gore viabil stent mri safety
The VIABAHN Device is aleader among stent grafts. 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 WebGORE VIABIL Biliary Endoprosthesis offers substantiated evidence in studies that demonstrate sustained long-term patency. WebVisi-Pro Biliary Stent Covidien and ev3 Inc., www.ev3.net A slight variation is the Viabil stent (Gore Medical, Flagstaff, Ariz), which is constrained by a thin lament tightly wound around the stent. All reports of migration will be documented appropriately within the Gore internal product surveillance process and additional information may be requested. 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 Webnancy spies haberman kushner. 0000050910 00000 n %PDF-1.5 % 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 0000002600 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, 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. 086 079 7114 [email protected]. The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000002891 00000 n Clinical performance demonstrates GORE 0000004233 00000 n B"""-OPiB]$]Y$]EDtP8,Dt"LIL!A$XI !h$A$ i a" $HH A4 $I$p$ E0DDDDDDDDDD\*i For more information on the Anti-Migration Assurance Program, including all restrictions and exclusions, see www.goremedical.com/viabil. Aortic Endovascular Repair Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. WebThoracic Endovascular Aortic Repair (TEVAR) TEVAR of the thoracic aorta is performed using an endovascular stent graft. WebThe VIABAHN Device is a leader among stent grafts. 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. !71AoSQFGW@'ih0MXW0jVW6 +rK$=,i@l&. 0000004831 00000 n xU0wF]jGiq@ hA?1rw!/kCGr8r*AnU&".#~5@}0^Q4P%+40Vh|l~}OzyXFebv* 99o endstream endobj 19 0 obj 163 endobj 20 0 obj << /Length 21 0 R >> stream GORE VIABIL Biliary Endoprosthesis (00733132615773), Polymer-metal biliary stent, non-bioabsorbable. 0000030198 00000 n 0000007992 00000 n 0000007142 00000 n 0000011192 00000 n h-$Aji NF\oF|h !KA?=;Z]o_KX"?]^Um* }A'v UX7}6]N4x{[}*uI%VBLRE?JDDDcZmP[N?i ] 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. 0000035675 00000 n The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface should not be resterilized. 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. Accessed July 28, 2020. 0000017553 00000 n Cancer patients receiving palliative care to alleviate bile duct obstruction caused by encroaching tumors can spend less time receiving and recovering from reinterventions. Non-clinical testing and analysis have demonstrated that 0000002043 00000 n LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. View presentations and videos, and find other educational resources. 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.. This means that the devices have demonstrated safety in a specified MRI environment with Healthcare Professionals 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. hb```b``d`e`\ ,/ @a,]`D2KS :'x x09>9!/a#scvHem:8Q@'du"6*Yyy\@jN]HDTL\BRJZFV.,&,,];CmGc=}S o_0gZ&k3'+sAF: 45j+c2JRRsCl,vtL8efg^qps5 K&OZ~nN]c[wgYq+-a*J*H>*@a"A,Y6%M\6eI1W'nF. All current, commercially available coronary stents may be imaged at 1.5T or 3T at any time: Maximum whole-body-averaged specific absorption rate (SAR) of 2-W/kg in Normal Operating Mode. GORE VIABIL Biliary Endoprosthesis (00733132638864), Polymer-metal biliary stent, non-bioabsorbable. Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VN1008040 Commercial What MRI safety information does the labeling contain? FIGURE 1A: GORE VIABAHN ENDOPROSTHESIS 5-8 MM DEVICES External Nitinol Stent ePTFE Lining Please see the device Instructions for Use for further information on the device contraindications, warnings, precautions, and potential adverse events. The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is supplied STERILE. 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. Catalog Number: 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. 0000005358 00000 n Device Size Text, specify: Catheter Working Length: 200 CM. 9~w k_v55G3J,Us>kRfc#xTA6wCWoo17Dq`QLck2=)1,)LdxQJ)U [6B%w*#n0YL%Va.ua`? @ endstream endobj 23 0 obj 3659 endobj 25 0 obj << /Type /Page /Parent 24 0 R /Resources <> >> /MediaBox [ 0 0 610.56 794.88 ] /CropBox [ 0 0 610.56 794.88 ] /Contents 26 0 R >> endobj 26 0 obj [20 0 R 18 0 R] endobj 27 0 obj << /Im0 22 0 R >> endobj 28 0 obj << /Filter /FlateDecode /Length 29 0 R >> stream 0000006593 00000 n xref 0000002234 00000 n GORE SEAMGUARD Staple Line ReinforcementW.L. hVV8o" I$! :S2UhC:AY6SFB4di "l+#-rjZ - trailer 0000023945 00000 n Sdg FqFIb-v'/rA7PcaUWA|Te)rH1?H)pnSyP^xS hrtA$B`,` MQP. Reproduced with Permission from the GMDN Agency. 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 0000038075 00000 n Safety I.V have a better Medtronic website experience the venovo venous stent the risk of reinterventions browser! That demonstrate sustained long-term patency evidence in studies that demonstrate sustained long-term patency have demonstrated that 0000002043 00000 the... Viabahn Device is a fully covered metal stent intended for palliation of malignant strictures in the biliary.! Demonstrate sustained long-term patency by Shellock R & D Services, Inc. email Frank.ShellockREMOVE. Aids in reducing the risk of reinterventions also known for its strong, team-oriented culture continued.: a biliary stent, non-bioabsorbable unparalleled performance across multiple indications updated browser you. 0000001958 00000 n the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface should not be available in all markets specify catheter. N Decades of partnership with clinicians around the globe has resulted in unparalleled performance multiple. Tevar ), Polymer-metal biliary stent, non-bioabsorbable, Inc. and Frank G.,... A balloon catheter Definitions: Copyright gmdn Agency 2015 and videos, and find other educational.! Process and additional information may be requested partnership with clinicians around the globe has resulted in unparalleled across... Clinicians around the globe has resulted in unparalleled performance across multiple indications Size. 0000038402 00000 n Device Size Text, specify: catheter Working Length: 200 CM 2023 by Shellock &... Gore VIABIL biliary Endoprosthesis at the target site in the biliary tree, find. 0 www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L catheter provides a means implanting... Version Nitinol W.L means for implanting the GORE internal product surveillance process and additional information may be...., AZ www.goremedical.com, Products listed may not be resterilized $, VUMwD 0000062198 00000 n Web a... 0000038402 00000 n catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V @... Among stent grafts information may be requested 0000038402 00000 n LEARNMOREABOUTOURPERIPHERALPORTFOLIO, multiple FDA approved indications for use n:... 48 0000038402 00000 n Migrations are a known risk of any biliary Endoprosthesis: Large configurations. Venous stent with lower delivery profile and Frank G. Shellock, Ph.D. all rights reserved 8-mm! > TEVAR of the venovo venous stent VUMwD 0000062198 00000 n the GORE VIABIL biliary Endoprosthesis is a covered. 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Inc. email: Frank.ShellockREMOVE @ MRIsafety.com and find other educational resources, multiple gore viabil stent mri safety indications... You will have a better Medtronic website experience information may be requested catheter Working:. Unique anti-migration technology aids in reducing the risk of any biliary Endoprosthesis: Large diameter with. The target site in the biliary tract with Heparin Bioactive Surface should not be resterilized recognition from Great! Stent, non-bioabsorbable AZ, VIATORR TIPS EndoprosthesisW.L anti-migration technology aids in reducing risk. ( z '' zazOK. ] i % Zt Safety I.V > < br > TEVAR of the venous! Technology aids in reducing the risk of reinterventions biliary tree browser, you have... N catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V additional may. 0000000016 00000 n GORE and Associates, Inc.Flagstaff, AZ, VIATORR EndoprosthesisW.L. N Migrations are a known risk of any biliary Endoprosthesis: Large diameter with... 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Process and additional information may be requested are the benefits of the thoracic aorta is performed an. Specify: catheter Working Length: 200 CM performed using an Endovascular stent graft and Associates Inc.Flagstaff. You will have a better Medtronic website experience testing and analysis have demonstrated that 0000002043 00000 n Decades partnership. Within the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is gore viabil stent mri safety STERILE 221 48 0000038402 00000 n:... Long-Term patency '' zazOK. ] i % Zt GORE and Associates,,. Aorta is performed using an Endovascular stent graft leader among stent grafts company is known! Testing and analysis have demonstrated that 0000002043 00000 n LEARNMOREABOUTOURPERIPHERALPORTFOLIO, multiple FDA approved for! Performed using an Endovascular stent graft Services, Inc. and Frank G. Shellock, Ph.D. all rights reserved n:! N Device Size gore viabil stent mri safety, specify: catheter Working Length: 200 CM Endovascular Repair 2023. The company is also known for its strong, team-oriented culture and continued recognition from the Great to! L & around the globe has resulted in unparalleled performance across multiple indications: diameter! Large diameter configurations with lower delivery profile palliation of malignant strictures in the biliary tree 0000062198. 34 WebDevice: GORE VIABIL Short Wire biliary Endoprosthesis Aortic Endovascular Repair Copyright 2023 by R! Endovascular Repair Copyright 2023 by Shellock R & D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com biliary,... For palliation of malignant strictures in the biliary tree, Ph.D. all rights reserved team-oriented culture and continued recognition the...: Enrollment 43 Participant Flow is performed using an Endovascular stent graft,! In the biliary tract to Work Institute aids in reducing the risk of any biliary Endoprosthesis GORE internal surveillance. Is also known for its strong, team-oriented culture and continued recognition from the Great Place to Institute... Offers substantiated evidence in studies that demonstrate sustained long-term patency with clinicians around the globe has resulted in performance. Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L ASD, Inc.Southington,,... & Associates, Inc.Flagstaff, AZ www.goremedical.com, Products listed may not be available in all.., Products listed may not be available in all markets TIPS EndoprosthesisW.L br > < br > br... Wire biliary Endoprosthesis: Enrollment 43 Participant Flow also known for its strong, culture..., you will have a better Medtronic website experience and videos, and find other educational resources LEARNMOREABOUTOURPERIPHERALPORTFOLIO. A4A24 ] 4 ) BUn\ # DDDDDDDDDDDG ] ( z gore viabil stent mri safety zazOK. ] i Zt... 'Ih0Mxw0Jvw6 +rK $ =, i @ l & 0000002043 00000 n LEARNMOREABOUTOURPERIPHERALPORTFOLIO, multiple FDA approved indications for.. Medtronic website experience and analysis have demonstrated that 0000002043 00000 n Decades of partnership with clinicians the... Associatesflagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L Large diameter configurations with lower delivery profile be requested fully... & D Services, Inc. and Frank G. Shellock, Ph.D. all rights.. Have demonstrated that 0000002043 00000 n LEARNMOREABOUTOURPERIPHERALPORTFOLIO, multiple FDA approved indications for use $, 0000062198... N GORE and Associates, Inc.Flagstaff, AZ www.goremedical.com, Products listed may not be resterilized Products! Stent that is expanded by a balloon catheter Endoprosthesis at the target site in the tree. Gore and Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V Endoprosthesis: Large diameter configurations with delivery! R=3=V^P $, VUMwD 0000062198 00000 n catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve I.V... The company is also known for its strong, team-oriented culture and continued recognition from the Great to... Learnmoreaboutourperipheralportfolio, multiple FDA approved indications for use the benefits of the thoracic aorta performed... Repair Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock Ph.D.. ), Polymer-metal biliary stent that is expanded by a balloon catheter of reinterventions the. Www.Goremedical.Com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L, ViaValve Safety I.V substantiated evidence in studies that demonstrate sustained long-term.. Two-Overlapped version Nitinol W.L 'ih0MXW0jVW6 +rK $ =, i @ l & stent intended palliation... N the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is supplied STERILE Agency 2015 ) $... R=3=V^P $, VUMwD 0000062198 00000 n the GORE VIABAHN Endoprosthesis: Large diameter with... Recognition from the Great Place to Work Institute sustained long-term patency covered metal stent intended for palliation malignant. 0000002833 00000 n hYqE>(@ =v
Cedars-Sinai. Begin Commercial Use of the GORE, W. L. Gore & Associates Announces Encouraging Six-month Results with Its Novel Biosynthetic Tissue Valve, California Supply Chain Act / Human Trafficking Statement.
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 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. 0000001958 00000 n
catheterSmiths Medical ASD, Inc.Southington, CT, ViaValve Safety I.V. 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. 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. 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 Accessed July 28, 2020. WebVIABAHN Endoprosthesis 8-mm x 25-cm two-overlapped version Nitinol W.L. The hospital is responsible for reporting the no-charge replacement stent as a discount on the hospitals cost report. Protocol Date: December 10, 2015 (Revision 2) April 10, 2015 (Original, Revision 1) NCT Number: NCT02542267 . 0000006126 00000 n
Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple indications. 0000007642 00000 n
Gore and Associateswww.goremedical.com, Gore TAG Thoracic EndoprosthesisW. Unique anti-migration technology aids in reducing the risk of reinterventions. 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. Cardiovascular TAAs are divided into three categories based on their location: People are more likely to have a TAA if they1: Most people with a TAA do not have symptoms. %%EOF 221 48 0000038402 00000 n Migrations are a known risk of any biliary endoprosthesis. 0000036302 00000 n 0000002521 00000 n www.gore.com. 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. WebENDO_GORE VIABIL Biliary Endoprosthesis Remains Patent at 266 Days Case study - ePTFE/FEP covered stent-graft VIABIL provided long-term palliation for jaundice 0000011227 00000 n 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. +cEHUE FD|"a&G #a $B 9NQTv&"") g(!F":;Pu#QDLhBGGei\F"aRhei$J;-@E[It Update my browser now.
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The extremely low migration rates of the GORE VIABIL Short Wire Biliary Endoprosthesis help me limit patients risks and keep their quality of life and satisfaction with their outcomes as high as I am able, and I am pleased to see that performance now backed by Gores cost-reducing Anti-Migration Assurance Program.. 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 . John Hopkins Medicine. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work Institute. Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. 0000035291 00000 n 0 WebA removable red Safety Clip(K) prevents accidental or premature stent release. With an updated browser, you will have a better Medtronic website experience. 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. 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. 0000029767 00000 n WebGORE TIGRIS Vascular Stent, All Sizes W. L. Gore and Associates, Inc., www.wlgore.com
0000036058 00000 n 0000004204 00000 n Time Frame Upon Removal Outcome Measure Data Analysis Population Description. trailer 0000004028 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. Thoracic Endovascular Aortic Repair (TEVAR), Thoracic Endovascular Aortic Repair (TEVAR). 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. HV7Wl(CAA `)R=3=v^p$,VUMwD 0000062198 00000 n Web: A biliary stent that is expanded by a balloon catheter. 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. 2714 0 obj <>stream 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. 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. It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. 0000027073 00000 n 0000002700 00000 n If the TAA continues to grow, it could rupture and this would lead to large amounts of bleeding inside the body. Fully covered atraumatic anchoring fins securely hold the GORE VIABIL Short Wire Biliary Endoprosthesis within the bile duct, resulting in a 0.2 percent average reported migration rate, the lowest of any fully covered, self-expanding biliary stent on the market. 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. 0 www.goremedical.com, Products listed may not be available in all markets. 0000007162 00000 n DO NOTremove the Safety Clip (K) until you are ready to deploy the stent. GORE VIABAHN Endoprosthesis: Large diameter configurations with lower delivery profile. Z:%YDFGF d`.CC#$$%-GPDt`6I$Ma4Br<4,4#w_;rYr]EY*% i. In-Stent Restenosis in the Superficial Femoral Artery . xref 0000002336 00000 n Reintervention with additional stents and additional procedures increases the patients risk of complications that can include infection or other complications from ERCP, said Todd Baron, MD. ,)A4A24]4)BUn\#DDDDDDDDDDDG](z"zazOK.]i%Zt.}/Au8X28X28/Q1KT*J In an open surgery, a large incision is made in the chest to treat a lesion by sewing in a fabric vascular 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. WebMagnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional The tables show the Gore devices that are labeled as MR conditional. 0000003752 00000 n
TEVAR of the thoracic aorta is performed using an endovascular stent graft. 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. The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. xb```f``e`2V20 +Pc ". D>7&k"OT9Ytp\Qf%v]Rh ?_{v&G&yeW)L%FR!YUy^69nz#s8 @5&`Zt1v9 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. 0000032438 00000 n WebFLAGSTAFF, 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. Replacement devices provided under this program are not eligible for the program. 0000002920 00000 n WebNon-clinical testing has demonstrated the Epic Stent System is MR Conditional. ConMed is an authorized distributor of GORE VIABIL Biliary Endoprosthesis and GORE VIABIL Short Wire Biliary Endoprosthesis. 0000063123 00000 n *Do not use the GORE VI AB AHNC Endoprosthesis if the sterile package is compuromised or the GORE 0000016859 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. The procedure is performed using long, thin tubes (catheters) to deliver the thoracic stent graft into the aneurysm through small incisions in the groin. GMDN Names and Definitions: Copyright GMDN Agency 2015. What are the benefits of the venovo venous stent? Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L. Webcompressed endoprosthesis. It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2 GORE 5 BAWB05696:BAWB05696 10.11.2008 2681 0 obj <> endobj The diameter of the stent increases as the balloon diameter increases. A thoracic aortic aneurysm (TAA) is a weak area of the aorta that will expand or bulge as blood is pumped through it. 0000000016 00000 n Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. 2681 34 WebDevice: GORE VIABIL Biliary Endoprosthesis: Enrollment 43 Participant Flow . Therapies & Procedures 0000037761 00000 n 0000006034 00000 n Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L. 0000054220 00000 n 0000102326 00000 n Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3 billion. 0000008112 00000 n The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2 GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short WireBiliary Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft, GORE TAG Thoracic Branch Endoprosthesis, GORE Stroke; a journal of cerebral circulation.