Did you know you can Register for FREE with this website? _+'$@K8)Z3M2m#rb^U>K%J]}m?lu*au&lm1Kf!J/ hiTqpCJY9[HB5=m]d5X|h ^C`h8malAb :wiN. Please help keep this site free for everyone in the world! 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 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 ). The Solitaire X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. We do not make your details available to any third parties nor do we send unsolicited emails to our members. Campbell BC, Mitchell PJ, Kleinig TJ, et al. The safety of MRI within 24 hours of stent implantation has not been formally studied. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire Device. You just clicked a link to go to another website. Includes Solitaire FR, Solitaire 2, Solitaire Platinum, Solitaire X. Goyal M, Menon BK, van Zwam WH, et al. Pereira VM, Gralla J, Davalos A, et al. 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 . . See our stroke products, from stent retrievers to aspiration systems. Safety of Intra-Arterial Tirofiban Administration in Ischemic Stroke Patients after Unsuccessful Mechanical Thrombectomy . Methods Between January 2015 and April 2017, 96 . The information from the scan may help your doctor decide if you need another stent. Less information (see less). Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. #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. 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 . See Table XXI in online Data Supplement 1 Downloaded from httpahajournalsorg by from MNGMT 123 at University of Virginia 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. Lancet. Our team is happy to help answer any questions you may have. 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. What should I do if I am undergoing an MRI scan? Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. B. Serge Bracard, Xavier Ducrocq, et al. 2016; 15: 113847. MRI Information. Recanalization rate per retrieval attempt in mechanical thrombectomy for acute ischemic stroke. The MRI safety information is given on the Patient Implant Card. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. For best results, use Adobe Reader to view Medtronic manuals. 15 minutes of scanning (i.e. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. 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. Lancet. Among . Solitaire AB Neurovascular Remodeling Deviceis designed for thetreatment of intracranial neurovascular disease. Do not recover (i.e. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy The SYNERGY™ 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 ≥2.25 mm to ≤5.0 mm in diameter in . Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. Apr 23 2016;387(10029):1723-1731. stenting of symptomatic middle cerebral artery stenosis and perioperative evaluation using high-resolution 3 Tesla MRI (2012 . 1984;61(3):458-467. doi:10.3171/jns.1984.61.3.0458. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Or information on our products and solutions? Drug-coated stents have been approved for use by the U.S. Food and Drug Administration (FDA). Do not use if the package is open or damaged. Medtronic Data on File. 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. TR-NV13807A, TR-NV15666A, D00419703A, D00324045A. Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. 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. 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. More information (see more) 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). 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. Jadhav AP, Desai SM, Zaidat OO, et al. Healthcare Professionals If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. Do you need support for procedures? Goyal M, Demchuk AM, Menon BK, et al. Home It was a crowning achievement, as transformative for the company as it was impressive in both size and scope. Read our cookie policy to learn more including how you may change your settings. Background The number of elderly patients suffering from ischemic stroke is rising. The information on this page is current as of November 2022. J. Med. If the product name you seek is not listed, try looking for information by device type. This site uses cookies to store information on your computer. The idea was that the stent needed time to "settle in" and become incorporated in the vessel wall before risking displacement by magnetic forces. > N. Engl. Few data are available for comparing the therapeutic effects associated with the two mechanical thrombectomy techniques in acute ischemic stroke with atrial fibrillation. Artifacts extended both inside and outside the device lumen. A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. Cardiac stents are small, metal mesh tubes that are inserted into narrowed or blocked coronary arteries to improve blood flow to the heart. For access to the full library of product manuals, visit the Medtronic Manual Library. This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. 2017;48(10):2760-2768. Initiate mechanical thrombectomy treatment as soon as possible. Tomasello A. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. In addition to conventional T2- and diffusion-weighted MRI, 3D time-of-ight MRA was performed before and after A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. It is possible that some of the products on the other site are not approved in your region or country. N. Engl. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. 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. Based on bench and animal testing results. Stroke. 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. This device is supplied STERILE for single use only. For a full version of conditions, please see product Instructions for Use (IFU). Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. Registration gives you full access to all of the features of WhichMedicalDevice. You can read our Privacy Policy here. 2016;47(3):798-806. CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Stroke. 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). Categorised under: 2020 Jun;51(6):e118]. With an updated browser, you will have a better Medtronic website experience. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. J. Med. &dR~% '7) W P2yob)eRUX@F&oE+7" % This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. Registration is free and gives you unlimited access to all of the content and features of this website. Endovascular therapy with the device should be started within 6 hours of symptom onset. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Read MR Safety Disclaimer Before Proceeding. The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. 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. Open-cell stent and use of cone-beam CT enables a safe and effective coil embolization of true ophthalmic artery and anterior choroidal artery aneurysms with preservation of parent vessel: Clinical and angiographic results - PMC The new PMC design is here! A randomized trial of intraarterial treatment for acute ischemic stroke. J. Med. For each new Solitaire X Revascularization Device, use a new microcatheter. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 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 The deviceis a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. 2016;387(10029):1723-1731. Bench testing may not be representative of actual clinical performance. Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. Medical Information Search Solitaire X Revascularization Device does not allow for electrolytic detachment. using stent-retrievers has been proven to be a safe and effective treatment in acute ischemic stroke (AIS . Update my browser now. TN Nguyen & Al. If you consent, analytics cookies will also be used to improve your user experience. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. Stroke; a journal of cerebral circulation. The study will demonstrate safety and efficacy of the SOLITAIRE Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke. Reasons for Reperfusion Failures in Stent-Retriever-Based Thrombectomy: Registry Analysis and Proposal of a Classification System Includes Solitaire FR, Solitaire 2. ?\IY6u_lBP#T"42%J`_X MUOd 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 . The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. Our AIS portfolio offers comprehensive, compatible solutions that give your patients a better chance to walk away from AIS. Some cookies are strictly necessary to allow this site to function. 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. F= Z1SWb-h{1-9mJqc52u[(Mk[){g~,YJmnixZq:aNPWj/N4j When to Stop [published correction appears in Stroke. NV AIS Solitaire X Animation NOTE: A patient may have more than one implanted device. 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Endovascular therapy for ischemic stroke with perfusion-imaging selection. Do not treat patients with known stenosis proximal to the thrombus site. ObjectivesThe stent retriever thrombectomy (SRT) and a direct aspiration first-pass technique (ADAPT) are the two main mechanical thrombectomy (MT) techniques for acute ischemic stroke. As recently as 10 years ago, the package inserts of many stents, especially uncovered coronary stents, carried a warning not to scan patients in the first 6 weeks unless absolutely necessary. Campbell BC, Hill MD, Rubiera M, et al. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. It is delivered through a standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. N. Engl. Lancet Neurol. 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. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. If you continue, you may go to a site run by someone else. 36746380_ Neuroimaging of Acute Ischemic Stroke Multimodal Imaging Approach for Acute Endovascular Therapy - Read online for free. 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 Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomized controlled trial. See how stroke treatment with the SolitaireTM device provides economic value in UK. Use of the Solitaire X Revascularization Device is contraindicated under these circumstances. The device is a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. 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. Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris. This is a condition called restenosis. %PDF-1.3 More information (see more)
