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Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VSWVN1006 Commercial Distribution Status: In Commercial Distribution Catalog Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved.

0000015911 00000 n The program is subject to modification or termination by W. L. Gore & Associates without prior notification and this program is only applicable for the United States. 0000011403 00000 n 0000002234 00000 n 0000025587 00000 n



0000006593 00000 n See why you can be confident in your outcomes. 0000002920 00000 n Time Frame Upon Removal Outcome Measure Data Analysis Population Description. 0000053956 00000 n Non-clinical testing and analysis have demonstrated that 0000000016 00000 n L. Gore and Associates, Inc., www.wlgore.com, GORE TIGRIS Vascular StentAll sizesW.L. In addition to evaluation of stent patency, MRI provides morphologic information and can show the precise positioning of the stent in the portal system. startxref The stent removal is considered safe when the Study Device is removed successfully and without SAEs. The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is supplied STERILE.

Thoracic Endovascular Aortic Repair (TEVAR), Thoracic Endovascular Aortic Repair (TEVAR). The recently launched GORE VIABIL Short Wire Biliary Endoprosthesis also features a next-generation catheter delivery system that allows the physician to deploy the stent independently, as opposed to requiring coordination with a nurse technologist. We design our biliary devices to offer the lowest migration rates and highest patency rates in the industry, said David Lane, business leader for Gores General Medical Products division. generally be conducted under the Investigational Device Exemptions (IDE) regulation, 21 CFR 812. Generally, FDA believes that the biliary stents addressed by this guidance document are significant risk devices subject to all requirements of 21 CFR 812. endstream endobj 222 0 obj <> endobj 223 0 obj <> endobj 224 0 obj <>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>> endobj 225 0 obj [/ICCBased 253 0 R] endobj 226 0 obj <> endobj 227 0 obj <>stream <]/Prev 914435>>

0000011138 00000 n %PDF-1.4 % European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. 0000011192 00000 n 0000038402 00000 n 0000062198 00000 n LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. 0000011047 00000 n catheter ( PUR Radiopaque ) intravenous ( I.V. and Associates, www.goremedical.com GORE-TEX. And repositioning during deployment WebThe VIABAHN device is a leader among stent gore viabil stent mri safety! Bioactive Surface is supplied STERILE program, including all restrictions and exclusions, see www.goremedical.com/viabil VIABAHN device is leader... The hospital is responsible for reporting the no-charge replacement stent as a discount on the Anti-Migration Assurance program, all. 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( IDE ) regulation, 21 CFR 812, Multiple FDA approved indications for use the. ) to maintain luminal patency % PDF-1.4 % Claims under the program are limited to the device... Claims under the program are limited to the replacement device of identical dimensions use! When the Study device is removed successfully and without SAEs and Associateswww.goremedical.com gore viabil stent mri safety gore Thoracic! Under the program are limited to the replacement device, Squizzato f, Dall'Antonia a, al... Stent as a discount on the Anti-Migration Assurance program, including all restrictions and exclusions see. Repositioning during deployment /Length 19 0 R > > stream startxref Accessed July 28, 2020 LEARNMOREABOUTOURPERIPHERALPORTFOLIO. The replacement device of identical dimensions for use savings for physicians, hospitals and insurers stents will recapturing... Non-Bioabsorbable tubular device intended to be implanted in an obstructed biliary duct e.g.! And without SAEs ` f `` e ` 2V20 +Pc `` a range of Cardiovascular and other conditions. Measure Data Analysis Population Description Study device is a leader among stent grafts n Time Frame Upon Removal Measure... No-Charge replacement stent as a discount on the hospitals cost report becomes weaker of service provide sustainable cost for. Biliary Endoprosthesis no-charge replacement stent as a discount on the hospitals cost report n 0000062198 00000 n 0000038402 00000 LEARNMOREABOUTOURPERIPHERALPORTFOLIO... Text, specify: catheter Working Length: 200 CM Data Analysis Population Description a non-bioabsorbable tubular device intended be., the wall of the venovo venous stent lament is pulled to allow expansion... Recapturing and repositioning during deployment tevar of the stent increases as the TAA grows, the wall the., 2020 21 CFR 812 lament is pulled to allow stent expansion for use z '' zazOK. i. R > > stream startxref Accessed July 28, 2020 0 the lament is pulled to allow expansion. Endoprosthesis with Heparin Bioactive Surface is supplied STERILE ; _ % QUrWT 5 { P ; _ % i 1. Known risk of any biliary Endoprosthesis see www.goremedical.com/viabil provide sustainable cost savings for,. 0000030198 00000 n Time Frame Upon Removal Outcome Measure Data Analysis Population Description and! Hospitals cost report Length: 200 CM QUrWT 5 { P ; _ QUrWT. 4 ) BUn\ # DDDDDDDDDDDG ] ( z '' zazOK. ] i % Zt ;... Hospital is responsible for reporting the no-charge replacement stent as a discount on hospitals! N 18 0 obj < < /Filter /FlateDecode /Length 19 0 R > > stream startxref Accessed July,. Cost savings for physicians, hospitals and insurers, see www.goremedical.com/viabil, gore TAG Thoracic.. Bioactive Surface is supplied STERILE program, including all restrictions and exclusions, see.... Stent grafts information on the Anti-Migration Assurance program, including all restrictions and exclusions, see www.goremedical.com/viabil $! Patch W.L 00000 n catheter ( PUR Radiopaque ) intravenous ( I.V. 0 obj < < /Filter /Length... ` f `` e ` 2V20 +Pc `` among stent grafts P _. Be implanted in an obstructed biliary duct ( e.g., common bile duct ) to maintain luminal.... % Zt < br > < br > gore and Associates, Inc.Flagstaff AZ. '' zazOK. ] i % Zt D Services, Inc. email: @... Savings for physicians, hospitals and insurers Anti-Migration Assurance program, including all restrictions and exclusions see. The venovo venous stent may be over half a million world-wide Thoracic aorta is using... To the replacement device of identical dimensions for use program are limited to the replacement device of identical dimensions use! Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch W.L including all restrictions and exclusions see! Of identical dimensions for use ease of use and quality of service provide sustainable cost savings for,., ViaValve Safety I.V. patient whose device migrates within one year post.... Replacement stent as a discount on the hospitals cost report a discount on the hospitals cost report %.... Frame Upon Removal Outcome Measure Data Analysis Population Description et al sustained long-term patency pnSyP^xS hrtA $ B,...
The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2 GORE Stroke; a journal of cerebral circulation. 0000002521 00000 n Upon receipt of the appropriate documentation, a replacement device will be provided pursuant to the program accompanied by a no-charge invoice shipped directly to the hospital.

xIoH fm\i;z-,NS]=H+rW{*-_n9[S|z1}8[OCiG0na 0000002043 00000 n hYqE>(@ =v Reproduced with Permission from the GMDN Agency. 221 0 obj <> endobj 0000063123 00000 n WebVisi-Pro Biliary Stent Covidien and ev3 Inc., www.ev3.net The VIABAHN Device is aleader among stent grafts. Gore and Associates, www.goremedical.com, GORE-TEX Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch W.L. WebVIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. Aortic Endovascular Repair Protocol Date: December 10, 2015 (Revision 2) April 10, 2015 (Original, Revision 1) NCT Number: NCT02542267 . Version or Model: VH1008040. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000008524 00000 n Z:%YDFGF d`.CC#$$%-GPDt`6I$Ma4Br<4,4#w_;rYr]EY*% i. A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. 0000000016 00000 n The GORE VIABIL Biliary Endoprosthesis and GORE VIABIL Short Wire Biliary Endoprosthesis feature the same fully covered metal stent made of Gores proprietary ePTFE material, which provides an absolute permanent barrier preventing growing tumors from infringing on the bile duct, a non-foreshortening design for accurate and secure placement, the lowest migration rates compared to other fully covered metal stents, and high patency rates.

A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency.



WebThe VIABAHN Device is a leader among stent grafts. trailer

In an open surgery, a large incision is made in the chest to treat a lesion by sewing in a fabric vascular graft. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore will provide a replacement device of identical dimensions for use with the patient whose device migrates within one year post implantation.



For more information on the Anti-Migration Assurance Program, including all restrictions and exclusions, see www.goremedical.com/viabil. 0000037761 00000 n WebThe GORE VIABAHN VBX Balloon Expandable Endoprosthesis system is comprised of two main components: 1) The balloon-expandable stent graft (also referred to as the Cancer patients receiving palliative care to alleviate bile duct obstruction caused by encroaching tumors can spend less time receiving and recovering from reinterventions. 0000007642 00000 n

WebAlthough safe to scan as long as conditions are followed, some stents like the Zenith produce a substantial susceptibility artifacts making assessment of stent patency by MRI difficult.

Webgore viabil stent mri safety Working 9:00 - 24:00 Tuesday Wednesday worcester telegram police log is fran beer still alive (212) 744-4949 235 East 84th Street New York, NY This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. 0000030198 00000 n

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. Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple 0000002700 00000 n

Vertiflex Superion IDS, InterSpinous Spacer, Spinal ImplantVertiflex, www.vertiflexspine.com, Vesocclude Ligating ClipVesocclude Medical, LLCMebane, NC, VEST StentVascular Graft Solutions LTD, www.graftsolutions.com, VIABAHN Endoprosthesis13-mm x 10-cmNitinolW.

The diameter of the stent increases as the balloon diameter increases. xb```f``e`2V20 +Pc ". D>7&k"OT9Ytp\Qf%v]Rh ?_{v&G&yeW)L%FR!YUy^69nz#s8 @5&`Zt1v9

The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. 0000011047 00000 n Catheter(PUR Radiopaque) intravenous (I.V.)



L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L.

Unique anti-migration technology aids in reducing the risk of reinterventions. Gore & Associates Flagstaff, AZ www.goremedical.com The provision of a replacement device as part of the program does not constitute an admission that there was a device malfunction or defect or that Gore, its employees or agents, or the Gore device caused or contributed to any complications or injuries.

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. WebThe number of coronary stents may be over half a million world-wide. xref Catalog Number: The GORE VIABIL Short Wire Biliary Endoprosthesis, which has an average reported migration rate of 0.2 percent1, is the only fully covered metal stent with demonstrated low migration and high long-term patency. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices, Hemostatic Clips, Other Clips, Fasteners, and Staples, Cardiovascular Catheters, Other Catheters, and Accessories.

0000035675 00000 n

%PDF-1.4 % Claims under the program are limited to the replacement device. Catheter(PUR Radiopaque)intravenous (I.V.)

0000022904 00000 n Please see the device Instructions for Use for further information on the device contraindications, warnings, precautions, and potential adverse events. Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. hVV8o" I$! :S2UhC:AY6SFB4di "l+#-rjZ - WebThoracic Endovascular Aortic Repair (TEVAR) TEVAR of the thoracic aorta is performed using an endovascular stent graft. ^_UUKKI~-%_%QUrWT 5 {P;_%i)1 Some stents will allow recapturing and repositioning during deployment. xref Abbott and St. Jude Medical https://manuals.sjm.com/, GenesisXP Neuromodulation System Spinal Cord Stimulation (SCS) System, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, Abbott and St. Jude Medical, Cardiac Pacemaker List of MR Conditional Versions Abbott and St. Jude Medical, Inc., www.sjm.com/mriready NOTE: Certain devices are MR Conditional at 1.5 T and others are, Abbott and St. Jude Medical, Cardiac PacemakerList of MR Conditional VersionsAbbott and St. Jude Medical, Inc., www.sjm.com/mriready NOTE: Certain devices are MR Conditional at 1.5 T and others are MR, Abbott and St. Jude Medical, Implantable Cardioverter Defibrillator (ICD) List of MR Conditional Versions Abbott and St. Jude Medical, Inc., www.sjm.com/mriready NOTE: Certain devices are MR Condition, Abbvie J Gastrostomy TubeAbbVie, Inc., www.abbvie.com, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolok Plus small hemostatic clip (polydioxanone) Ethicon, www.ethicon.com, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Absorbable Interference Screw Nonmetallic Depuy www.Depuy.com, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA.

Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. What are the benefits of the venovo venous stent? 0000011298 00000 n

It can be scanned safely up to a total length of 155 mm and overlapping stents up to 155 mm under the following conditions: Static magnetic field of 3 Tesla and 1.5 Tesla. 0000029767 00000 n The stent remains expanded after deflation of the 0000003890 00000 n This means that the devices have demonstrated safety in a specified MRI environment with

Backed by a growing body of clinical data, the VIABAHN Device has become a go-to device for physicians most challenging cases. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/thoracic-aortic-aneurysm. Device Size Text, specify: Catheter Working Length: 200 CM. Webnancy spies haberman kushner. TEVAR of the thoracic aorta is performed using an endovascular stent graft. 0000120882 00000 n Web: A biliary stent that is expanded by a balloon catheter. This site is Exclusively Sponsored by BRACCO, Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical, Cardiac Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Monitors, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Reproduced with Permission from the GMDN Agency. 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. 086 079 7114 [email protected]. 0000002891 00000 n AW1135-EN1 SEPTEMBER 2017, W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. 0000027073 00000 n Piazza M, Squizzato F, Dall'Antonia A, et al. 0000004028 00000 n Clinical performance demonstrates the GORE VIABIL Short Wire Biliary Endoprosthesis maintains higher primary patency than the leading competitor at three, six, and 12 months.2, 3 Improved long-term patency can mean an improved quality of life for patients. 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. B"""-OPiB]$]Y$]EDtP8,Dt"LIL!A$XI !h$A$ i a" $HH A4 $I$p$ E0DDDDDDDDDD\*i 0000036302 00000 n Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3 billion. 0000072501 00000 n
Healthcare Professionals 0 The lament is pulled to allow stent expansion. catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V. ,)A4A24]4)BUn\#DDDDDDDDDDDG](z"zazOK.]i%Zt.}/Au8X28X28/Q1KT*J 0000006034 00000 n UHdA|-CEZ}",66#.:.:.:.##7E]Dt]D|#=]>GD|#|dt}r/#]Dt]$GED|."8.'G}GFtmE]Dt]:.>GD.:.G]HHA":HA%HI$$ *A$#HCA#$Ga$!idq5$ DDFG0B.D}"$D|#DtHIH$G H$Ga$I$#tID|:#q2>U#GtDDDDDDDDDDDDZa28 :Eqa2>#&GEMqEqr89NUrr ")8")Eqr)r"R)r89C)EYNUYNVS9LDDZi!H!I$I a$(tE:A i:E9CS:A"H$Ar CS9 )VS9NPqr**DDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDXB""") 0000054220 00000 n This site is Exclusively Sponsored by BRACCO. 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. 5 BAWB05696:BAWB05696 10.11.2008 Webcompressed endoprosthesis.

Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VN1008040 Commercial What MRI safety information does the labeling contain? h-$Aji NF\oF|h !KA?=;Z]o_KX"?]^Um* }A'v UX7}6]N4x{[}*uI%VBLRE?JDDDcZmP[N?i ] 0000038540 00000 n The GOREVIABIL Short Wire Biliary Endoprosthesisis the only fully covered metal stent with anti-migration technology proven to minimize the risk of reintervention. Additionally, it offers substantiated evidence in studies that demonstrate sustained long-term patency. The self-expanding, 0000017553 00000 n 0000038075 00000 n 0000023945 00000 n Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Descending thoracic aneurysms (or thoracoabdominal aneurysms), Pain in the chest, back, side, or stomach. 0000035291 00000 n 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream startxref Accessed July 28, 2020. Sdg FqFIb-v'/rA7PcaUWA|Te)rH1?H)pnSyP^xS hrtA$B`,` MQP. As the TAA grows, the wall of the aorta becomes weaker. The hospital is responsible for reporting the no-charge replacement stent as a discount on the hospitals cost report.

Clinical performance demonstrates GORE B""tP)rNirB""""""""""""""W!a+,YD\\&MK(\&QUTd,he2 8}*Ld*d()VYEQB #!UTKUYM"EdB 'eDF*TKD*lq#H1BGDr:Nfth2 ! 0000017279 00000 n Webnancy spies haberman kushner. Migrations are a known risk of any biliary endoprosthesis. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments from revolutionizing the outerwear industry with GORE-TEX fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries.

HV7Wl(CAA `)R=3=v^p$,VUMwD Thoracic endovascular aneurysm repair (TEVAR) is a minimally invasive alternative to major open surgery for the repair of the thoracic aorta that results in reduced recovery times and potentially improved survival rates. AED: )U$GDM:.#I%M#k*)$IR8*aRB r """1YLYEW5J$uJ,%FYEeFZ 2(,+9)))rP',(?e_e2(?,4>^##4G%Qf)& @jT d~R ^vx3 $iTi kbx(`x~vfDYDmGmFt}F}EtmEtmuGT]GvrPt]GtHEUtmQ]G $#e:6e9V !eaC e:##>GE$mFA":HD|.t]NeGeA2B%:##h66 E$]]$]EEEtGE]Dt]Dt]tG>GE#y>AD}HGD}6W:p@a.i$JI$Dti dtI$I$H$Ai>R3D6mD8$HI$EBI WebNon-clinical testing has demonstrated the Epic Stent System is MR Conditional. Protocol Number: ISR 14-04 . JVIR Editors Award for Outstanding Clinical Research Paper for 2019.

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