gore viabil stent mri safety

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 . 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. Krokidis M, Fanelli F, Orgera G, et al. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VH1008040 Commercial . This panel is hidden by default but revealed when the user activates the relevant trigger. 2022 CONMED Corporation. Unique anti-migration technology aids in reducing the risk of reinterventions. You are about to switch country/language. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. 7 W. L. Gore & Associates, Inc. Reduce the risk of reintervention. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. Krokidis M, Fanelli F, Orgera G, et al. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. 2013 Nov;108(11):1713-22. L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. 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. MPD Customer Care. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. 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. 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. English. Durable Liner Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Currently, different kinds of stents with different shapes, sizes, calibers, and materials have been introduced. Evolution Family of Stents: Malignant Tumor Located in the Head of the . Device Size Text, specify: Catheter Working Length: 200 CM. GORE TAG Conformable Thoracic Stent Graft. Deutsch. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. The GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of a 316L surgical grade stainless steel balloon expandable stent and a fluoropolymer graft. American Journal of Gastroenterology 2013;108(11):1713-1722. AW0010-EN3 Device: GORE VIABIL Biliary Endoprosthesis: Enrollment 43 Participant Flow . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. 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. 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. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. L. Gore and Associates, Inc., www.wlgore.com, GORE TIGRIS Vascular StentAll sizesW.L. [Work plan]. 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. Unique anti-migration technology aids in reducing the risk of reinterventions. Kitano M, Yamashita Y, Tanaka K, et al. Gore and Associates, www.goremedical.com, GORE-TEX Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch W.L. The only fully covered metal stent with anti-migration technology, ENDO_GORE VIABIL Biliary Endoprosthesis Anti-Migration Assurance Program. 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. Flagstaff, AZ; 2012. GMDN Definition. The GOREVIABILBiliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists . Gastrointestinal Endoscopy 2012;76(1):84-92. 1W. L. Gore & Associates, Inc. Migration Summary for GORE VIABIL Biliary Endoprosthesis and BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent. The number of coronary stents may be over half a million world-wide. The patient should not be exposed to a magnetic field. 3. MRI Compatibility: Stent Graft Compatibility: Patient Limitations: CardioMEMS, Inc. . Am J Gastroenterol. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. (Reported data is aggregated from 47 studies reported between 2002 and 2018), Significantly Lower Migration Rates than the Market Leaders1. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. Cardiovascular & Interventional Radiology 2010;33(1):97-106. GORE CARDIOFORM Septal Occluder. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Header Illustration: Keith Kasnot, MA, CMI, FAMI*If deployed as instructed, the endoprosthesis will not appreciably foreshorten. 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 information on this page is current as of November 2022. 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. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . VIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. 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). 15 minutes of scanning (i.e. 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. Gastrointestinal Endoscopy 2009;70(1):37-44. 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. European Journal of Vascular . Gore's Anti-Migration Assurance Program offered through ConMed. Stents are not a magnetic resonance imaging (MRI) contrast medium. To order a product, click here. 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. RX Only. Higher primary patency 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. 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. Allure Vaginal Stent, PMT Corporation, www.pmtcorp.com May be removed prior to MRI and replaced after the MRI exam. Learn about our Anti-Migration Assurance Program. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VSWVN0806 Commercial Distribution Status: In Commercial Distribution Catalog Number: VSWVN0806 Company Name: W. L . Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . [Work plan]. 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. AW0010-EN3. 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