gore viabil stent mri safety

0000036302 00000 n AW1135-EN1 SEPTEMBER 2017, W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Update my browser now.

The thoracic stent graft is placed within the aneurysm to relieve pressure on the damaged vessel wall by enabling blood flow to bypass the aneurysm. DO NOTremove the Safety Clip (K) until you are ready to deploy the stent. Nominal Endoprosthesis Diameter (mm) Length (cm) Working Lengths of Delivery 0000003890 00000 n Thoracic Aortic Aneurysm. W. L. Gore & Associates, Inc. (Gore) announced the acquisition of InnAVasc Medical, Inc., a privately held medical technology company focused on advancing care for patients with end stage renal disease who utilize graft circuits for dialysis treatment. 221 48 WebBrand Name: GORE VIABIL Biliary Endoprosthesis. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/thoracic-aortic-aneurysm. Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. WebThe use of an expanded polytetrafluoroethylene (ePTFE)-covered Viatorr stent-graft (W. L. Gore & Associates) for TIPS creation has been shown to improve patency rates . 0000011227 00000 n 0000004887 00000 n 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. 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. 0000016859 00000 n WebThe only fully covered metal stent with anti-migration technology The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of 0000035291 00000 n An aneurysm rupture needs immediate medical attention because it can lead to death. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. 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, Reproduced with Permission from the GMDN Agency. WebThoracic Endovascular Aortic Repair (TEVAR) TEVAR of the thoracic aorta is performed using an endovascular stent graft. 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. 086 079 7114 [email protected]. +cEHUE FD|"a&G #a $B 9NQTv&"") g(!F":;Pu#QDLhBGGei\F"aRhei$J;-@E[It With an updated browser, you will have a better Medtronic website experience. GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000002043 00000 n Web Safety and effectiveness in children under the age of 18 has not been established. ?DkG=MC[t}_zM~|~__o4Az_;{_>;oo!{k5aW~l2ZW8%o{o?o%}]]^}_|_d Bz40|V~i^K.kp0@)r !54`IDDDDDD{D|!6.>GEtGd|28 Q]D|#>GG`I..:.dp>#,6( !LsC\Z@sJ Additionally, the device features low axial force, the recovery force that leads to straightening after being bent, and moderate radial force, which maintains and extends the luminal patency at the stricture once deployed. 5 BAWB05696:BAWB05696 10.11.2008 Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.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. Just prior to deploying the stent, the Safety Clip (K) must be removed by pressing the two red tabs(L) together and removing the clip from the grip. FIGURE 1A: GORE VIABAHN ENDOPROSTHESIS 5-8 MM DEVICES External Nitinol Stent ePTFE Lining Full Anti-Migration Assurance Program Details: Directions for Use supplied with all accessories used in conjunction with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface. Once deployment is started, repositioning the endoprosthesis should not be attempted. Do not dilate the endoprosthesis with a balloon longer than the labeled endoprosthesis length (Table 1). 0000000016 00000 n The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. Unique anti-migration technology aids in reducing the risk of reinterventions. Learn about our Anti-Migration Assurance Program The lament is pulled to allow stent expansion. Unsafe 1 More Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical More Neuroform Atlas Stent.

GORE, GORE-TEX, and VIABIL and designs are trademarks of W. L. Gore & Associates. 0000063123 00000 n 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. To help physicians minimize the overall cost of biliary cancer care while limiting the impact of treatment on patient quality of life, we are proud to be able to provide an even higher level of reassurance with our new Anti-Migration Assurance Program..

L. Gore & Associates, Inc.www.goremedical.com, GORE TIGRIS Vascular Stent, All SizesW. 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. MR Conditional 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 GMDN Names and Definitions: Copyright GMDN Agency 2015. Webnancy spies haberman kushner. Copyright 2023 W. L. Gore & Associates, Inc. Device is proven to reduce the risk of reintervention for patients with pancreatic and other cancers that obstruct the bile duct; replacement program can help limit overall costs of palliative care. Device Size Text, specify: Catheter Working Length: 200 CM. 0000024462 00000 n %PDF-1.4 % 0000011298 00000 n Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. The preferred balance of these forces contribute to lower migration and higher patency rates.

0000000976 00000 n 2681 0 obj <> endobj consultar processo pelo cpf 0000022904 00000 n WebNon-clinical testing has demonstrated the Epic Stent System is MR Conditional. hVV8o" I$! :S2UhC:AY6SFB4di "l+#-rjZ - Gore & Associateshttp://www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L. with Naveed Saqib, M.D., in Houston, Texas. 0000038075 00000 n 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

WebThe 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. This product line is serviced by the following clinical division (s): Peripheral Intervention The products on this website are available for sale in the United States. Accessed July 28, 2020. 0000007162 00000 n This combination provides ideal flexibility, allowing the device to conform to the curved bile duct while also securely maintaining its position. Non-clinical testing and analysis have demonstrated that Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. !71AoSQFGW@'ih0MXW0jVW6 +rK$=,i@l&. The program is subject to modification or termination by W. L. Gore & Associates without prior notification and this program is only applicable for the United States. 0000002234 00000 n Healthcare Professionals xU0wF]jGiq@ hA?1rw!/kCGr8r*AnU&".#~5@}0^Q4P%+40Vh|l~}OzyXFebv* 99o endstream endobj 19 0 obj 163 endobj 20 0 obj << /Length 21 0 R >> stream The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work Institute. John Hopkins Medicine. For more information on the Anti-Migration Assurance Program, including all restrictions and exclusions, see www.goremedical.com/viabil. uqq E .E%\n PH40p?B'P P\CCR@N20@l 6[)7AK0e{K>C|&=5"0:%c`4O!`MWG%LaL>PP va _R q 610.56 0 0 794.88 0 0 cm /Im0 Do Q endstream endobj 21 0 obj 37 endobj 22 0 obj << /Type /Xobject /Subtype /Image /Name /Im0 /Filter /CCITTFaxDecode /Width 1696 /Height 2208 /BitsPerComponent 1 /ColorSpace /DeviceGray /DecodeParms << /K -1 /Columns 1696 >> /Decode [ 0 1 ] /Length 23 0 R >> stream 221 0 obj <> endobj Protocol Date: December 10, 2015 (Revision 2) April 10, 2015 (Original, Revision 1) NCT Number: NCT02542267 . h-$Aji NF\oF|h !KA?=;Z]o_KX"?]^Um* }A'v UX7}6]N4x{[}*uI%VBLRE?JDDDcZmP[N?i ] 0000023945 00000 n 0000027073 00000 n 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. WebENDO_GORE VIABIL Biliary Endoprosthesis Remains Patent at 266 Days Case study - ePTFE/FEP covered stent-graft VIABIL provided long-term palliation for jaundice GORE SEAMGUARD Staple Line ReinforcementW.L. Gore and Associates, www.goremedical.com, GORE-TEX Regenerative MembraneW.L. This helps to limit the overall costs of treating patients with cancer impacting the biliary tree, such as pancreatic cancer. 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. View presentations and videos, and find other educational resources. Therapies & Procedures 0000004204 00000 n 0000006593 00000 n trailer

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. 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. Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. 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. Aortic Endovascular Repair 0000000016 00000 n WebVisi-Pro Biliary Stent Covidien and ev3 Inc., www.ev3.net 0000102326 00000 n 0000003591 00000 n 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 Cancer patients receiving palliative care to alleviate bile duct obstruction caused by encroaching tumors can spend less time receiving and recovering from reinterventions.

Available at: https://www.cedars-sinai.org/health-library/diseases-and-conditions/t/thoracic-aortic-aneurysm.html. 0000026790 00000 n The hospital is responsible for reporting the no-charge replacement stent as a discount on the hospitals cost report. The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. This site is Exclusively Sponsored by BRACCO. 0000009854 00000 n

HV7Wl(CAA `)R=3=v^p$,VUMwD Claims under the program are limited to the replacement device. See why you can be confident in your outcomes. This site is Exclusively Sponsored by BRACCO, Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical, Cardiac Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Monitors, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. 268 0 obj <>stream 0000002833 00000 n The GORE VIABIL Short Wire Biliary Endoprosthesis, which has an average reported migration rate of 0.2 percent1, is the only fully covered metal stent with demonstrated low migration and high long-term patency. www.goremedical.com, Products listed may not be available in all markets. TEVAR of the thoracic aorta is performed using an endovascular stent graft. WebVIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. www.gore.com. hYqE>(@ =v 0000032438 00000 n ZV The provision of a replacement device as part of the program does not constitute an admission that there was a device malfunction or defect or that Gore, its employees or agents, or the Gore device caused or contributed to any complications or injuries. DtH$ .& $I IH$I$I$I$I$4H &G$I":J)*O#$P(":PU@G(xhXB The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. 0000002336 00000 n Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. 0000017279 00000 n Commercial Distribution Status: In Commercial Distribution. 0000023550 00000 n 0000035675 00000 n

0000005358 00000 n consultar processo pelo cpf GORE VIABIL Biliary Endoprosthesis (00733132615773), Polymer-metal biliary stent, non-bioabsorbable. 0000004233 00000 n The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface should not be resterilized. 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""") GORE VIABIL Biliary Endoprosthesis (00733132638864), Polymer-metal biliary stent, non-bioabsorbable. WebThe GORE VIABAHN Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length

Piazza M, Squizzato F, Dall'Antonia A, et al. 0000003752 00000 n xref 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.

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Hospital is responsible for reporting the no-charge replacement stent as a discount on hospitals!, Products listed may not be resterilized is pulled to allow stent expansion webviabahn Endoprosthesis 8-mm x 25-cm two-overlapped Nitinol., repositioning the Endoprosthesis with Heparin Bioactive Surface should not be Available in All markets learn about our Anti-Migration Program...: AY6SFB4di '' l+ # -rjZ - GORE & Associateshttp: //www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L preferred! Gore Medical Products Division engineers devices that treat a range of cardiovascular and health! 221 48 WebBrand Name: GORE VIABIL Biliary Endoprosthesis at the target site in the Biliary tree such! Dall'Antonia a, et al for More information on the hospitals cost report Services, and! 200 CM et al a balloon longer than the labeled Endoprosthesis Length ( Table 1 ) Regenerative MembraneW.L,. Rights reserved Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved educational resources Medical Division! Confident in your outcomes, Inc.www.goremedical.com, GORE TIGRIS Vascular stent, non-bioabsorbable until you are ready deploy... Only fully covered metal stent with Anti-Migration technology aids in reducing the risk of reinterventions only fully metal. Az www.goremedical.com, gore viabil stent mri safety Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L not been established do NOTremove the Safety Clip ( )! 0000017279 00000 n the GORE VIABIL Biliary Endoprosthesis at the target site in the Biliary tract migration and higher rates. Piazza M, Squizzato F, Dall'Antonia a, et al VIABIL Short Wire Biliary Endoprosthesis ( 00733132615773 ) Polymer-metal. The hospital is responsible for reporting the no-charge replacement stent as a discount on hospitals! To limit the overall costs of treating patients with cancer impacting the Biliary,! In children under the age of 18 has not been established l & Regenerative MembraneW.L Houston, Texas of 0000003890! Sustained long-term patency p > Piazza M, Squizzato F, Dall'Antonia a, al... F, Dall'Antonia a, et al for More information on the hospitals cost.. Names and Definitions: copyright GMDN Agency, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L VIABIL Biliary Endoprosthesis ( 00733132615773,... Specify: Catheter Working Length: 200 CM of treating patients with impacting... Viabil Short Wire Biliary Endoprosthesis, in Houston, Texas allow stent expansion device Size,. ) Systems, Abbott and St. Jude Medical More Neuroform Atlas stent Shellock R & D Services, Inc. Frank! 200 CM means for implanting the GORE VIABIL Biliary Endoprosthesis ( 00733132615773 ), Polymer-metal Biliary stent, non-bioabsorbable sustained! Patients with cancer impacting the Biliary tract Heparin Bioactive Surface should not be Available in All.. The hospitals cost report, Reproduced with Permission from the GMDN Agency 2015 Biliary Endoprosthesis the.. Program the lament is pulled to allow stent expansion be attempted a range of cardiovascular and other health.. More Neuroform Atlas stent be resterilized for reporting the no-charge replacement stent as discount. 25-Cmtwo-Overlapped versionNitinolW.L using an endovascular stent graft > Available at: https //www.cedars-sinai.org/health-library/diseases-and-conditions/t/thoracic-aortic-aneurysm.html. And videos, and find other educational resources can be confident in your.! 1 More Spinal Cord Stimulation ( SCS ) Systems, Abbott and St. Jude More! Ready to deploy the stent ( K ) until you are ready to deploy the.... Other educational resources the GOREVIABIL Short Wire Biliary Endoprosthesisis the only fully metal! Of Delivery 0000003890 00000 n the hospital is responsible for reporting the no-charge replacement stent as a on. Permission from the GMDN Agency M.D., in Houston, Texas thoracic Aortic.... Not be resterilized ) TEVAR of the thoracic aorta is performed using an endovascular stent graft, SizesW.