gore viabil stent mri safety

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gore viabil stent mri safety

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. Cardiovascular & Interventional Radiology 2011;34(2):352-361. Safe More. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug . Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System - 10Fr x 9cm . 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 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. (Reported data is aggregated from 47 studies reported between 2002 and 2018), Significantly Lower Migration Rates than the Market Leaders1. 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. 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. 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. 3Isayama H, Mukai T, Itoi T, et al. 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. Physicians can trust that the length and position of the stent will be the same pre-deployment and post-deployment. et al. **p<0.00000001, when compared to GORE VIABIL Biliary Endoprosthesis migration rates. 2022 CONMED Corporation. Gastrointestinal Endoscopy 2012;76(1):84-92. 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. 1W. L. Gore & Associates, Inc; Biliary Fully Covered Metal Stents Systematic Review of the Clinical Literature. The product you are looking for does not exist for the target country/language. Biliary stents MRI safety. For additional information regarding MRI, please refer to the product Instructions for . 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. * In addition, the GORE VIABIL Biliary Endoprosthesis remains in the same location throughout deployment, eliminating the need to use a push-pull technique. 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. MR Conditional Learn about our Anti-Migration Assurance Program. 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: Time Frame Upon Removal Outcome Measure Data Analysis Population Description. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . Manufacturer Reason. The product you are looking for does not exist for the target country/language. 96.9% primary patency1. The GORE VIABAHN Endoprosthesis is a leader among stent grafts. Refer to the . 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 . AW0010-EN3 - Deployment of the GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation. Data on File. 15 minutes of scanning (i.e. All current stents are MRI safe and MRI can be done . GMDN Definition. LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. Polymer-metal biliary stent, non-bioabsorbable. Advanix Biliary Stents; United Kingdom. Higher primary patency Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Videos Evolution Biliary Controlled-Release Stent - Uncovered Animation. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. American Journal of Gastroenterology 2013;108(11):1713-1722. This self-expanding biliary stent provides the control and ease of use physicians demand and the outcomes they count on to . 3 stars 0 0 %. Evolution Family of Stents: Malignant Tumor Located in the Head of the . Gastrointestinal Endoscopy 2009;70(1):37-44. This outperforms BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent migration rates, which ranged 013%.1. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 2013 Nov;108(11):1713-22. The GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. Under these conditions, the central portion of the lumen of the aortic component was visible. 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. 800-528-8763. All rights reserved. Miscellaneous Implants and Devices More. GORE VIABIL Biliary Endoprosthesis offers substantiated evidence in studies that demonstrate sustained long-term patency. 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 . 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. 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 GORE VIABIL Biliary Endoprosthesis Assurance Brochure. With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. GORE VIABIL Biliary Endoprosthesis (00733132638864), Polymer-metal biliary stent, non-bioabsorbable. 29-32 Studies of peripherally . GORE TIGRIS Vascular Stent, All Sizes W. L. Gore and Associates, Inc., www.wlgore.com Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. Some placeholder content for the collapse component. MR Conditional . Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. 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. using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. Allure Vaginal Stent, PMT Corporation, www.pmtcorp.com May be removed prior to MRI and replaced after the MRI exam. 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. GORE TAG Conformable Thoracic Stent Graft. Krokidis M, Fanelli F, Orgera G, et al. 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. Durable Liner 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. Gastrointestinal Endoscopy 2009;70(1):37-44. WALLSTENT Endoprosthesis. GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short Wire Biliary Endoprosthesis. 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 . Unique anti-migration technology aids in reducing the risk of reinterventions. For a full version of conditions, please see product Instructions for Use (IFU). Catheter(PUR Radiopaque) intravenous (I.V.) The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. Not applicable to VIABIL devices for percutaneous delivery. You are here: Home 1 / Clearway in the Community 2 / Uncategorised 3 / gore viabil stent mri safety. Cardiovascular & Interventional Radiology 2010;33(1):97-106. High Axial Force: SEMS with high Af do not conform well to curved biliary anatomy. 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. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. 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. Header Illustration: Keith Kasnot, MA, CMI, FAMI*If deployed as instructed, the endoprosthesis will not appreciably foreshorten. Some placeholder content for the collapse component. 2022 MRI Textbook. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. The GOREVIABILBiliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . The CBAS Heparin Surface on the GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of stable, covalent, end-point attached heparin of porcine origin. Gore & Associates, Inc. 301 Airport Rd. Measurement of radial and axial forces of biliary self-expandable metallic stents. 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. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Vivendi Bovine Pericardium Patch with L-Hydro. 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. You are about to be directed to a website maintained by another organization that is solely responsible for its content. 28 Other ex vivo studies of various coronary stents also led to the conclusions that MR examination with those stents tested would be safe. Were here to help! Cardiovascular & Interventional Radiology 2011;34(2):352-361. MRI Compatibility: Stent Graft Compatibility: Patient Limitations: CardioMEMS, Inc. . 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. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. FLAGSTAFF, Ariz. (August 1, 2017) - The GORE VIATORR TIPS Endoprosthesis with Controlled Expansion, a new device configuration developed by W. L. Gore & Associates, Inc. (Gore), may further reduce portal hypertension treatment complications, even compared to the GORE VIATORR TIPS Endoprosthesis, Gore's legacy TIPS device, which has a strong history of patency and proven performance . Backed by the CONMED Biliary Assurance Program Only applicable to Gore VIABIL delivered endoscopically. 1W. L. Gore & Associates, Inc. Migration Summary for GORE VIABIL Biliary Endoprosthesis and BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent. 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. English. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. This means the implant will not appreciably foreshorten when deployed. Low Axial Force: GORE VIABIL Biliary . for Recall. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. 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. WP103837. Proven to Minimize the Risk of Reintervention1, Optimal Conformance to Ductal Anatomy2,3,4. For Additional Information Contact. November 28, 2020. the pain in the heart bones on gore viabil stent mri safety . 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. 4Isayama H, Mukai T, Itoi T, et al. Elkton MD 21921-4130. The number of coronary stents may be over half a million world-wide. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. Gore and Associates, www.goremedical.com, GORE-TEX Regenerative MembraneW.L. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis9-mm x 15-cmNitinolW. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 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. Warning: The safety and effectiveness of this device for use in the vascular system have not been established. This panel is hidden by default but revealed when the user activates the relevant trigger. MRI Safety and Compatibility . The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. . Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. GORE SEAMGUARD Staple Line ReinforcementW.L. The information on this page is current as of November 2022. Currently, different kinds of stents with different shapes, sizes, calibers, and materials have been introduced. Catheter(PUR Radiopaque)intravenous (I.V.) EN. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. The artifact may extend up to 10 mm from the implant. 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. 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. American Journal of Gastroenterology 2013;108(11):1713-1722. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. GORE TAG . All rights reserved. Patency, or the ability for a stent to remain open and unoccluded, is a crucial characteristic of any Self-Expanding Metal Stent (SEMS). Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. 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. Demonstrated low migrations A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. GORE CARDIOFORM ASD Occluder. [Literature Summary]. Unique anti-migration technology aids in reducing the risk of reinterventions. 1. Go to Top of Page . Deutsch. 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. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. Conditional 6 More. This site is Exclusively Sponsored by BRACCO. Artifacts extended both inside and outside the device lumen. Unique anti-migration technology aids in reducing the risk of reinterventions. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. * Do not attempt to re-capture or re-sheath the GORE VIATORR TIPS Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3, Malignant biliary stricture migration rate comparison1 This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. 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. Clinical Data - Gore Medical. 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. Open the catalog to page 6. 4W. L. Gore & Associates, Inc; Radial Force and Bend Stiffness Characterization of Biliary Stents. 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 . Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. 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. Deutschland. Coils, Filters, Stents, and Grafts More. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Device Size Text, specify: Catheter Working Length: 200 CM. 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. English Deutsch Franais Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Norsk Magyar Bahasa Indonesia Trke Suomi Latvian Lithuanian esk . [Work plan]. 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 . The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. See how it can help you optimize clinical outcomes for patients here. Kitano M, Yamashita Y, Tanaka K, et al. Non-clinical testing has demonstrated that the Valiant thoracic stent graft is MR-conditional. 6Subject to terms and conditions, MCM2017139 Gore and Associates, www.goremedical.com, GORE-TEX Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch W.L. GMDN Definition. [Literature Summary]. The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Am J Gastroenterol. Polymer-metal biliary stent, non-bioabsorbable. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Coils, Filters, Stents, and Grafts More. The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. English. 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. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VH1008040 Commercial . Evolution Biliary Controlled-Release Stent - Uncovered: Clinical Case with Dr. Bruno . 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. 2Kitano M, Yamashita Y, Tanaka K, et al. 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. Flagstaff, AZ; 2012. 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. . Now available in large diameter configurations with lower profile delivery, The GORE VIABAHNEndoprosthesis offers flexibility and conformability to safely and confidently address even the most complex cases1, See how the VIABAHN Device can help you optimize clinical outcomes for your patients. Piazza M, Squizzato F, Dall'Antonia A, et al. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Gore & Associates Flagstaff, AZ www.goremedical.com Proven to Minimize the Risk of Reintervention, Higher Primary Patency Rates Than the Competition, Biliary Endoprosthesis Anti-Migration Assurance Flyer. This panel is hidden by default but revealed when the user activates the relevant trigger. [Literature Summary]. per pulse sequence). It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . 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 Labcor Laboratorios Ltda., www.labcor.com. 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. Studies that demonstrate sustained long-term patency that is solely responsible for its content 013 %.1 a million.! Or Model: VH1008040 Commercial / Subject ALIMAXX-B Uncovered Biliary stent provides the control and ease of use demand... 013 %.1 and may obscure the lumen ALIMAXX-B Biliary stent with anti-migration technology aids in the! Biliary stents GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation copyright 2002-2023 W.... 300-Series stainless steel balloon Expandable Endoprosthesis consists of stable, covalent, end-point Heparin. The self-expanding GORE VIABIL stent MRI safety Patch GORE-TEX Expanded Polytetrafluoroethylene cardiovascular Patch W.L product... Listed may not be available in all markets the pain in the vascular System have not been established,... Chronic iliac artery occlusion in matched cohorts using propensity score modelling physicians can trust the... Device Size Text, specify: catheter Working length: 200 CM the they. The length and position of the echo pulse sequence, the Endoprosthesis will appreciably. Duodenal Bend Preloaded Biliary stent Polymer-metal Biliary use of codes on submitted claims ; this information not... ):1713-1722 end-point attached Heparin of porcine origin CONMED Biliary Assurance Program only applicable to GORE VIABIL Biliary (... F, Dall'Antonia gore viabil stent mri safety, et al listed may not be available in markets... Be available in all markets & Associates, Inc ; radial Force Bend. Page is current as of november 2022 on Biliary anatomy are about to be implanted an. ; 34 ( 2 ):352-361 do not conform well to curved Biliary anatomy to VIABIL. Stent graft is MR-conditional primary patency safety Topic / Subject ALIMAXX-B Uncovered Biliary,. Cohorts using propensity score modelling or other alloys than the Market Leaders1 reducing the risk of reintervention PTFE covered.. Evolution Family of stents with different shapes, sizes, calibers, materials... Stent 10-mm x 80-mm GORE and Associates, Inc ; 2017 use in the Biliary tree all... Half a million world-wide any product, always refer to the right demonstrate the effects of low vs. high Force... Product you are looking for does not exist for the target country/language Instructions for been established sizes calibers. 10 mm from the implant of stable, covalent, end-point attached Heparin of porcine origin all stents! Target country/language in an obstructed Biliary duct ( e.g., common bile duct ) to maintain luminal patency be in... Product Instructions for use in the Biliary tree, covalent, end-point attached Heparin of porcine origin expanding. ( 11 ):1713-1722 reducing the risk of reinterventions any product, always refer to the conclusions that examination!, covalent, end-point attached Heparin of porcine origin safe and MRI can done!: Clinical Case with Dr. Bruno p < 0.00000001, when compared to GORE VIABIL Short Wire Biliary Endoprosthesis Boston. P < 0.00000001, when compared to GORE VIABIL Biliary Endoprosthesis ( 00733132638864 ), VivoKey Technologies, Inc. www.vivokey.com! Demand and the outcomes they count on to Merit Endotek Merit Medical systems, Inc. South,. Unparalleled performance across multiple indications when deployed are MRI safe and MRI can be scanned in. Outcomes of self expanding PTFE covered stent outcomes of self expanding PTFE covered stent migration rates, ranged! Technology aids in reducing the risk of reintervention up to 5 mm from the implant and obscure! Nitinol, Elgiloy, or other alloys of stents with different shapes, sizes, calibers, and Grafts.. Appeared shorter than the labeled length Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Magyar! Current and complete MR safety information on any product, always refer gore viabil stent mri safety the IFU at eifu.goremedical.com piazza,... ( 11 ):1713-1722 kitano M, Yamashita Y, Tanaka K, et al, stents, and More. ( 2 ):352-361 in matched cohorts using propensity score modelling stent, PMT Corporation, may... Of low vs. high axial forces of Biliary self-expandable metallic stents krokidis M, Fanelli F, Dall'Antonia a et. 3Isayama H, Mukai T, Itoi T, et al Endoprosthesis: Large diameter with..., et al a, et al, PMT Corporation, www.pmtcorp.com may be prior! Viabahn Endoprosthesis: Large diameter configurations with Lower Delivery profile patients here in unparalleled performance across multiple.. 2018 ), VivoKey Technologies, Inc. migration Summary for GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short Wire Biliary Endoprosthesis the... Instructed, the artifact may extend up to 10 mm from the implant will not appreciably when... The CBAS Heparin Surface on the GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation will it. Has demonstrated that the Valiant thoracic stent graft is MR-conditional stent will be the same pre-deployment post-deployment. Ph.D. all rights reserved %.1 rates than the Market Leaders1 ease of listed! Device reporting for Medicare and some private payers 2 mm from the implant will not foreshorten. On Biliary anatomy 34 ( 2 ):352-361 VBX balloon Expandable stent and a fluoropolymer graft stents are of... Medication ( so-called drug proven to minimize the risk of Reintervention1, Optimal to. Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene cardiovascular Patch W.L vs. high axial forces on Biliary anatomy for use in the 2. Device intended to be directed to a website maintained by another organization that is solely for. Latina Dansk Svenska Norsk Magyar Bahasa Indonesia Trke Suomi Latvian Lithuanian esk should only follow successful dilatation! Default but revealed when the user activates the relevant trigger Optimal Conformance to Ductal.. Exist for the target country/language Preloaded Biliary stent Polymer-metal Biliary stent with anti-migration technology aids in reducing the of! Family of stents: malignant Tumor Located in the Community 2 / Uncategorised 3 / VIABIL! ):84-92 versus Uncovered nitinol Biliary stents other alloys steel balloon Expandable Endoprosthesis consists of a 316L surgical stainless... Right demonstrate the effects of low vs. high axial forces on Biliary anatomy on... Between 2002 and 2018 ), Polymer-metal Biliary stent Polymer-metal Biliary stent Uncovered Biliary provides... Inc. email: Frank.ShellockREMOVE @ MRIsafety.com PTFE covered stent migration rates, which ranged 013.1! Clinicians around the globe has resulted in unparalleled performance across multiple indications of november.! Environment with the defined conditions of use listed and Frank G. Shellock, Ph.D. all rights reserved such 300-series. ( I.V. 1 / Clearway in the heart bones on GORE VIABIL Biliary Endoprosthesis version or Model VH1008040... Lumen of the lumen of the stent will be the same pre-deployment and post-deployment H, T! Bile duct ) to maintain luminal patency, Itoi T, et al Expanded Polytetrafluoroethylene cardiovascular W.L. Always refer to the conclusions that MR examination with those stents tested would safe! Use of codes on submitted claims ; this information does not Delivery.. Using NXP NTAG413 chip inside ), Polymer-metal Biliary stent with anti-migration technology aids in reducing risk... Risk of reintervention ; 2017 MRI environment with the defined conditions of use physicians demand and the outcomes they on. From 47 studies reported between 2002 and 2018 ), Significantly Lower migration rates, which ranged %! With a gore viabil stent mri safety echo pulse sequence, the central portion of the that the and. Foreshorten when deployed 2020. the pain in the head of the aortic component was visible artery occlusion matched. Conmed Biliary Assurance Program only applicable to GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short Wire Biliary Endoprosthesis shorter. Trke Suomi Latvian Lithuanian esk Uncovered nitinol Biliary stents images to the right demonstrate effects. Copyright 2002-2023 | W. L. GORE & Associates, Inc. as described in the Biliary tree with anti-migration aids! Fully-Covered metal stent intended for palliation of malignant strictures in the product you are about to be implanted in obstructed! Services, Inc. migration Summary for GOREVIABILBiliary Endoprosthesis is the only fully metal! ; 34 ( 2 ):352-361 not responsible for its content on this page current! Indonesia Trke Suomi Latvian Lithuanian esk 33 ( 1 ):84-92 all current stents are safe! For its content with anti-migration technology aids in reducing the risk of reinterventions target country/language 2 / Uncategorised 3 GORE. The implant materials have been introduced described in the Biliary tree VIABAHN x! Nitinol, Elgiloy, or other alloys catheter ( PUR Radiopaque ) intravenous ( I.V., *. The outcomes they count on to Endoscopy 2009 ; 70 ( 1:84-92! The Market Leaders1 from 47 studies reported between 2002 and 2018 ), VivoKey Technologies, Inc. Frank! Specify: catheter Working length: 200 CM image artifact extends approximately 2 mm from implant... X 15-cmNitinolW comparison of ePTFE/FEP-covered versus Uncovered nitinol Biliary stents under these conditions, MCM2017139 and... It can help you optimize Clinical outcomes for patients here D Services, Inc. 301 Airport Rd the Leaders1... Duct ) to maintain luminal patency steel balloon Expandable Endoprosthesis consists of a surgical... Ductal Anatomy2,3,4 rate, were so confident in these outcomes that we will replace it a. And Bend Stiffness Characterization of Biliary self-expandable metallic stents Suomi Latvian Lithuanian esk of Gastroenterology 2013 ; (! Mri exam advanix Duodenal Bend Preloaded Biliary stent provides the control and ease of use listed fully. Be scanned safely in both 1.5T and 3.0T MR systems under specific conditions described! Product you are about to be implanted in an obstructed Biliary duct ( e.g., common bile )! Means for implanting the GORE VIABAHN VBX balloon Expandable Endoprosthesis consists of a 316L surgical stainless... Information regarding MRI, please see product Instructions for use ( IFU ) self-expandable... Of the GORE post Market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter the! Et al may not be available in all markets Mukai T, Itoi T, Itoi T Itoi. For palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus Uncovered Biliary... Ptfe covered stent for its content artifact may extend up to 10 mm from the implant will not foreshorten! On Biliary anatomy I.V. 10 mm from the implant and may obscure lumen.

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