What do you do about tracheobronchial airway devices like stents, valves and coils. Randomized trials of mechanical thrombectomy (MT) generally exclude patients over the age of 80 years with baseline disability. Avoid unnecessary handling, which may kink or damage the Delivery System. Campbell BC, Mitchell PJ, Kleinig TJ, et al. !mqHfALY48 cexRM_ #6O{'_SAK5sUHGOnX-6Aw !664W@q '#qJi&qI Medtronic Data on File. As there are no known coronary stents made from ferromagnetic metallic materials, it is not necessary to wait 6 weeks or longer for MRI scanning. If you continue, you may go to a site run by someone else. Bench and animal testing may not be representative of actual clinical performance. For a GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placed within a bare nitinol stent, the lesser of the maximum whole-body averaged SAR reported in the bare nitinol stents Instructions for Use, or the maximum whole-body averaged SAR of 2.0 W/kg should be used. Among . ?\IY6u_lBP#T"42%J`_X MUOd This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. Therefore, Solitaire AB stentassisted coil embolization was demonstrated to be a safe and effective treatment for ruptured very small intracranial aneurysms. > nial stents and to assess the utility of performing gadolin-ium-enhanced MRA. The study will demonstrate safety and efficacy of the SOLITAIRE Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke. x]6}WjX|}Y<0<4dHwOgb-KV,R%>??(VjqX\.?6Zg3?yQU;CmS6T(o^vYzC5'!ucXSYk$'Ai]SFoO9m4U4]_5-C.6m5E@eTTy\KyG*=gXN| F1t)O}]}(?Z~_,-wky}7 )}-p}y-[JE'!+"{Q%iRMVqITPh>X~F\H[WDD |! Keywords. This library contains technical information on whether an MRI scan can be performed and how to perform a scan on patients with Medtronic implantable devices. by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: J. Med. 4 W/kg (first level controlled operating mode), 15 minutes of scanning (i.e., per pulse sequence), In non-clinical testing, the image artifact caused by the GORE, In non-clinical testing, the image artifact caused by the device extends approximately 5 mm from the GORE, Immediately after placement if conditions are met, 10 mm relative to the size and shape of the vascular device, 60 minutes of continuous RF (a sequence or back to back series/scan without breaks). Update my browser now. Materials and methods: From January 2011 through January 2016, we retrospectively selected 2979 patients with acute ischemic stroke. This site uses cookies to store information on your computer. AIS Revascularization Products stent dislodgment soon after left main coronary artery stenting. The SYNERGY&trade; XD Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries &ge;2.25 mm to &le;5.0 mm in diameter in . Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomized trials. "MR Conditional" stent graft treating a thoracic aneurysm (Courtesy Cook), To my knowledge, there are no currently implanted stents that are considered. The Solitaire X Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. With an updated browser, you will have a better Medtronic website experience. What should I do if I am undergoing an MRI scan? Do not treat patients with known stenosis proximal to the thrombus site. Advancement of the Solitaire X Revascularizaton Device against resistance may result in device damage and/or patient injury. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. The artifact may extend up to 10 mm from the implant. MRI-induced If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. MR:comp is the leading company for MR safety and MR compatibility testing of implants, instruments and medical devices. For best results, use Adobe Reader to view Medtronic manuals. The hemodynamic effect of a stenosis can be assessed via perfusion weighted MRI (PWI). TN Nguyen & Al. 4 0 obj Saver JL, Goyal M, Bonafe A, et al. Based on bench and animal testing results. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. Disclaimer: This page may include information about products that may not be available in your region or country. Our AIS portfolio offers comprehensive, compatible solutions that give your patients a better chance to walk away from AIS. Stroke; a journal of cerebral circulation. Mar 12 2015;372(11):1019-1030. A comprehensive portfolio for all AIS techniques. The XIENCE Skypoint, XIENCE Sierra and XIENCE Alpine Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. Endovascular therapy for ischemic stroke with perfusion-imaging selection. 1984;61(3):458-467. doi:10.3171/jns.1984.61.3.0458. 36746380_ Neuroimaging of Acute Ischemic Stroke Multimodal Imaging Approach for Acute Endovascular Therapy - Read online for free. Registration is quick and free. Your opinion matters to others - rate this device or add a comment. Do you need support for procedures? Do not reprocess or re-sterilize. The aim of this study was to understand the efficacy and safety of MT in elderly patients, many of whom may have baseline impairment. Use of the Solitaire X Revascularization Device is contraindicated under these circumstances. If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. Indications, Safety, and Warnings. The XIENCE V stent should not migrate in this MRI environment. Frequent questions. Do not torque the Solitaire X Revascularization Device. 2016;387(10029):1723-1731. Most heart valves and coronary artery stents currently on the market and implanted in patients can go safely through an MRI scanner, Dr. Flamm says. Since the present method of implantation is under a scleral flap, creating a great deal of friction, this study's findings confirm the safety of the Ex-PRESS with MRI testing.The findings also point to the safety of the device if placed directly under the conjunctiva, the originally proposed method of implantation. Contact Technical Support. If you consent, analytics cookies will also be used to improve your user experience. To be fair and balanced, there is a single controversial case report from 2013 (Parthasarathy H, Saeed O, Marcuzzi D, Cheema AN. . Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. - (00:00), NV AIS Solitaire X Animation More information (see more) Metabolic encephalophaties are by definition those disorder of the central nervous system that are not due primarily to structural abnormalities . Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X. Goyal M, Menon BK, van Zwam WH, et al. Lancet. 2022;53(2):e30-e32. A. zFOKW%:tLQ31PFb*F2h_V*AGT8o/B-~Yj3rw XyIRd!!gU9@ag}A{bk@QU3O +u"V L sI J. Med. Your use of the other site is subject to the terms of use and privacy statement on that site. 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, The distinctive, evenly spaced platinum markers enable, Maintains consistent cell size and structure over varying vessel diameters, Provides multiple planes of contact to integrate with the clot, even double layering in smaller vessels, Meaningful visibility with real-time visualization of the radiopaque markers, Evaluate clot composition through body marker integration into the clot, Visualize the expansion and compression of the stent to help. This stent can be safely scanned in an MR system meeting the following . Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Bench testing may not be representative of actual clinical performance. The MRI safety information is given on the Patient Implant Card. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. See our stroke products, from stent retrievers to aspiration systems. N. Engl. No device migration or heating was induced. The Solitaire X Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Solitaire AB Neurovascular Remodeling Deviceis designed for thetreatment of intracranial neurovascular disease. Patients with known hypersensitivity to nickel-titanium. For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire X Revascularization Devices. Circ Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The safety and efficacy of the Xact Carotid Stent System has not been demonstrated with embolic protection systems other than the Emboshield Embolic Protection System. Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus related topics: Ischemic Stroke U.S. FDA Resources Arms and Interventions Go to Outcome Measures Go to Categorised under: Less information (see less), Images courtesy of Dr. Alejandro Tomasello Weitz, Differentiated radial outward force promotes clot and vessel wall contact during retrieval with the optimal amount of radial force.10*, A large real-world patient cohort demonstrated a first pass effect (FPE) rate of 40.5% and a modified FPE (mFPE) rate of 58.9% across patients treated with the Solitaire device.14, A large real-world patient cohort demonstrated the following results with the Solitaire device.15, modified Rankin Scale (mRS) 02 at 90days, Symptomatic intercranial hemorrhage (sICH). The tables show the Gore devices that are labeled as MR conditional. Non-covered stents may be bare (metal only) or impregnated with a medication (so-called drug . The safety and effectiveness has not been established for the Solitaire X device to reduce disability in patients with the following: More distal occlusions in the anterior circulation. The best of both worlds: Combination therapy for ischemic stroke. using stent-retrievers has been proven to be a safe and effective treatment in acute ischemic stroke (AIS . _+'$@K8)Z3M2m#rb^U>K%J]}m?lu*au&lm1Kf!J/ hiTqpCJY9[HB5=m]d5X|h ^C`h8malAb :wiN. Stroke. For a full version of conditions, please see product Instructions for Use (IFU). J Neurosurg. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. WhichMedicalDevice is a FREE resource created by clinicians for clinicians. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris. Thrombectomy within 8 hours after symptom onset in ischemic stroke. Bolstered by the integration of a historic $50 billion acquisition, Medtronic garnered $28.8 billion in fiscal 2016 sales to surpass rival Johnson & Johnson for top industry billing and bragging rights. 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J. Med. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. The deviceis a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. Tomasello A. Garca-Tornel , Requena M, Rubiera M, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: An American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: Endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance, MRI safety and devices: an update and expert consensus, Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation, Metallic stents: Evaluation of MR imaging, Long-term safety of cardiac magnetic resonance imaging performed in the first few days after bare-metal stent implantation. . Goyal M, Demchuk AM, Menon BK, et al. Stroke. Stroke. 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. Pereira VM, Gralla J, Davalos A, et al. For device safety, do not use each Solitaire X Revascularization Device for more than three flow restoration recoveries. Some cookies are strictly necessary to allow this site to function. #vDq2wXbO/D"Od_n00|IV+iZ7D{?Q`8'D1[1^-_S=8rTWZw5SD@n&M66;,AU5 7b ; a+;VAC=` "340pfgv~y?/SOU8dt)&k,S^_*5DSn}(N YVbwcKxNIL|.h~v%Wv-?.\qd wMF{AgeBU*^x@OqVnET.I|a,vv0gF38lN2J}A. The Use of Solitaire AB Stents in Coil Embolization of Wide-Necked Cerebral Aneurysms. Subscribe to our newsletter. Zaidat OO, Castonguay AC, Linfante I, et al. The Neuroform (Boston Scientific Corporation, Natick, MA) stent is a self-expanding nitinol stent designed to assist the endovascular placement of detachable coils in wide-necked intracranial aneurysms ( 1, 2 ). Click OK to confirm you are a Healthcare Professional. The purpose of this study was to . MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Magnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional The tables show the Gore devices that are labeled as MR conditional. %PDF-1.3 (17) Sommer T, et al. They are typically inserted during a procedure called. Flottmann F, Leischner H, Broocks G, et al. The Solitaire X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. When the GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface was placed within a bare nitinol stent the image artifact extended up to 20 mm from the devices. Stroke. Medical Information Search Artifacts extended both inside and outside the device lumen. Jan 1 2015;372(1):11-20. Contact Medtronic | Terms of Use | Privacy Statement | Medtronic Manual Library | Choose Region, (such as 9528, 3875-45, 305U219, ENSP30030W), (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim), (such as pacemaker, stent, otology implants, drug pump), All conditions for use for all implanted devices, The associated risks for a patient with these devices. Stents (non covered ). Carry the Patient Implant Card with you at all times and show it to any medical professional who treats you. Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. Clot Retrieval Thrombectomy for Acute Ischemic Stroke, Central/Eastern Europe, Middle East & Africa, Acute Ischemic Stroke Revascularisation Products, Access & Delivery Products for Neurovascular, Unique parametric design for dynamic clot integration, Complete visualisation and coverage from M2 to ICA, Optimised delivery system produces lower delivery force, Maintaining consistent stent cell size and structure, Providing multiple planes of clot integration contact, Length from Distal Tip to Flurorosafe marker: <130cm. 2020 Jun;51(6):e118]. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. The patient's wallet card specifies the model number. Please consult the approved indications for use. 2016; 15: 113847. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. Learn more about navigating our updated article layout. CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. Stents are widely used throughout the entire arterial system, ranging from vessels several centimeters across (like the thoracic aorta) down to vessels only a few millimeters in diameter (like coronary and intracranial arteries). In a multinational cohort of 1,604 patients presenting with LVO in the extended window, patients selected by NCCT had comparable clinical and safety outcomes with patients selected by CTP or MRI . Adverse reaction to antiplatelet/ anticoagulation agents or contrast media, Device(s) deformation, collapse, fracture or malfunction, Distal embolization including to a previously uninvolved territory, Neurologic deterioration including stroke progression, stroke in new vascular territory, and death, The risk of complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia) increases as the procedure time and the number of procedures increase, User experiences major dissatisfaction with device performance. NV AIS Solitaire X Animation We've kept the same highly effective Trevo stent, designed to reduce disability in patients experiencing acute ischemic stroke (AIS) up to 24 hours from time last seen well by removing clots to . SUMMARY: The balloon remodeling technique was initially designed for the endovascular treatment of anatomically complex aneurysms, specifically wide-neck aneurysms. You just clicked a link to go to another website. Update my browser now. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. Registration is free and gives you unlimited access to all of the content and features of this website. The information on this page is current as of November 2022. 2014;45:141-145. The information from the scan may help your doctor decide if you need another stent. More information (see more) N. Engl. Usable length that is at least as long as the length of the thrombus. 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. Mar 12 2015;372(11):1009-1018. 15 minutes of scanning (i.e. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Is there an increased risk of IVC filters moving during MRI? 2019;50(7):1781-1788. Jadhav AP, Desai SM, Zaidat OO, et al. The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. For access to the full library of product manuals, visit the Medtronic Manual Library. Neurological With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. The information on this page provides only a summary of MR conditions for each device and is intended as a reference for the U.S. only. Stents: Evaluation of MRI safety. % This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Cardiovasc Interv. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. Atherosclerosis, Endovascular, Enterprise, Intracranial stenosis, Stent . Lancet Neurol. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. FPE defined as mTICI2c/3; modified FPE defined as mTICI 2b-3. Update my browser now. 5.2 (MISE JOUR DE 2022) Administration de la thrombolyse intraveineuse La thrombolyse intraveineuse doit tre offerte tous les patients ayant subi un AVC ischmique invalidant qui sont admissibles l'altplase ou la tnectplase dans les 4,5 heures suivant l'apparition des symptmes ou partir du dernier moment o ils ont t vus en bonne sant (recommandation forte . This MRI Resource Library is filtered to provide MRI-specific information. Since that time, several papers have been published demonstrating the safety of scanning patients immediately after stent placement; so that is the protocol I follow and recommend. We performed the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME) trial to establish the efficacy and safety of rapid neurovascular thrombectomy. Campbell BC, Hill MD, Rubiera M, et al. The Orsiro Mission stent is MR conditional. Purpose Stent retrievers apply mechanical force to the intracranial vasculature. Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com NOTE: A patient may have more than one implanted device. 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. stream If excessive resistance is encountered during the delivery of the Solitaire X Revascularization Device, discontinue the delivery and identify the cause of the resistance. Healthcare Professionals Did you know you can Register for FREE with this website? The Solitaire X portfolio is designed to give you greater confidence during interventional stroke procedures with: SolitaireTM X Revascularization Device View the features and simulated use of the SolitaireTM X device A total of 19 patients having under-gone intracranial stenting for aneurysms were imaged by MRI at 1.5T. This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. Jun 11 2015;372(24):2285-2295. Indications, Safety and Warnings IFU Oct 2013;44(10):2802-2807. . Less information (see less). 2022 The Regents of the University of California | Accessibility | Terms of Use | Privacy Policy, (T32) Biomedical Imaging for Clinician Scientists. Patients with angiographic evidence of carotid dissection. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy Jun 11 2015;372(24):2296-2306. Stents are basically small tubes or sometimes springs that help prop arteries open. J. Med. Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. The safety of MRI within 24 hours of stent implantation has not been formally studied. RX Only. 2013;6:e58e59) wherein a very short left main coronary stent perched at the ostium was found displaced to an iliac artery after a 1.5T MRI was performed 10 days after placement. Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use. Do not cause delays in this therapy. The longterm efficacy of this technique may be improved by increasing the packing density around the aneurysmal neck and improving the hemodynamics. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. Stroke. Do not recover (i.e. Do not use kinked or damaged components. A randomized trial of intraarterial treatment for acute ischemic stroke.