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. A. For a full version of conditions, please see product Instructions for Use (IFU). Randomized assessment of rapid endovascular treatment of ischemic stroke. &dR~% '7) W P2yob)eRUX@F&oE+7" % It is delivered througha standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Campbell BC, Mitchell PJ, Kleinig TJ, et al. F= Z1SWb-h{1-9mJqc52u[(Mk[){g~,YJmnixZq:aNPWj/N4j Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris. The aim of this procedure is to ensure that a stent is in the correct place and that it is not blocking the drainage of bile. This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. > Initiate mechanical thrombectomy treatment as soon as possible. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Among . Precautions Inspect the product prior to use. See Table XXI in online Data Supplement 1 Downloaded from Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The Orsiro Mission stent is MR conditional. What should I do if I am undergoing an MRI scan? Reasons for Reperfusion Failures in Stent-Retriever-Based Thrombectomy: Registry Analysis and Proposal of a Classification System 2017;48(10):2760-2768. Registration is free and gives you unlimited access to all of the content and features of Which Medical 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. 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. If you continue, you may go to a site run by someone else. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. The information from the scan may help your doctor decide if you need another stent. 2014;45:141-145. 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 |! Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. 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 ). 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. Solitaire X - AIS Revascularization Products | Medtronic Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. Feasibility of Permanent Stenting with Solitaire FR as a Rescue Flottmann F, Leischner H, Broocks G, et al. Indications, Safety and Warnings IFU 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Biliary stents MRI safety - All your info about health and medicine They are typically inserted during a procedure called. 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. Garca-Tornel , Requena M, Rubiera M, et al. Indications, Safety, and Warnings. RESULTS: All except two types of stents showed minimal ferromagnetism. Background The number of elderly patients suffering from ischemic stroke is rising. The presence of this implant may produce an image artifact. The role of MRI in the central nervous system (pdf) | Paperity 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. J. Med. Therefore, Solitaire AB stentassisted coil embolization was demonstrated to be a safe and effective treatment for ruptured very small intracranial aneurysms. Maximum 15 min of scanning (per sequence). See how stroke treatment with the SolitaireTM device provides economic value in UK. Indications, Safety and Warnings - Boston Scientific 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. Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. J. Med. 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). Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. No device migration or heating was induced. Intracranial thrombectomy using the Solitaire stent: a historical Goyal M, Menon BK, van Zwam WH, et al. MR Safety and Imaging of Neuroform Stents at 3T Solitaire X. 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. 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 . 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. Mechanical Thrombectomy in Elderly Stroke Patients with Mild-to 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. 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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. Methods: From the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register, we included consecutive acute ischemic stroke patients (2015-2021) treated within 4.5. Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. The aim of this study was to understand the efficacy and safety of MT in elderly patients, many of whom may have baseline impairment. Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use. 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. For best results, use Adobe Reader to view Medtronic manuals. Products The safety of MRI within 24 hours of stent implantation has not been formally studied. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2 zFOKW%:tLQ31PFb*F2h_V*AGT8o/B-~Yj3rw XyIRd!!gU9@ag}A{bk@QU3O +u"V L sI Usable length that is at least as long as the length of the thrombus. THE List - mrisafety.com Am J Roentgenol 1999;173:543-546. Stents are basically small tubes or sometimes springs that help prop arteries open. Bench and animal testing may not be representative of actual clinical performance. Update my browser now. Your opinion matters to others - rate this device or add a comment. . Materials and methods: From January 2011 through January 2016, we retrospectively selected 2979 patients with acute ischemic stroke. Some cookies are strictly necessary to allow this site to function. Solitaire X Revascularization Device does not allow for electrolytic detachment. It can be scanned safely under the conditions listed in the Instructions . ?\IY6u_lBP#T"42%J`_X MUOd 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. 2016; 15: 113847. SOLITAIRE FR With the Intention For Thrombectomy (SWIFT) Study - Full 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. 2016;387(10029):1723-1731. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. Campbell BC, Hill MD, Rubiera M, et al. 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. #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. First pass effect: A new measure for stroke thrombectomy devices. For a compatible microcatheter to help you smoothly navigate through even the most complicated anatomy, choose from the Phenom 21 or 27 catheter to deliver the Solitaire X device. Pereira VM, Gralla J, Davalos A, et al. Avoid unnecessary handling, which may kink or damage the Delivery System. Registration is free and gives you unlimited access to all of the content and features of this website. Jadhav AP, Desai SM, Zaidat OO, et al. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content. The longterm efficacy of this technique may be improved by increasing the packing density around the aneurysmal neck and improving the hemodynamics. Atherosclerosis, Endovascular, Enterprise, Intracranial stenosis, Stent . Mar 12 2015;372(11):1019-1030. Please help keep this site free for everyone in the world! 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 you need support for procedures? . Solitaire AB stent (6 mm 30 mm) assisting complete occlusion in one More information (see more) Treatment of ischemic stroke among patients with occlusion. Medical More information (see more) 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. 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. Endovascular therapy with the device should be started within 6 hours of symptom onset. Cardiac stents are small, metal mesh tubes that are inserted into narrowed or blocked coronary arteries to improve blood flow to the heart. See Table XXI in online Data Supplement 1 Downloaded from httpahajournalsorg by from MNGMT 123 at University of Virginia If the product name you seek is not listed, try looking for information by device type. Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. 1,2 The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. Jovin TG, Chamorro A, Cobo E, et al. Based on smallest vessel diameter at thrombus site. With an updated browser, you will have a better Medtronic website experience. This is a condition called restenosis. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com Comparison of a direct aspiration first pass technique vs. stent Markus MHLENBRUCH | Senior Consultant | Doctor of Medicine Microsurgical anatomy of the proximal segments of the middle cerebral artery. The XIENCE Skypoint, XIENCE Sierra and XIENCE Alpine Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. TN Nguyen & Al. Coronary Arterial Stents: Safety and Artifacts during MR Imaging Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Enterprise stent for the treatment of symptomatic intracranial It is possible that some of the products on the other site are not approved in your region or country. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. For each new Solitaire X Revascularization Device, use a new microcatheter. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Open-cell stent and use of cone-beam CT enables a safe and effective Intracranial Aneurysm Stenting: Follow-Up With MR Angiography J. Med. Categorised under: Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Frequent questions. Read MR Safety Disclaimer Before Proceeding. 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. Medtronic Data on File. 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. Jun 11 2015;372(24):2285-2295. 2016;47(3):798-806. The Solitaire X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients. A total of 20 stents were placed in 19 patients. See our stroke products, from stent retrievers to aspiration systems. 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 . 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 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, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). AIS Revascularization Products - Solitaire X | Medtronic AIS Revascularization Products Case report: 63 year old female present pulsatile headache, diplopia, III. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. Berkhemer OA, Fransen PS, Beumer D, et al. Update my browser now. Solitaire AB stentassisted coiling embolization for the treatment of Solitaire X Solitaire X is a new generation revascularisation device with a unique parametric design, featuring an overlapping technology, providing physicians with improved delivery performance, effective clot retention and faster flow restoration timelines, designed to be deployed with a lower microcatheter profile, to provide expanded ease of delivery. If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. Do not use kinked or damaged components. THE List - MRI Safety Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. 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. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. Artifacts extended both inside and outside the device lumen. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Please consult the approved indications for use. 1984;61(3):458-467. doi:10.3171/jns.1984.61.3.0458. Find out more Keep up to date Few data are available for comparing the therapeutic effects associated with the two mechanical thrombectomy techniques in acute ischemic stroke with atrial fibrillation. The distinctive, evenly-spaced platinum markers let you visualise the optimal working length and stent behavior for real-time procedural feedback, ensuring accurate alignment, optimal revascularisation, and clot capture success.2, The 6x40 length device simplifies placement with proximal ophthalmic alignment, providing complete visualisation and coverage from M2 to ICA.4,6, Our SolitaireTM portfolio is backed by published data with 11+ trials and case studies worldwide, proving it reduces stroke-related disability in patients suffering a large vessel acute ischemic stroke following IV t-PA.9-19. RX Only. MRI exams are safe for some devices. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. B. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. EV3 | Solitaire AB - Which Medical Device 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 drug is slowly released to help keep the blood vessel from narrowing again.
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