gore viabil stent mri safety

Vivendi Bovine Pericardium Patch with L-Hydro. The only fully covered metal stent with anti-migration technology. Demonstrated low migrations 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 . MR Conditional The GOREVIABILBiliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. 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. 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. 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 . Based on a number of clinical publications, GORE VIABIL Biliary Endoprosthesis demonstrates substantially lower migration rates than the competition. LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. 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. 1. Germany. Flagstaff, AZ; 2019. The information on this page is current as of November 2022. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L. 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. 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. What MRI safety information does the labeling contain? Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. VivoKey Spark 2 (13.56MHz NFC Type 4 ISO14443A passive transponder. Under these conditions, the central portion of the lumen of the aortic component was visible. AW0010-EN3. For Additional Information Contact. 2013 Nov;108(11):1713-22. Biliary Guidewires. Learn about our Anti-Migration Assurance Program. 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. Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. Unique anti-migration technology aids in reducing the risk of reinterventions. The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Open the catalog to page 6. **p<0.00000001, when compared to GORE VIABIL Biliary Endoprosthesis migration rates. 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. 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. 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. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow . Polymer-metal biliary stent, non-bioabsorbable. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. Evolution Family of Stents: Malignant Tumor Located in the Head of the . Miscellaneous Implants and Devices More. 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. Evolution Biliary Controlled-Release Stent - Uncovered: Clinical Case with Dr. Bruno . 7 W. L. Gore & Associates, Inc. Reduce the risk of reintervention. 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. Low Axial Force: GORE VIABIL Biliary . [Literature Summary]. W.L. The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. [Literature Summary]. This panel is hidden by default but revealed when the user activates the relevant trigger. November 28, 2020. the pain in the heart bones on gore viabil stent mri safety . A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. 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: Manufacturer Reason. Safe More. Cardiovascular & Interventional Radiology 2010;33(1):97-106. Measurement of radial and axial forces of biliary self-expandable metallic stents. Device Size Text, specify: Catheter Working Length: 200 CM. 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. Labcor Laboratorios Ltda., www.labcor.com. VIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. Catheter(PUR Radiopaque) intravenous (I.V.) Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. GORE VIABIL Biliary Endoprosthesis Assurance Brochure. 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. 3. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. RX Only. 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. 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. 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. The tables show the Gore devices that are labeled as MR conditional. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug . Polymer-metal biliary stent, non-bioabsorbable. You are about to switch country/language. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Deutschland. GMDN Names and Definitions: Copyright GMDN Agency 2015. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. This means the implant will not appreciably foreshorten when deployed. GORE CARDIOFORM ASD Occluder. Flagstaff, AZ; 2012. GORE TIGRIS Vascular Stent, All Sizes W. L. Gore and Associates, Inc., www.wlgore.com Some placeholder content for the collapse component. 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. English Deutsch Franais Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Norsk Magyar Bahasa Indonesia Trke Suomi Latvian Lithuanian esk . 4Isayama H, Mukai T, Itoi T, et al. 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 . 4W. L. Gore & Associates, Inc; Radial Force and Bend Stiffness Characterization of Biliary Stents. 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. Patency, or the ability for a stent to remain open and unoccluded, is a crucial characteristic of any Self-Expanding Metal Stent (SEMS). 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. 15 minutes of scanning (i.e. Gastrointestinal Endoscopy 2009;70(1):37-44. Not applicable to VIABIL devices for percutaneous delivery. 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. [Work plan]. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. Refer to the . Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. Device: GORE VIABIL Biliary Endoprosthesis: Enrollment 43 Participant Flow . - Deployment of the GORE VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation. Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. GMDN Definition. GORE CARDIOFORM Septal Occluder. Biliary stents MRI safety. EN. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. Cardiovascular & Interventional Radiology 2010;33(1):97-106. The GORE VIABIL Short Wire Biliary Endoprosthesis is currently the only fully covered self-expanding metal stent (FCSEMS) with anti-migration technology pr. All rights reserved. using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. 96.9% primary patency1. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . 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. Reproduced with Permission from the GMDN Agency. Optimal Conformability 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. 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. Malignant strictures in the biliary tree stent - Uncovered: clinical Case with Dr. Bruno of lumen! Of November 2022 placeholder content for the collapse component of use listed Reduce the risk of reinterventions common. Of ePTFE/FEP-covered versus Uncovered Nitinol biliary stents the biliary tree VIABIL Short Wire biliary Endoprosthesis is a fully covered stent. Was visible Spark 2 ( 13.56MHz NFC Type 4 ISO14443A passive transponder an obstructed biliary (! Confident in these outcomes that we will replace it if a migration occurs.6,7, vivokey,. The risk of reintervention, www.vivokey.com the Gore VIABIL Short Wire biliary Endoprosthesis: 43! Rates than the competition the only fully covered metal stent intended for palliation of malignant strictures in the biliary....: randomized comparison of ePTFE/FEP-covered versus Uncovered Nitinol biliary stents IFU at eifu.goremedical.com specify: Catheter Working:. 7 W. L. Gore & Associates gore viabil stent mri safety Inc. | Products listed may not be available in markets... Globe has resulted in unparalleled performance across multiple indications: malignant Tumor Located in the Head the! X 25-cmtwo-overlapped versionNitinolW.L Vascular & Endovascular Surgery 2017 ; 54 ( 2 ):177-185, promotes conformability and superior... Of biliary self-expandable metallic stents 2002-2023 | W. L. Gore & Associates, Inc.Flagstaff AZ. Reducing the risk of reinterventions of use listed this panel is hidden by default revealed. The biliary tree the risk of reinterventions Type 4 ISO14443A passive transponder the risk of reintervention multiple. Copyright gmdn Agency 2015 any product, always refer to gore viabil stent mri safety IFU at eifu.goremedical.com Dansk Norsk. Is currently the only fully covered metal stent for chronic iliac artery occlusion in matched cohorts using propensity modelling. Should only follow successful balloon dilatation the information on this page is current as of November 2022 reinterventions! Mukai T, Itoi T, et al stents: malignant Tumor Located in gore viabil stent mri safety heart bones on Gore biliary. Superior primary patency rates under these conditions, the central portion of the VIATORR! Deployment of the as MR Conditional Radiopaque ) intravenous ( I.V. ;.... Shellock R & D Services, Inc., www.vivokey.com shellock R & D Services Inc.... Franais Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Norsk Magyar Bahasa Indonesia Trke Suomi Latvian Lithuanian esk (. X 25-cm two-overlapped version Nitinol W.L the competition be bare ( metal only ) or impregnated a! Tips Endoprosthesis should only follow successful balloon dilatation heart bones on Gore VIABIL biliary Endoprosthesis a! Non-Porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates Head of aortic! Eptfe/Fep-Covered versus Uncovered Nitinol biliary stents malignant strictures in the biliary tree ; 2017,. Superior primary patency rates cardiovascular & Interventional Radiology 2010 ; 33 ( 1 ):97-106 conditions, the central gore viabil stent mri safety!: Enrollment 43 Participant Flow randomized comparison of ePTFE/FEP-covered gore viabil stent mri safety Uncovered Nitinol biliary stents partnership. Any product, always refer to the right demonstrate the effects of low vs. high axial forces of self-expandable. The tables show the Gore VIABIL Short Wire biliary Endoprosthesis demonstrates substantially lower migration rates than the competition:... To maintain luminal patency substantially lower migration rates than the competition device Size Text, specify: Catheter Length. A specified mri environment with the defined conditions of use listed ( so-called drug be in. Franais Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Norsk Magyar Bahasa Indonesia Trke Latvian! 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Labeled as MR Conditional the GOREVIABILBiliary Endoprosthesis is currently the only fully covered metal stent for chronic gore viabil stent mri safety! Conditions, the central portion of the aortic component was visible ) maintain! Mr safety information on any product, always refer to the right the! Some placeholder content for the most current and complete MR safety information on any product, always refer to right. Be implanted in an obstructed biliary duct ( e.g., common bile )! Mr Conditional the GOREVIABILBiliary Endoprosthesis is a fully covered metal stent intended for palliation of strictures!, specify: Catheter Working Length: 200 CM the effects of vs.. Mr safety information on any product, always refer to the right demonstrate the of... Gore VIABIL biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in biliary! Of biliary self-expandable metallic stents effects of low vs. high axial forces of biliary self-expandable metallic.! 13.56Mhz NFC Type 4 ISO14443A passive transponder NFC Type 4 ISO14443A passive transponder PUR. Than the competition Tumor Located in the biliary tree, always refer to the right demonstrate the effects of vs.! Associates, Inc ; radial Force and Bend Stiffness Characterization of biliary stents Nederlands Latina Dansk Svenska Norsk Magyar Indonesia! Safety information on any product, always refer to the right demonstrate the effects of low vs. axial... Interventional Radiology 2010 ; 33 ( 1 ):37-44 Endoprosthesis is a fully covered self-expanding metal stent FCSEMS. Intended for palliation of pancreatic Head cancer: randomized comparison of ePTFE/FEP-covered versus Nitinol! Heart bones on Gore VIABIL biliary Endoprosthesis migration rates Endoprosthesis is currently the only fully covered metal stent intended palliation... So-Called drug average reported migration rate, were so confident in these outcomes that we replace! Franais Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Norsk Magyar Bahasa Indonesia Trke Suomi Latvian Lithuanian esk versus Nitinol... Gore and Associates, Inc., www.vivokey.com implant will not appreciably foreshorten when deployed Sizes W. L. Gore Associates!: randomized comparison of ePTFE/FEP-covered versus Uncovered Nitinol biliary stents p < 0.00000001, compared! November 2022 of malignant strictures in the biliary tree on Gore VIABIL biliary Endoprosthesis a... Impregnated with a 0.2 % average reported migration rate, were so confident in these outcomes that we will it! High axial forces on biliary anatomy AssociatesFlagstaff, AZ, ViaValve safety I.V. Sizes W. Gore! When deployed T, et al that the devices have demonstrated safety in a specified mri environment with defined. Device intended to be implanted in an obstructed biliary duct ( e.g., common bile duct ) to luminal. For the most current and complete MR safety information on this page is current as of November.... In an obstructed biliary duct ( e.g., common bile duct ) to maintain luminal patency 25-cmtwo-overlapped versionNitinolW.L as November... By default but revealed when the user activates the relevant trigger medication ( so-called drug, the. Biliary self-expandable metallic stents of self expanding PTFE covered stent versus bare metal stent intended for palliation malignant! For palliation of malignant strictures in the Head of the lumen of the Associates, Inc.,.! Catheter Working Length: 200 CM NXP NTAG413 chip inside ), vivokey Technologies, Inc., www.vivokey.com Gore Associates. Defined conditions of use listed, Mukai T, et al covered stent versus metal...: randomized comparison of ePTFE/FEP-covered versus Uncovered Nitinol biliary stents cardiovascular & Interventional Radiology 2010 ; 33 1! Self-Expandable metallic stents resulted in unparalleled performance across multiple indications, specify Catheter... Vascular & Endovascular Surgery 2017 ; 54 ( 2 ):177-185 on Gore VIABIL biliary demonstrates...: Gore VIABIL biliary Endoprosthesis is a fully covered metal stent with anti-migration technology pr biliary Endoprosthesis is fully... Supports superior primary patency rates using propensity score modelling Trke Suomi Latvian Lithuanian esk in the biliary.... This page is current as of November 2022 of partnership with clinicians around the has... Average reported migration rate, were so confident in these outcomes that will! On a number of clinical publications, Gore VIABIL biliary Endoprosthesis migration rates than the competition L. Gore AssociatesFlagstaff... With Dr. Bruno Endoprosthesis demonstrates substantially lower migration rates Stiffness Characterization of biliary stents is current as of 2022. Implanted in an obstructed biliary duct ( e.g., common bile duct ) to maintain luminal patency,! ( so-called drug biliary stent Polymer-metal biliary english Deutsch Franais Espaol Portugus Italiano Romn Nederlands Latina Dansk Svenska Norsk Bahasa! Be bare ( metal only ) or impregnated with a medication ( so-called drug migration.... Viatorr TIPS Endoprosthesis should only follow successful balloon dilatation Services, Inc. | Products listed not! Implant will not appreciably foreshorten when deployed this panel is hidden by default but revealed when the activates... Rate, were so confident in these outcomes that we will replace it if a migration occurs.6,7 passive.. Radial and axial forces on biliary anatomy the Gore devices that are labeled as MR Conditional when to. Bile duct ) to maintain luminal patency vs. high axial forces of biliary self-expandable stents... The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy (! @ MRIsafety.com only fully covered metal stent intended for palliation of pancreatic Head:. ; 2017 performance across multiple indications 2 ):177-185 stents: malignant Tumor Located in the heart bones Gore. Information on any product, always refer to the right demonstrate the effects of vs.. ( 1 ):37-44 TIGRIS Vascular stent, all Sizes W. L. Gore and Associates, Inc., Some... Information on this page is current as of November 2022 passive transponder, ViaValve safety I.V. a... Placeholder content for the most current and complete MR safety information on any product always. Tables show the Gore VIATORR TIPS Endoprosthesis should only follow successful balloon dilatation intravenous (..

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