Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. 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). 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. What MRI safety information does the labeling contain? catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Am J Gastroenterol. Optimal Conformability 800-528-8763. 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 . L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L. 5Isayama H, Nakai Y, Toyokawa Y, et al. 29-32 Studies of peripherally . Refer to the Instructions for Use for additional information. This means the implant will not appreciably foreshorten when deployed. Gastrointestinal Endoscopy 2009;70(1):37-44. The GORE VIABAHN Endoprosthesis is a leader among stent grafts. This site is Exclusively Sponsored by BRACCO. Proven to Minimize the Risk of Reintervention1, Optimal Conformance to Ductal Anatomy2,3,4. The only fully covered metal stent with anti-migration technology. Gastrointestinal Endoscopy 2009;70(1):37-44. The GORE VIABIL Biliary Endoprosthesis offers the optimal balance of low Axial force (Af) and moderate Radial force (Rf), allowing natural conformance of the stent to the bile duct anatomy while maintaining industry-leading primary patency rates. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents. GORE CARDIOFORM Septal Occluder. Coils, Filters, Stents, and Grafts More. 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. 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. In 1 study, ex vivo testing at 1.5 T on 19 different coronary stents revealed 2 to be nonferromagnetic and the remaining 17 to be at worst "minimally" ferromagnetic. 3Isayama H, Mukai T, Itoi T, et al. This outperforms BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent migration rates, which ranged 013%.1. Advanix Biliary Stents; United Kingdom. Polymer-metal biliary stent, non-bioabsorbable. 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. Open the catalog to page 6. WALLSTENT Endoprosthesis. 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. Vivendi Bovine Pericardium Patch with L-Hydro. VivoKey Spark 2 (13.56MHz NFC Type 4 ISO14443A passive transponder. The CBAS Heparin Surface on the GORE VIABAHN VBX Balloon Expandable Endoprosthesis consists of stable, covalent, end-point attached heparin of porcine origin. 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 & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis9-mm x 15-cmNitinolW. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this information does not . GORE TIGRIS Vascular Stent, All Sizes W. L. Gore and Associates, Inc., www.wlgore.com 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. You are about to be directed to a website maintained by another organization that is solely responsible for its content. American Journal of Gastroenterology 2013;108(11):1713-1722. per pulse sequence). The GOREVIABILShort Wire Biliary Endoprosthesisis a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VH1008040 Commercial . Polymer-metal biliary stent, non-bioabsorbable. GMDN Names and Definitions: Copyright GMDN Agency 2015. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Low Axial Force: GORE VIABIL Biliary . GORE CARDIOFORM ASD Occluder. The patient should not be exposed to a magnetic field. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. GORE TAG . Physicians can trust that the length and position of the stent will be the same pre-deployment and post-deployment. W.L. 7 W. L. Gore & Associates, Inc. Reduce the risk of reintervention. Advanix Duodenal Bend Preloaded Biliary Stent with NaviFlex RX Delivery System - 10Fr x 9cm . For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. 2022 MRI Textbook. Safe Mobility; Skin Health; Cardiac and Peripheral Fluid Management; Clinical Nutrition; Emergency Medical Services; Foot and Ankle Surgery ; . Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. Cardiovascular & Interventional Radiology 2011;34(2):352-361. GORE VIABIL Biliary Endoprosthesis (00733132638864), Polymer-metal biliary stent, non-bioabsorbable. This panel is hidden by default but revealed when the user activates the relevant trigger. You are about to switch country/language. 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. Unique anti-migration technology aids in reducing the risk of reinterventions. 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: 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. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. You are about to switch country/language. Deutsch. gore viabil stent mri safety 21st May 2022 . 96.9% primary patency1. Shellock R & D Services, Inc. email: [email protected]. 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. 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. Kitano M, Yamashita Y, Tanaka K, et al. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . High Axial Force: SEMS with high Af do not conform well to curved biliary anatomy. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. Kitano M, Yamashita Y, Tanaka K, et al. 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 . For Additional Information Contact. Currently, different kinds of stents with different shapes, sizes, calibers, and materials have been introduced. Shellock R & D Services, Inc. email: [email protected]. The GORE VIABIL Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. W. L. Gore & Associates, Inc. Migration Summary for GOREVIABILBiliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. 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: A durable, non-porous FEP/ePTFE liner prevents tissue ingrowth, promotes conformability and supports superior primary patency rates. The presence of this implant may produce an image artifact. 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. * Do not attempt to re-capture or re-sheath the GORE VIATORR TIPS Manufacturer Reason. 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. Backed by a growing body of clinical data, the VIABAHN Device has become a go-to device for physicians most challenging cases. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. The images to the right demonstrate the effects of low vs. high axial forces on biliary anatomy. 1W. L. Gore & Associates, Inc. Migration Summary for GORE VIABIL Biliary Endoprosthesis and BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent. 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. 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. 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. 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 . Elkton MD 21921-4130. Gore and Associates, www.goremedical.com, GORE-TEX Regenerative MembraneW.L. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. VIABAHN Endoprosthesis8-mm x 25-cmsingle versionNitinolW.L. This panel is hidden by default but revealed when the user activates the relevant trigger. Unique anti-migration technology aids in reducing the risk of reinterventions. 1. 5Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A. Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. 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 & Associates, Inc.Flagstaff, AZ www.goremedical.com, Viadurleoprolide acetate implantBayer Healtcare PharmaceuticalsWest Haven, CT, Viadurleuprolide acetate implantTitaniumBayer HealthCare PharmaceuticalsWest Haven, CT, VIATORR EndoprosthesisStentNitinolW.L. Safe More. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. 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. To order a product, click here. Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. The information on this page is current as of November 2022. Deutschland. Cardiovascular & Interventional Radiology 2010;33(1):97-106. 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. 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. The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. Catheter(PUR Radiopaque) intravenous (I.V.) This increases the risk of stent migration, ductal kinking, sludge formation, and/or cholangitis.3, Malignant biliary stricture migration rate comparison1 Evolution Family of Stents: Malignant Tumor Located in the Head of the . using NXP NTAG413 chip inside), VivoKey Technologies, Inc., www.vivokey.com. Artifacts extended both inside and outside the device lumen. 1W. L. Gore & Associates, Inc; Biliary Fully Covered Metal Stents Systematic Review of the Clinical Literature. You are about to be directed to a website maintained by another organization that is solely responsible for its content. 6Kitano M, Yamashita Y, Tanaka K, et al. Gastrointestinal Endoscopy 2012;76(1):84-92. 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. Measurement of radial and axial forces of biliary self-expandable metallic stents. Header Illustration: Keith Kasnot, MA, CMI, FAMI*If deployed as instructed, the endoprosthesis will not appreciably foreshorten. 15 minutes of scanning (i.e. Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary stent Polymer-metal biliary . 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. 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. Proven to Minimize the Risk of Reintervention, Higher Primary Patency Rates Than the Competition, Biliary Endoprosthesis Anti-Migration Assurance Flyer. Coils, Filters, Stents, and Grafts More. English. Krokidis M, Fanelli F, Orgera G, et al. MRI Compatibility: Stent Graft Compatibility: Patient Limitations: CardioMEMS, Inc. . Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L. [Literature Summary]. The only fully covered metal stent with anti-migration technology, ENDO_GORE VIABIL Biliary Endoprosthesis Anti-Migration Assurance Program. 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. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. The number of coronary stents may be over half a million world-wide. 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 . American Journal of Gastroenterology 2013;108(11):1713-1722. * In addition, the GORE VIABIL Biliary Endoprosthesis remains in the same location throughout deployment, eliminating the need to use a push-pull technique.
