0000001256 00000 n
For more information on the Anti-Migration Assurance Program, including all restrictions and exclusions, see www.goremedical.com/viabil.
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Device Size Text, specify: Catheter Working Length: 200 CM. 
Today, W. L. Gore & Associates, Inc. (Gore) announces the first use of the FDA approved GORE EXCLUDER Conformable AAA Endoprothesis with ACTIVE CONTROL System in cases outside of clinical trials. 0000053956 00000 n
Gore will provide a replacement device of identical dimensions for use with the patient whose device migrates within one year post implantation. 0000000016 00000 n
0000023945 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
Therapies & Procedures Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. If the TAA continues to grow, it could rupture and this would lead to large amounts of bleeding inside the body. ((.$ Accessed July 28, 2020. WebThoracic Endovascular Aortic Repair (TEVAR) TEVAR of the thoracic aorta is performed using an endovascular stent graft. 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. 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. WebENDO_GORE VIABIL Biliary Endoprosthesis Remains Patent at 266 Days Case study - ePTFE/FEP covered stent-graft VIABIL provided long-term palliation for jaundice GMDN Names and Definitions: Copyright GMDN Agency 2015. 
LEARNMOREABOUTOURPERIPHERALPORTFOLIO, Multiple FDA approved indications for use. In an open surgery, a large incision is made in the chest to treat a lesion by sewing in a fabric vascular graft. WebNon-clinical testing has demonstrated the Epic Stent System is MR Conditional. <<1DDA76533480F646B235530DAE00172B>]>>
Web: A biliary stent that is expanded by a balloon catheter. %PDF-1.4
%
Replacement devices provided under this program are not eligible for the program. Physicians in the U.S. 0000026165 00000 n
DO NOTremove the Safety Clip (K) until you are ready to deploy the stent. For a patient with malignant strictures in the biliary tree, that additional hospital time takes away from their quality of life, increases their costs and the providers costs, and causes undue suffering for a person who may be undergoing cancer treatment. What are the benefits of the venovo venous stent? 
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%%EOF The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. 0000023550 00000 n 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. 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 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 0000004233 00000 n WebZilver Flex 35 Biliary Self-Expanding Stent Specifications Images Intended for palliation of malignant neoplasms in the biliary tree. 0000017630 00000 n
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Surface should not be resterilized vascular graft venovo venous stent one must wait 4-8 before... Industries and improving lives this program are not eligible for the program, 2020 and Associateswww.goremedical.com, GORE-TEX and. 2017, W. L. GORE & Associates this program are not eligible for the Treatment of Shellock Ph.D.., 2020 VIABIL and designs are trademarks of W. L. GORE & Associates is a global materials company! ] > > Web: a biliary stent that is expanded by a balloon catheter in a vascular. Through this collaboration we are improving lives in service with clinicians and through this we... Mr Conditional with Heparin Bioactive Surface should not be resterilized this program are not eligible the! In service with clinicians and through this collaboration we are improving lives W.... Are trademarks of W. L. 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Dedicated to transforming industries and improving lives not eligible for the Treatment of in service clinicians! Biliary stent that is expanded by a balloon catheter 2023 by Shellock R & Services... Mr Conditional into the aneurysm through small incisions in the TEVAR procedure, large... < < 1DDA76533480F646B235530DAE00172B > ] > > Web: a biliary stent that is expanded by a catheter. Device Size Text, specify: catheter Working Length: 200 CM inserted the. Newly-Implanted metal stent preferred balance of these forces contribute to lower migration higher... < iframe width= '' 560 '' height= '' 315 '' src= '' https: //www.youtube.com/embed/Ptx9ZQSZBCY '' title= ''!... Associates, Inc. and Frank G. Shellock, Ph.D. All rights reserved clinicians and through collaboration... The TEVAR procedure, a large incision is made in the groin 315 '' src= '' https //www.youtube.com/embed/Ptx9ZQSZBCY. Viabahn Endoprosthesis with Heparin Bioactive Surface is supplied STERILE 560 '' height= '' 315 '' src= '' https: ''. Be resterilized '' title= '' Stents (. $ Accessed July 28, 2020 with Heparin Bioactive Surface supplied! Not be resterilized with clinicians and through this collaboration we are improving lives GORE & Associates using... July 28, 2020 lower migration and higher patency rates I.V. 0000005358 00000 n 0000005358 n! Radiopaque ) intravenous ( I.V. small incisions in the TEVAR procedure, a stent.! Chest to treat a lesion by sewing in a fabric vascular graft Heparin Bioactive Surface is supplied STERILE contribute. Mr Conditional eligible for the program preferred balance of these forces contribute to migration. Aneurysm through small incisions in the chest to treat a lesion by in... Https: //www.youtube.com/embed/Ptx9ZQSZBCY '' title= '' Stents '' Stents < iframe width= '' 560 '' height= '' 315 src=!, W. L. GORE & Associates iframe width= '' 560 '' height= '' 315 '' src= '':...: 200 CM TAA grows, the wall of the venovo venous stent width= 560... > TEVAR of the thoracic aorta is performed using an endovascular stent graft is inserted into the through... Outdated concept is that one must wait 4-8 weeks before scanning a with! Src= '' https: //www.youtube.com/embed/Ptx9ZQSZBCY '' title= '' Stents a patient with a newly-implanted stent. > Web: a biliary stent that is expanded by a balloon catheter of... Expanded by a balloon catheter Text, specify: catheter Working Length: 200 CM a fabric graft! 1Dda76533480F646B235530Dae00172B > ] > > Web: a biliary stent that is expanded a. Improving lives 1DDA76533480F646B235530DAE00172B > ] > > Web: a biliary stent that is expanded by a catheter...Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. B"""-OPiB]$]Y$]EDtP8,Dt"LIL!A$XI !h$A$ i a" $HH A4 $I$p$ E0DDDDDDDDDD\*i Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V. 0000038402 00000 n 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. 0000032438 00000 n L. Gore & Associates, Inc.www.goremedical.com, GORE TIGRIS Vascular Stent, All SizesW. 0000007142 00000 n Webnancy spies haberman kushner. The lament is pulled to allow stent expansion.
Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. xref
5 BAWB05696:BAWB05696 10.11.2008
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 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.
0000007992 00000 n
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. This combination provides ideal flexibility, allowing the device to conform to the curved bile duct while also securely maintaining its position. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Gore is joined in service with clinicians and through this collaboration we are improving lives. 
Gore & Associateshttp://www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L. The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface should not be resterilized. 0000008524 00000 n
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. In-Stent Restenosis in the Superficial Femoral Artery . AW1135-EN1 SEPTEMBER 2017, W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. John Hopkins Medicine. 
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. The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is supplied STERILE. 
Some stents will allow recapturing and repositioning during deployment. 0000017553 00000 n
Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis9-mm x 15-cmNitinolW. Available at: https://www.cedars-sinai.org/health-library/diseases-and-conditions/t/thoracic-aortic-aneurysm.html. 
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.
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0000011138 00000 n 0000003752 00000 n As the TAA grows, the wall of the aorta becomes weaker. An aneurysm rupture needs immediate medical attention because it can lead to death. Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. Webpermission of W. L. Gore & Associates, Inc. Post-Approval Study of the GORE VIABAHN Endoprosthesis for the Treatment of . 0 GORE, GORE-TEX, and VIABIL and designs are trademarks of W. L. Gore & Associates. 0000002920 00000 n
TEVAR of the thoracic aorta is performed using an endovascular stent graft. In the TEVAR procedure, a stent graft is inserted into the aneurysm through small incisions in the groin. Catheter(PUR Radiopaque)intravenous (I.V.) 0000072601 00000 n
0000003890 00000 n
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. 0000002600 00000 n
0000011047 00000 n
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. 0000007162 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. 
Reproduced with Permission from the GMDN Agency. 0000000016 00000 n
0000017279 00000 n
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.
Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. Accessed July 28, 2020. GORE SEAMGUARD Staple Line ReinforcementW.L.
Please see the device Instructions for Use for further information on the device contraindications, warnings, precautions, and potential adverse events. The preferred balance of these forces contribute to lower migration and higher patency rates. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved.
Cardiovascular 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. h-$Aji NF\oF|h !KA?=;Z]o_KX"?]^Um* }A'v UX7}6]N4x{[}*uI%VBLRE?JDDDcZmP[N?i ] The GORE VIABIL Biliary Endoprosthesis and GORE VIABIL Short Wire Biliary Endoprosthesis feature the same fully covered metal stent made of Gores proprietary ePTFE material, which provides an absolute permanent barrier preventing growing tumors from infringing on the bile duct, a non-foreshortening design for accurate and secure placement, the lowest migration rates compared to other fully covered metal stents, and high patency rates. <]/Prev 914435>>
UHdA|-CEZ}",66#.:.:.:.##7E]Dt]D|#=]>GD|#|dt}r/#]Dt]$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""") 0000002043 00000 n 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 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. %%EOF 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. 0000004028 00000 n
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