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This stent can be safely scanned in an MR system meeting the following . Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. % The Solitaire X Revascularization Device is not to be used after the expiration date imprinted on the product label. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Brand Name: Solitaire X Version or Model: SFR4-3-20-10 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: Micro Therapeutics, Inc. Primary DI Number: 00763000367619 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 826110710 * Terms of Use Garca-Tornel , Requena M, Rubiera M, et al. If excessive resistance is encountered during recovery of the Solitaire X Revascularization Device, discontinue the recovery and identify the cause of the resistance. Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. The purpose of this study was to . Do not use kinked or damaged components. If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. using stent-retrievers has been proven to be a safe and effective treatment in acute ischemic stroke (AIS . 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). NOTE: A patient may have more than one implanted device. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. 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. 1984;61(3):458-467. doi:10.3171/jns.1984.61.3.0458. MR:comp is the leading company for MR safety and MR compatibility testing of implants, instruments and medical devices. 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. _+'$@K8)Z3M2m#rb^U>K%J]}m?lu*au&lm1Kf!J/ hiTqpCJY9[HB5=m]d5X|h ^C`h8malAb :wiN. 2016;387(10029):1723-1731. Apr 23 2016;387(10029):1723-1731. Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. Use of the Solitaire X Revascularization Device is contraindicated under these circumstances. J Neurosurg. Contact Technical Support. 4 0 obj 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 . Background The number of elderly patients suffering from ischemic stroke is rising. 2016;47(3):798-806. With an updated browser, you will have a better Medtronic website experience. Methods: Solitaire AB stents were placed during angioplasty and stenting of MCA and BA stenoses in patients at our department between January 2015 and May 2017 with 6-36 months follow-up. 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. Read MR Safety Disclaimer Before Proceeding. 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. Is it safe to have MRI with heart stents? Stroke. Update my browser now. This device is supplied STERILE for single use only. The Orsiro Mission stent is MR conditional. Stroke. More information (see more) 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. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. Based on bench and animal testing results. Our AIS portfolio offers comprehensive, compatible solutions that give your patients a better chance to walk away from AIS. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 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). &dR~% '7) W P2yob)eRUX@F&oE+7" % Healthcare Professionals Click OK to confirm you are a Healthcare Professional. J. Med. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 2018;49(10):2523-2525. Endovascular therapy with the device should be started within 6 hours of symptom onset. Initiate mechanical thrombectomy treatment as soon as possible. Your use of the other site is subject to the terms of use and privacy statement on that site. 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). 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. Registration is quick and free. Read robust data about the safety and efficacy of the Solitaire revascularization device. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. 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. Do not use if the package is open or damaged. For a full version of conditions, please see product Instructions for Use (IFU). Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. MRI exams are safe for some devices. nial stents and to assess the utility of performing gadolin-ium-enhanced MRA. 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. Do not torque the Solitaire X Revascularization Device. Lancet. . Jun 11 2015;372(24):2285-2295. Products See Table XXI in online Data Supplement 1 Downloaded from httpahajournalsorg by from MNGMT 123 at University of Virginia Medtronic creates meaningful technologies to empower AIS physicians. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. RX Only. Disclaimer: This page may include information about products that may not be available in your region or country. Atherosclerosis, Endovascular, Enterprise, Intracranial stenosis, Stent . With an updated browser, you will have a better Medtronic website experience. Do not recover (i.e. Registration gives you full access to all of the features of WhichMedicalDevice. Home 2017;48(10):2760-2768. Home The device is a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. A total of 20 stents were placed in 19 patients. 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. 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. Flottmann F, Leischner H, Broocks G, et al. This site uses cookies to store information on your computer. It is delivered througha standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. The XIENCE Skypoint, XIENCE Sierra and XIENCE Alpine Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset (IV t-PA use beyond 3 hours is not approved in the United States). Do not cause delays in this therapy. Randomized trials of mechanical thrombectomy (MT) generally exclude patients over the age of 80 years with baseline disability. It is delivered through a standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. Campbell BC, Mitchell PJ, Kleinig TJ, et al. Neurological N. Engl. Solitaire X. Judicious selection of patients is necessary, since the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.