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. The Solitaire X Revascularization Device is not to be used after the expiration date imprinted on the product label. Serge Bracard, Xavier Ducrocq, et al. Saver JL, Goyal M, Bonafe A, et al. If a stent is put into a patient's bile duct during an MRI, it will not be visible. 1,2 The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. 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). More information (see more) For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size. The MRI safety information is given on the Patient Implant Card. 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. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Update my browser now. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Atherosclerosis, Endovascular, Enterprise, Intracranial stenosis, Stent . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. nial stents and to assess the utility of performing gadolin-ium-enhanced MRA. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. Initiate mechanical thrombectomy treatment as soon as possible. N. Engl. Home stenting of symptomatic middle cerebral artery stenosis and perioperative evaluation using high-resolution 3 Tesla MRI (2012 . Pereira VM, Gralla J, Davalos A, et al. Registration is quick and free. If excessive resistance is encountered during recovery of the Solitaire X Revascularization Device, discontinue the recovery and identify the cause of the resistance. This MRI Resource Library is filtered to provide MRI-specific information. Endovascular therapy with the device should be started within 6 hours of symptom onset. Bench and animal testing may not be representative of actual clinical performance. 2014;45:141-145. Balloon Guide Catheter Improves Revascularization and Clinical Outcomes With the Solitaire Device. Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. 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 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 . 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. More information (see more) 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 Data on File. Vascular You can read our Privacy Policy here. pull back) the device when encountering excessive resistance. For device safety, do not use each Solitaire X Revascularization Device for more than three flow restoration recoveries. using stent-retrievers has been proven to be a safe and effective treatment in acute ischemic stroke (AIS . 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. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. Stroke. 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. 4 0 obj The XIENCE Skypoint, XIENCE Sierra and XIENCE Alpine Stent Systems are coated with an everolimus and polymer coating at the full implant stent length. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. 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. 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. 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. 2019;50(7):1781-1788. Products This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. With an updated browser, you will have a better Medtronic website experience. 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. Reasons for Reperfusion Failures in Stent-Retriever-Based Thrombectomy: Registry Analysis and Proposal of a Classification System Solitaire Literature Review Aug2022. A comprehensive portfolio for all AIS techniques. Zaidat OO, Castonguay AC, Linfante I, et al. Do not treat patients with known stenosis proximal to the thrombus site. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2 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. Solitaire X Revascularization Device does not allow for electrolytic detachment. Based on smallest vessel diameter at thrombus site. Stroke. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com Mar 12 2015;372(11):1009-1018. Is there an increased risk of IVC filters moving during MRI? Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. Patients with angiographic evidence of carotid dissection. Materials and methods: From January 2011 through January 2016, we retrospectively selected 2979 patients with acute ischemic stroke. Reports from device programmers include references to the model number: Product Name search includes brand or trademark names for many Medtronic products; however, not all products are included. The tables show the Gore devices that are labeled as MR conditional. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. TN Nguyen & Al. Jun 11 2015;372(24):2296-2306. 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 information from the scan may help your doctor decide if you need another stent. Did you know you can Register for FREE with this website? 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. Do not use kinked or damaged components. If you continue, you may go to a site run by someone else. 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. 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! Less information (see less). 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. - (00:00), NV AIS Solitaire X Animation Please consult the approved indications for use. 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. More information (see more) The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. The powerful magnetic field of the MRI scanner may damage internal metal devices, such as a heart pacemaker. Recanalization rate per retrieval attempt in mechanical thrombectomy for acute ischemic stroke. 2018;49(10):2523-2525. Stents are basically small tubes or sometimes springs that help prop arteries open. This is a condition called restenosis. Artifacts extended both inside and outside the device lumen. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomized trials. 2020 Jun;51(6):e118]. Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry.