here to help! Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. 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. Refer to the Instructions for Use for additional information. Evolution Family of Stents: Malignant Tumor Located in the Head of the . Libertyville, IL. 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 . 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. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Allure Vaginal Stent, PMT Corporation, www.pmtcorp.com May be removed prior to MRI and replaced after the MRI exam. 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. using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. 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. Proven to Minimize the Risk of Reintervention1, Optimal Conformance to Ductal Anatomy2,3,4. For a full version of conditions, please see product Instructions for Use (IFU). Gore & Associates, Inc. 301 Airport Rd. Learn about our Anti-Migration Assurance Program. 1W. L. Gore & Associates, Inc; Biliary Fully Covered Metal Stents Systematic Review of the Clinical Literature. 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. Conditional 6 More. Deutsch. WP111272. Gore & Associateshttp://www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L. 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. 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. Labcor Laboratorios Ltda., www.labcor.com. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis9-mm x 15-cmNitinolW. Piazza M, Squizzato F, Dall'Antonia A, et al. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . GORE TAG Conformable Thoracic Stent Graft. 2022 CONMED Corporation. The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. 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. 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 . The only fully covered metal stent with anti-migration technology. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VSWVN0806 Commercial Distribution Status: In Commercial Distribution Catalog Number: VSWVN0806 Company Name: W. L . 2Kitano M, Yamashita Y, Tanaka K, et al. Higher primary patency 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. All current stents are MRI safe and MRI can be done . This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists . A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Elkton MD 21921-4130. VIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. 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. per pulse sequence). **p<0.00000001, when compared to GORE VIABIL Biliary Endoprosthesis migration rates. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. This panel is hidden by default but revealed when the user activates the relevant trigger. (Reported data is aggregated from 47 studies reported between 2002 and 2018), Significantly Lower Migration Rates than the Market Leaders1. 3: Conditional 6 . The CBAS Heparin Surface on the GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of stable, covalent, end-point attached heparin of porcine origin. 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. VIABAHN Endoprosthesis8-mm x 25-cmsingle versionNitinolW.L. GORE CARDIOFORM ASD Occluder. Open the catalog to page 6. 28 Other ex vivo studies of various coronary stents also led to the conclusions that MR examination with those stents tested would be safe. Unique anti-migration technology aids in reducing the risk of reinterventions. 800-528-8763. May be removed prior to MRI and replaced after the MRI exam. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Demonstrated low migrations Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VH1008040 Commercial . 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. November 28, 2020. the pain in the heart bones on gore viabil stent mri safety . Gastrointestinal Endoscopy 2009;70(1):37-44. 15 minutes of scanning (i.e. Evolution Biliary Controlled-Release Stent - Uncovered: Clinical Case with Dr. Bruno . 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. WP103837. The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. RX Only. Gore & Associates Flagstaff, AZ www.goremedical.com Subjects with stent removal data available . C-codes are used for hospital outpatient device reporting for Medicare and some private payers. What MRI safety information does the labeling contain? The GORE VIABAHN Endoprosthesis is a leader among stent grafts. See how it can help you optimize clinical outcomes for patients here. Miscellaneous Implants and Devices More. Unique anti-migration technology aids in reducing the risk of reinterventions. GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short Wire Biliary Endoprosthesis. The tables show the Gore devices that are labeled as MR conditional. Unique anti-migration technology aids in reducing the risk of reinterventions. Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System - 10Fr x 9cm . 3Isayama H, Mukai T, Itoi T, et al. 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
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