The Solitaire X Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (<70 cc by CTA or MRA, <25 cc by MR-DWI). Cardiovasc Interv. The information from the scan may help your doctor decide if you need another stent. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. Metabolic encephalophaties are by definition those disorder of the central nervous system that are not due primarily to structural abnormalities . The risk of clot migration into arteries downstream during the procedure is also a concern, as it may complicate reperfusion and increase the possibility of neurological impairment.11-13 The regimen for isolated ICA with EVT is ambiguous, and the therapeutic efficacy needs further examination. 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. The XIENCE Skypoint, XIENCE Sierra and XIENCE Alpine Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. Keywords. When to Stop [published correction appears in Stroke. Magnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional The tables show the Gore devices that are labeled as MR conditional. The "conditions" associated with some stents recommend that whole-body-averaged SAR levels not exceed 2 W/kg and a maximum of 15 minutes per sequences, while other stents permit up to 4 W/kg. The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. 2014;45:141-145. The overlapping stent design allows the device to expand in larger vessels and compress in smaller vessels during deployment and retrieval3 as well as: Our Solitaire X revascularisation device - designed with an optimised delivery system - produces lower delivery force7 for improved procedural efficiency and smooth navigation through even the most complicated anatomy. Home Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: Failure to comply with the conditions for use can cause damage to the implanted devices or serious injury to the patient, including death. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Solo MicroPumpInsulin PumpMedingo US, Inc.www.Medingo.com, Solo Smart Heart Valve ProsthesisSorin Group, www.sorin.com, Solo Tympanostomy Tube Device Ventilation Tube Otologic implant High Density Polyethylene (HDPE) AventaMed,www.aventamed.com, Solo+ Tympanostomy Tube Device (TTD) Ventilation Tube, Solus Anterior Lumbar Interbody Fusion (ALIF)Alphatec Spine Inc., www.alphatecspine.com, Solus Double Pigtail StentCook Medical, Inc.www.cookmedical.com, Solyx SIS(Single Incision Sling) SystemBoston Scientific CorporationMarlborough, MA, SOPH-A-PORT Mini Spinal Implantable Access PortSophysa, www.sophysa.com, SOPHY Adjustable Pressure Valve Sophysa USA, Inc. www.sophysa.com, Sophy programmable pressure valveModel SM8misc.SophysaOrsay, France, Sophy programmable pressure valveModel SM8SophysaOrsay, France, Sophy programmable pressure valveModel SP3misc.SophysaOrsay, France, Sophy programmable pressure valveModel SU8SophysaOrsay, France, Sophysa SOPH-A-PORT Mini SImplantable Access PortShire, www.shire.com, Soprano Armonia Heart Valve ProsthesisSorin Group, www.sorin.com, Sorin Allcarbon, ASModel MTR-29AS, 29 mmpyrolitic carbonHeart ValveSorin Biomedica Cardio S.p.A.Saluggia, Italy. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. What do you do about tracheobronchial airway devices like stents, valves and coils. WhichMedicalDevice is a FREE resource created by clinicians for clinicians. This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of notified bodies. The permanent stent acts like a scaffold for the artery. Initiate mechanical thrombectomy treatment as soon as possible. How about other GU devices like nephrostomy tubes and stents? A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. 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). 4 0 obj Avoid unnecessary handling, which may kink or damage the Delivery System. Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. Among . 2018;49(3):660-666. _+'$@K8)Z3M2m#rb^U>K%J]}m?lu*au&lm1Kf!J/ hiTqpCJY9[HB5=m]d5X|h ^C`h8malAb :wiN. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. Methods Between January 2015 and April 2017, 96 . Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible. %PDF-1.3 Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. SUMMARY: The balloon remodeling technique was initially designed for the endovascular treatment of anatomically complex aneurysms, specifically wide-neck aneurysms. Safety of Intra-Arterial Tirofiban Administration in Ischemic Stroke Patients after Unsuccessful Mechanical Thrombectomy . Less information (see less). Stroke. Based on smallest vessel diameter at thrombus site. This was the first successful human clinical use of a Solitaire stent for this purpose and the ignition spark for the development of a whole generation of new devices, now called stent . 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. Do not advance the microcatheter against any resistance. Our aim was to assess the feasibility and safety of permanent stent placement with the Solitaire FR compared with other self-expanding stents for intracranial artery recanalization for acute ischemic stroke. 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. 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. Our aim was to evaluate the safety and efficacy of the long Solitaire 4 40 mm stent retriever for large vessel occlusion in stroke patients. The hemodynamic effect of a stenosis can be assessed via perfusion weighted MRI (PWI). Healthcare Professionals Jun 11 2015;372(24):2285-2295. Read our cookie policy to learn more including how you may change your settings. Learn more about navigating our updated article layout. The presence of this implant may produce an image artifact. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. > 2016; 15: 113847. Our team is happy to help answer any questions you may have. Do not recover (i.e. With an updated browser, you will have a better Medtronic website experience. Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. See how stroke treatment with the SolitaireTM device provides economic value in UK. Find out more Keep up to date Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. The Use of Solitaire AB Stents in Coil Embolization of Wide-Necked Cerebral Aneurysms. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. J. Med. Therefore, Solitaire AB stentassisted coil embolization was demonstrated to be a safe and effective treatment for ruptured very small intracranial aneurysms. Registration is free and gives you unlimited access to all of the content and features of this website. Umansky F, Juarez SM, Dujovny M, et al. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com The best of both worlds: Combination therapy for ischemic stroke. Interventional Radiology Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. For access to the full library of product manuals, visit the Medtronic Manual Library. The safety of MRI within 24 hours of stent implantation has not been formally studied. ?\IY6u_lBP#T"42%J`_X MUOd Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. A. The powerful magnetic field of the MRI scanner may damage internal metal devices, such as a heart pacemaker. Products 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. Frequent questions. Tomasello A. Medtronic creates meaningful technologies to empower AIS physicians. > 1984;61(3):458-467. doi:10.3171/jns.1984.61.3.0458. Read MR Safety Disclaimer Before Proceeding. Stroke. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content. Registration is quick and free. Update my browser now. The longterm efficacy of this technique may be improved by increasing the packing density around the aneurysmal neck and improving the hemodynamics. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Visi-pro balloon expandable vascular and biliary stent, SUPERA Veritas Self-Expanding Nitinol Stent, Maris Deep Infrapopliteal Self-Expanding Stent, Chromis Deep Infrapopliteal Balloon-Expandable Stent, Tsunami Peripheral Balloon-expandable Stent, Continuous Renal Replacement Therapy (CRRT), Percutaneous Ventricular Restoration Therapy. "MR Conditional" stent graft treating a thoracic aneurysm (Courtesy Cook), To my knowledge, there are no currently implanted stents that are considered. Precautions Inspect the product prior to use. Indications, Safety and Warnings IFU Solitaire X Cardiac stents are small, metal mesh tubes that are inserted into narrowed or blocked coronary arteries to improve blood flow to the heart. The Solitaire X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients. NOTE: A patient may have more than one implanted device. The deviceis a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. stream Stents (non covered ). Medtronic Data on File. Based on bench testing results. If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Please help keep this site free for everyone in the world! 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. Lancet. Stroke; a journal of cerebral circulation. 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. Under these conditions, the central portion of the lumen of the aortic component was visible. Methods We conducted a retrospective analysis of all patients treated for acute ischemic large vessel occlusion stroke with the Solitaire 2 FR 4 40 device between May . A randomized trial of intraarterial treatment for acute ischemic stroke. Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. !mqHfALY48 cexRM_ #6O{'_SAK5sUHGOnX-6Aw !664W@q '#qJi&qI 2020 Jun;51(6):e118]. This site uses cookies to store information on your computer. First pass effect: A new measure for stroke thrombectomy devices. Endovascular therapy with the device should be started within 6 hours of symptom onset. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. This device is supplied STERILE for single use only. 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: Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use. Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X. Goyal M, Menon BK, van Zwam WH, et al. The aim of this study was to understand the efficacy and safety of MT in elderly patients, many of whom may have baseline impairment. STRATIS, SWIFT PRIME, ESCAPE, Nasa Registry, THRACE, MR CLEAN, STAR, EXTEND IA, HERMES, SEER, REVASCAT, DEFUSE 3, Note: The Solitaire X Revascularization Device was not evaluated in these studies. Bench testing may not be representative of actual clinical performance. Microsurgical anatomy of the proximal segments of the middle cerebral artery. Carry the Patient Implant Card with you at all times and show it to any medical professional who treats you. Berkhemer OA, Fransen PS, Beumer D, et al. J. Med. Do not cause delays in this therapy. N. Engl. Although the authors blamed the MRI for the displacement, subsequent letters to the editor cast doubt on this assertion, providing evidence that the original stent was poorly chosen and placed and that spontaneous displacement of similarly placed stents had been reported in the absence of MRI. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Apr 23 2016;387(10029):1723-1731. Products What should I do if I am undergoing an MRI scan? A total of 20 stents were placed in 19 patients. Date of coronary stent placement and device manufacturer should be documented prior to MRI. MRI Information. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. It is delivered througha standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. Endovascular therapy for ischemic stroke with perfusion-imaging selection. 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. 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 . Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. With an updated browser, you will have a better Medtronic website experience. Solitaire X. Jan 1 2015;372(1):11-20. You just clicked a link to go to another website. . Randomized assessment of rapid endovascular treatment of ischemic stroke. 2022;53(2):e30-e32. Slot Screwdriver3*50-mmNewmatic Medical, www.newmaticmedical.com, Small External FixatorExternal Fixation Systemcarbon composite, Titanium alloy, aluminum, SSBiomet, Inc., www.biomet.com, Small External FixatorExternal Fixation SystemDepuy Synthes, www.depuysynthes.com, SMart De La Cruz PistonOtologic ImplantNitinol/FluoroplasticGyrus ACMI (Olympus Medical), www.medical.olympusamerica.com, SMart Malleus PistonOtologic ImplantNitinol/FluoroplasticGyrus ACMI (Olympus Medical), www.medical.olympusamerica.com, SMart PistonOtologic ImplantFluoroplastic/NitinolGyrus ACMI (Olympus Medical), www.medical.olympusamerica.com, Smart Port CT-Injectable Portvascular access portAngioDynamicswww.angiodynamics.com, Smart Port(s), Vascular Access PortAngiodynamics, Inc., www.Angiodynamics.com, SmartGuide CT/MRIMRI Devices CorporationWaukesha, WI, Smelloff CutterAortictitaniumheart valveSorin BiomedicaItaly, Smeloff-CutterHeart ValveCutter Laboratories, Berkeley, CA, Snowshoe Suture Anchor PairUSGI Medical, Inc., www.usgimedical.com, Socket Preservation ScrewMedtronic, www.medtronic.com, Sof-Curl Ureteral StentPolyurethaneGyrus ACMI, Inc.Maple Grove, M, Soft Lift Treatment of Urinary Stress IncontinenceCousin Biotech, www.cousin-biotech.com, Soft Tissue Biopsy Needle Gun & biopsy needle (304 SS)Anchor Procducts Co.Addison, IL, Solanas Posterior Cervico-Thoracic Fixation SystemAlphatec Spine Inc., www.alphatecspine.com, Solex Intravascular Heat Exchange Catheter (Model SL-2593/8700-0671-01)Zoll Circulation, www.zoll.com, SOLITAIRE AB Neurovascular Remodeling DeviceCovidien and ev3 Inc., www.ev3.net, Solitaire Flow Restoration StentNitinol, SS, PlatinumCovidien and ev3 Inc., www.ev3.net. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices, Ocular Implants, Lens Implants, and Devices, Cardiovascular Catheters, Other Catheters, and Accessories, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories. Is there an increased risk of IVC filters moving during MRI? It is possible that some of the products on the other site are not approved in your region or country. Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. MR:comp is the leading company for MR safety and MR compatibility testing of implants, instruments and medical devices. Saver JL, Goyal M, Bonafe A, et al. Purpose Stent retrievers apply mechanical force to the intracranial vasculature. For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size. Mar 12 2015;372(11):1009-1018. Mar 12 2015;372(11):1019-1030. A comprehensive portfolio for all AIS techniques. See our stroke products, from stent retrievers to aspiration systems. Bench and animal testing may not be representative of actual clinical performance. Conclusion The Solitaire stent was initially developed for the endovascular treatment of wide necked intracranial aneurysms but has been demonstrated to be safe and efficacious for intracranial thrombectomy. The Solitaire AB stent is a scaffold that do flow blood diversion and promotes the aneurysms exclusion by thrombosis. If you consent, analytics cookies will also be used to improve your user experience. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute 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. Drug-coated stents have been approved for use by the U.S. Food and Drug Administration (FDA). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 2017;48(10):2760-2768. 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. More information (see more) Solitaire X Revascularization Device does not allow for electrolytic detachment. Based on bench and animal testing results. treatment of ischemic stroke among patients with occlusion. This MRI Resource Library is filtered to provide MRI-specific information. Jovin TG, Chamorro A, Cobo E, et al. B. The information on this page is current as of November 2022. 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 Do you need support for procedures? Download the latest version, at no charge. This stent or similar devices also have a role in visceral/peripheral aneurysms where a scafold is needed across the neck of an aneurysm to allow coils to be placed safely within the sac without prolapse in to the native vessel eg wide necked aneurysms. The drug is slowly released to help keep the blood vessel from narrowing again. TN Nguyen & Al. Use of appropriate anticoagulant and/or antiplatelet therapy per standard of care is recommended for use with this stent system. 2022 The Regents of the University of California | Accessibility | Terms of Use | Privacy Policy, (T32) Biomedical Imaging for Clinician Scientists. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. A real-world observational study found that EVT may be safe and effective in patients with wake-up stroke and late-presenting stroke selected using . The artifact may extend up to 10 mm from the implant. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. Did you know you can Register for FREE with this website? The tables show the Gore devices that are labeled as MR conditional. Non-clinical testing has demonstrated that the Xact Carotid stent is MR Conditional. 2018;49(10):2523-2525. More information (see more) MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. For a full version of conditions, please see product Instructions for Use (IFU). Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. Your opinion matters to others - rate this device or add a comment. Contact Technical Support. Metallic stents may indeed undergo heating during RF-excitation, but this also does not seem to be a major problem even with overlapping stents or with big aortic stent-grafts, in part because flowing blood serves to diffuse away whatever heat is locally generated. Healthcare Professionals Some cookies are strictly necessary to allow this site to function. J. Med. The MRI safety information is given on the Patient Implant Card. Zaidat OO, Castonguay AC, Linfante I, et al. For device safety, do not use each Solitaire X Revascularization Device for more than three flow restoration recoveries. 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 . 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 . 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. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. Stroke. Do not use kinked or damaged components. This site is Exclusively Sponsored by BRACCO, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices, Cardiovascular Catheters, Other Catheters, and Accessories. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where each product is available. Please Enter the Model Number or Select the Valid Model Number From the List, Please Enter the Product Name or Select the Valid Product Name From the List. Is it safe to have MRI with heart stents? Stroke. stenting of symptomatic middle cerebral artery stenosis and perioperative evaluation using high-resolution 3 Tesla MRI (2012 . Possible complications include, but are not limited to the following: Disclaimer: This page may include information about products that may not be available in your region or country. Background The number of elderly patients suffering from ischemic stroke is rising. NV AIS Solitaire X Animation % GORE VIABIL Biliary Endoprosthesis/GORE VIABIL Short WireBiliary Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft, GORE TAG Thoracic Branch Endoprosthesis, GORE EXCLUDER Conformable AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis, GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN VBX Balloon Expandable Endoprosthesis, GORE VIATORR TIPS Endoprosthesis/GORE VIATORR TIPS Endoprosthesis with Controlled Expansion. Few data are available for comparing the therapeutic effects associated with the two mechanical thrombectomy techniques in acute ischemic stroke with atrial fibrillation. 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. This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. 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 ). Indications, Safety, and Warnings. N. Engl. If excessive resistance is encountered during recovery of the Solitaire X Revascularization Device, discontinue the recovery and identify the cause of the resistance. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. 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. Jadhav AP, Desai SM, Zaidat OO, et al. per pulse sequence). Some controversies regarding the safety of the technique were introduced by the recent publication of .