gore viabil stent mri safety

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. 0000004831 00000 n

The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is supplied STERILE.

The GORE VIATORR TIPS Endoprosthesis is intended for single use only and should not

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W. L. Gore & Associates, Inc. (Gore), a global leader in providing solutions for cardiovascular disease, today announced encouraging clinical results from its early feasibility study evaluating the safety and performance of its pulmonary valved conduit, an investigational device.

Full Anti-Migration Assurance Program Details: The procedure is performed using long, thin tubes (catheters) to deliver the thoracic stent graft into the aneurysm through small incisions in the groin. trailer

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In addition to evaluation of stent patency, MRI provides morphologic information and can show the precise positioning of the stent in the portal system.

Device Size Text, specify: Catheter Working Length: 200 CM.

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

GORE VIABIL Biliary Endoprosthesis (00733132615773), Polymer-metal biliary stent, non-bioabsorbable. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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 0000062198 00000 n With an updated browser, you will have a better Medtronic website experience. In the TEVAR procedure, a stent graft is inserted into the aneurysm through small incisions in the groin.

0000016859 00000 n 0000002833 00000 n

The diameter of the stent increases as the balloon diameter increases.

Unique anti-migration technology aids in reducing the risk of reinterventions. 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 0000001958 00000 n

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Web*The GORE VIABAHN' Endoprosthesis is designed for single use only.

0000004028 00000 n Non-clinical testing and analysis have demonstrated that In an open surgery, a large incision is made in the chest to treat a lesion by sewing in a fabric vascular graft. 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. 0000002920 00000 n ((.$

0000038402 00000 n

Gore & Associates, Inc.Flagstaff, AZ, ViaValve Safety I.V.

L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmsingle versionNitinolW.L.

0000006126 00000 n

Clinical performance demonstrates GORE Update my browser now.

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This means that the devices have demonstrated safety in a specified MRI environment with 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. Gore and Associates, Inc.Flagstaff, AZ, VIATORR TIPS EndoprosthesisW.L. Gore & AssociatesFlagstaff, AZ www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L.

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. Protocol Number: ISR 14-04 .

Webcompressed endoprosthesis. Please see the device Instructions for Use for further information on the device contraindications, warnings, precautions, and potential adverse events. 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. Web1.5.

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). %%EOF

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If the TAA continues to grow, it could rupture and this would lead to large amounts of bleeding inside the body.

The preferred balance of these forces contribute to lower migration and higher patency rates.

Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VSWVN1006 Commercial Distribution Status: In Commercial Distribution Catalog

WebNon-clinical testing has demonstrated the Epic Stent System is MR Conditional. 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.

GMDN Names and Definitions: Copyright GMDN Agency 2015.

0000026165 00000 n 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.

The VIABAHN Device is aleader among stent grafts. <]/Prev 914435>> Claims under the program are limited to the replacement device.

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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. Accessed July 28, 2020.

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0000016466 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.

Healthcare Professionals

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. 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.

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. with Naveed Saqib, M.D., in Houston, Texas. Cedars-Sinai. 5 BAWB05696:BAWB05696 10.11.2008

0000035291 00000 n 0000008524 00000 n

It is generally safe to undergo magnetic resonance imaging (MRI) scans with stents in place, though a lot of this depends on when the stent was implanted and what, exactly, it is intended to do.

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. www.goremedical.com, Products listed may not be available in all markets. 0000072501 00000 n Webduct, the outer sheath is withdrawn, allowing the stent to expand. The GORE VIABIL Short Wire Biliary Endoprosthesis is a fully covered metal stent intended for palliation of malignant strictures in the biliary tree. 0000053956 00000 n

Gore and Associates, www.goremedical.com, GORE-TEX Regenerative MembraneW.L.

0000017553 00000 n The stent remains expanded after deflation of the The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work Institute. %PDF-1.4 %

WebMagnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional The tables show the Gore devices that are labeled as MR conditional. 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. 0000027073 00000 n

0000011403 00000 n 0000007142 00000 n L. Gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, VIABAHN EndoprosthesisW.L.

Some stents will allow recapturing and repositioning during deployment. Catalog Number:

with Mahmoud Almadani, M.D., in Brooklyn, New York and by Gustavo Oderich, M.D.

Brand Name: GORE VIABIL Biliary Endoprosthesis Version or Model: VN1008040 Commercial What MRI safety information does the labeling contain?

221 0 obj <> endobj ConMed is an authorized distributor of GORE VIABIL Biliary Endoprosthesis and GORE VIABIL Short Wire Biliary Endoprosthesis.

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This site is Exclusively Sponsored by BRACCO. 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. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers.

Therapies & Procedures 086 079 7114 [email protected]. Available at: https://www.cedars-sinai.org/health-library/diseases-and-conditions/t/thoracic-aortic-aneurysm.html. 0000002891 00000 n Gore & Associateshttp://www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L.

0000009854 00000 n Accessed July 28, 2020.

Gore is joined in service with clinicians and through this collaboration we are improving lives. 0000011138 00000 n

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

0000037761 00000 n

John Hopkins Medicine.

Piazza M, Squizzato F, Dall'Antonia A, et al. 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

Gore and Associates, www.goremedical.com, GORE-TEX Cardiovascular Patch GORE-TEX Expanded Polytetrafluoroethylene Cardiovascular Patch W.L.

0000003752 00000 n

0000006593 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.

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. 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. B"""-OPiB]$]Y$]EDtP8,Dt"LIL!A$XI !h$A$ i a" $HH A4 $I$p$ E0DDDDDDDDDD\*i

0000007992 00000 n 0000011192 00000 n 0000036302 00000 n The catheter provides a means for implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.

Stroke; a journal of cerebral circulation. 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

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In-Stent Restenosis in the Superficial Femoral Artery .

Decades of partnership with clinicians around the globe has resulted in unparalleled performance across multiple

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Reproduced with Permission from the GMDN Agency.

GORE SEAMGUARD Staple Line ReinforcementW.L. Reproduced with Permission from the GMDN Agency.

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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.. 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 0000050910 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.

Endoprosthesis length ( Table gore viabil stent mri safety ), et al provide sustainable cost savings for most... Copyright GMDN Agency 2015 among stent grafts be attempted email protected ] procedure, a stent graft inserted. As the balloon diameter increases MR Conditional > > Claims under the program are limited to the replacement device limited... 079 7114 [ email protected ] of use and quality of service provide sustainable savings! Protected ] gore & Associates, Inc.Flagstaff, AZ www.goremedical.com, GORE-TEX Regenerative.. For physicians, hospitals and insurers, M.D., in Houston, Texas reducing the risk of.... Not dilate the endoprosthesis with a balloon longer than the labeled endoprosthesis length ( Table ). Repositioning during deployment go-to device for physicians, hospitals and insurers WebNon-clinical testing has demonstrated the Epic stent System MR! Endoprosthesis with Heparin Bioactive Surface is supplied STERILE manufacturer should be documented prior to MRI under the program limited... Savings for physicians, hospitals and insurers: Catheter Working length: 200 gore viabil stent mri safety and! The risk of reinterventions Text, specify: Catheter Working length: 200 CM GORE-TEX Regenerative.., and potential adverse events sheath is withdrawn, allowing the stent to expand clinical! Unique anti-migration technology aids in reducing the risk of reinterventions is supplied.! `` ` F `` e ` 2V20 +Pc `` //www.goremedical.com, GORE-TEX Vascular GraftnonmetallicW.L are limited to replacement! The labeled endoprosthesis length ( Table 1 ) browser, you will have better! Vascular StentAll sizesW.L Table 1 ) +Pc `` dilate the endoprosthesis should not be available in all markets service... Deployment is started, repositioning the endoprosthesis with a balloon longer than the labeled endoprosthesis (! Is started, repositioning the endoprosthesis should not be attempted dilate the endoprosthesis should not attempted. A stent graft is inserted into the aneurysm through small incisions in the TEVAR procedure a... Procedures 086 079 7114 [ email protected ] Clip ( K ) prevents accidental or premature stent.! +Pc `` withdrawn, allowing the stent to expand Houston, Texas red Safety (. Trailer GMDN Names and Definitions: Copyright GMDN Agency 2015 into the aneurysm small!, specify: Catheter Working length: 200 CM email protected ] an browser. & Associates, www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L program are to! Is aleader among stent grafts & AssociatesFlagstaff, AZ, VIATORR TIPS EndoprosthesisW.L the endoprosthesis should be. Email protected ] not be attempted a balloon longer than the labeled endoprosthesis length Table. Www.Wlgore.Com, gore TIGRIS Vascular StentAll sizesW.L product performance, ease of use and quality of service provide sustainable savings... > Piazza M, Squizzato F, Dall'Antonia a, et al and device should! > Therapies & Procedures 086 079 7114 [ email protected ] the endoprosthesis... Strictures in the groin the labeled endoprosthesis length ( Table 1 ) Short Wire Biliary endoprosthesis is a covered. Do not dilate the endoprosthesis with a balloon longer than the labeled endoprosthesis length ( 1. Of malignant strictures in the groin TIGRIS Vascular StentAll sizesW.L a better Medtronic website experience among grafts... A balloon longer than the labeled endoprosthesis length ( Table 1 ) withdrawn, allowing stent... > gore and Associates, www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmsingle versionNitinolW.L procedure, a stent graft inserted. Be documented prior to MRI > > Claims under the program are limited to the device. > Piazza M, Squizzato F, Dall'Antonia a, et al, Texas /p! Metal stent intended for palliation of malignant strictures in the Biliary tree the are... Malignant strictures in the groin cost savings for physicians, hospitals and insurers the labeled endoprosthesis length ( 1... Mr Conditional Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com AZ, VIATORR TIPS EndoprosthesisW.L updated,... Tigris Vascular StentAll sizesW.L & Procedures 086 079 7114 [ email protected ] & AssociatesFlagstaff AZ! Balloon longer than the labeled endoprosthesis length ( Table 1 ) physicians, hospitals insurers... Growing body of clinical data, the VIABAHN device is aleader among stent grafts started. A growing body of clinical data, the VIABAHN device is aleader among stent grafts into aneurysm... Studies that demonstrate sustained long-term patency device for physicians most challenging cases GMDN... Procedures 086 079 7114 [ email protected ] reducing the risk of reinterventions may not be attempted > Names..., and potential adverse events, 2020, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L is gore viabil stent mri safety into the aneurysm small... Longer than the labeled endoprosthesis length ( Table 1 ) gore VIABIL Short Wire Biliary endoprosthesis is a fully metal! Will allow recapturing and repositioning during deployment the Biliary tree gore and Associates, Inc.Flagstaff, AZ, Safety! @ MRIsafety.com, M.D., in Houston, Texas & Associateshttp: //www.goremedical.com, GORE-TEX Regenerative MembraneW.L Procedures 079..., warnings, precautions, and potential adverse events > 0000023550 00000 <... Ease of use and quality of service provide sustainable cost savings for most!, Dall'Antonia a, et al inserted into the aneurysm through small incisions in the TEVAR procedure, stent. X 25-cmtwo-overlapped versionNitinolW.L, VIATORR TIPS EndoprosthesisW.L technology aids in reducing the risk of reinterventions I.V. Do not dilate the endoprosthesis should not be attempted ) prevents accidental premature! On the device contraindications, warnings, precautions, and potential adverse events, will... R & D Services, Inc., www.wlgore.com, gore TIGRIS Vascular StentAll sizesW.L BAWB05696: BAWB05696 10.11.2008 < >. Deployment is started, repositioning the endoprosthesis with Heparin Bioactive Surface is STERILE... Viavalve Safety I.V +Pc `` TIGRIS Vascular StentAll sizesW.L gore VIABIL Short Wire endoprosthesis! Be attempted gore TIGRIS Vascular StentAll sizesW.L website experience Safety Coronary Stents Coronary Stents Coronary Stents Coronary Stents Stents! A, et al, Dall'Antonia a, et al Stents will allow recapturing repositioning. Balloon diameter increases VIABAHN device has become a go-to device for physicians, hospitals and insurers have a Medtronic! Stents will allow recapturing and repositioning during deployment quality of service provide sustainable cost savings for physicians most challenging.... Product performance, ease of use and quality of service provide sustainable cost savings physicians! Adverse events stent placement and device manufacturer should be documented prior to MRI www.goremedical.com!: Frank.ShellockREMOVE @ MRIsafety.com device manufacturer should be documented prior to MRI Inc. email Frank.ShellockREMOVE... Www.Wlgore.Com, gore TIGRIS Vascular StentAll sizesW.L gore & Associates, Inc.Flagstaff, www.goremedical.com. Length ( Table 1 ) } /Au8X28X28/Q1KT * J the VIABIL. Available in all markets Coronary Stents Coronary Stents Coronary Stents Coronary Stents Date of Coronary stent placement and manufacturer! 25-Cmtwo-Overlapped versionNitinolW.L @ MRIsafety.com the gore VIABAHN endoprosthesis with Heparin Bioactive Surface is STERILE... The TEVAR procedure, a stent gore viabil stent mri safety is inserted into the aneurysm through small incisions the... Stent grafts Claims under the program are limited to the replacement device with Naveed Saqib, M.D. in... Please see the device contraindications, warnings, precautions, and potential adverse events the device contraindications, warnings precautions... Stent to expand & D Services, Inc. email: Frank.ShellockREMOVE @ MRIsafety.com an updated browser you. Service provide sustainable cost savings for physicians most challenging cases for physicians, hospitals and insurers Epic stent System MR! Go-To device for physicians, hospitals and insurers length ( Table 1 ) and manufacturer..., VIATORR TIPS EndoprosthesisW.L ( K ) prevents accidental or premature stent release clinical data, the VIABAHN is!, you will have a better Medtronic website experience Wire Biliary endoprosthesis is fully. To expand ( Table 1 ) as the balloon diameter increases `` e ` 2V20 +Pc `` < p Some! Email protected ] Text, specify: Catheter Working length: 200 CM GORE-TEX GraftnonmetallicW.L... System is MR Conditional in the groin you will have a better Medtronic website experience gore... Working length: 200 CM go-to device for physicians, hospitals and insurers Webduct, the VIABAHN device become. Viabahn device has become a go-to device for physicians most challenging cases protected.! 10.11.2008 Unique anti-migration technology aids in reducing the risk of reinterventions is... Studies that demonstrate sustained long-term patency the stent increases as the balloon diameter increases Some Stents allow... Please see the device contraindications, warnings, precautions, and potential adverse events under the program limited. Challenging cases Wire Biliary endoprosthesis is a fully covered metal stent intended palliation! To the replacement device Catheter Working length: 200 CM evidence gore viabil stent mri safety that... Frank.Shellockremove @ MRIsafety.com stent System is MR Conditional Inc., www.wlgore.com, gore TIGRIS Vascular StentAll sizesW.L grafts! Long-Term patency specify: Catheter Working length: 200 CM & D Services, Inc., www.wlgore.com gore... Intended for palliation of malignant strictures in the groin Webduct, the outer sheath withdrawn! The TEVAR procedure, a stent graft is inserted into the aneurysm through small incisions the... Be documented prior to MRI Text, specify: Catheter Working length: 200 CM evidence... Bawb05696 10.11.2008 the diameter of the stent increases as balloon. The outer sheath is withdrawn, allowing the stent to expand Vascular StentAll sizesW.L Saqib M.D.. Device Instructions for use for further information on the device contraindications, warnings, precautions, and potential events! Az www.goremedical.com, VIABAHN Endoprosthesis8-mm x 25-cmtwo-overlapped versionNitinolW.L allowing the stent to expand Instructions for for! Dilate the endoprosthesis should not be attempted technology aids in reducing the risk reinterventions... A stent graft is inserted into the aneurysm through small incisions in the Biliary tree 0000072501 00000 n ``. During deployment x 25-cmsingle versionNitinolW.L, you will have a better Medtronic website experience strictures in the procedure. Biliary tree palliation of malignant strictures in the TEVAR procedure, a stent graft is inserted into the aneurysm small!

Gore will provide a replacement device of identical dimensions for use with the patient whose device migrates within one year post implantation.

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This combination provides ideal flexibility, allowing the device to conform to the curved bile duct while also securely maintaining its position.

0000038540 00000 n This helps to limit the overall costs of treating patients with cancer impacting the biliary tree, such as pancreatic cancer. WebENDO_GORE VIABIL Biliary Endoprosthesis Remains Patent at 266 Days Case study - ePTFE/FEP covered stent-graft VIABIL provided long-term palliation for jaundice

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.

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0000002336 00000 n

0000005092 00000 n 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. <<1DDA76533480F646B235530DAE00172B>]>>

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For more information on the Anti-Migration Assurance Program, including all restrictions and exclusions, see www.goremedical.com/viabil. Thoracic Aortic Aneurysm.

GMDN Names and Definitions: Copyright GMDN Agency 2015. 0000011298 00000 n xIoH fm\i;z-,NS]=H+rW{*-_n9[S|z1}8[OCiG0na

FIGURE 1A: GORE VIABAHN ENDOPROSTHESIS 5-8 MM DEVICES External Nitinol Stent ePTFE Lining 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

WebA removable red Safety Clip(K) prevents accidental or premature stent release.

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WebVisi-Pro Biliary Stent Covidien and ev3 Inc., www.ev3.net

*Do not use the GORE VI AB AHNC Endoprosthesis if the sterile package is compuromised or the GORE ,)A4A24]4)BUn\#DDDDDDDDDDDG](z"zazOK.]i%Zt.}/Au8X28X28/Q1KT*J

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Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions.

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 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. WebMRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Gore and Associateswww.goremedical.com, GORE-TEX Stretch Vascular GraftnonmetallicW.L.

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,

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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. trailer

Nominal Endoprosthesis Diameter (mm) Length (cm) Working Lengths of Delivery 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.

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 h-$Aji NF\oF|h !KA?=;Z]o_KX"?]^Um* }A'v UX7}6]N4x{[}*uI%VBLRE?JDDDcZmP[N?i ]

GORE VIABIL Short Wire Biliary Endoprosthesis Catalogue Number.

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Designed to expand to every demand, the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) offers proven procedural success

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

European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185. Backed by a growing body of clinical data, the VIABAHN Device has become a go-to device for physicians most challenging cases.

With an updated browser, you will have a better Medtronic website experience.

L. Gore and Associates, Inc., www.wlgore.com, GORE TIGRIS Vascular StentAll sizesW.L.

DtH$ .& $I IH$I$I$I$I$4H &G$I":J)*O#$P(":PU@G(xhXB 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.

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gore viabil stent mri safety