solitaire stent mri safety

Do not reprocess or re-sterilize. First pass effect: A new measure for stroke thrombectomy devices. A stent crimping technology, which provides excellent stent retention and provides smooth surface transition across the stent and delivery system. 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. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. The hemodynamic effect of a stenosis can be assessed via perfusion weighted MRI (PWI). 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. 2016;47(3):798-806. 15 minutes of scanning (i.e. For access to the full library of product manuals, visit the Medtronic Manual Library. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. For best results, use Adobe Reader to view Medtronic manuals. 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. This site uses cookies to store information on your computer. Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications, contraindications, warnings, precautions, and instructions for use. !mqHfALY48 cexRM_ #6O{'_SAK5sUHGOnX-6Aw !664W@q '#qJi&qI Frequent questions. 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). 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. Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials. See our stroke products, from stent retrievers to aspiration systems. Serge Bracard, Xavier Ducrocq, et al. J. Med. Umansky F, Juarez SM, Dujovny M, et al. When to Stop [published correction appears in Stroke. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Some cookies are strictly necessary to allow this site to function. (17) Sommer T, et al. . Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. 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 . Stroke. 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. 2014;45:141-145. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Purpose Stent retrievers apply mechanical force to the intracranial vasculature. 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. Please consult the approved indications 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. "MR Conditional" stent graft treating a thoracic aneurysm (Courtesy Cook), To my knowledge, there are no currently implanted stents that are considered. Download the latest version, at no charge. 2019;50(7):1781-1788. The best of both worlds: Combination therapy for ischemic stroke. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Jun 11 2015;372(24):2285-2295. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Usable length that is at least as long as the length of the thrombus. 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. Read robust data about the safety and efficacy of the Solitaire revascularization device. Neurological Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. A total of 19 patients having under-gone intracranial stenting for aneurysms were imaged by MRI at 1.5T. 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. We do not make your details available to any third parties nor do we send unsolicited emails to our members. Materials and methods: From January 2011 through January 2016, we retrospectively selected 2979 patients with acute ischemic stroke. 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. Campbell BC, Mitchell PJ, Kleinig TJ, et al. 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. Case report: 63 year old female present pulsatile headache, diplopia, III. The XIENCE V stent should not migrate in this MRI environment. Based on bench and animal testing results. Read MR Safety Disclaimer Before Proceeding. Solitaire Literature Review Aug2022. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. If you consent, analytics cookies will also be used to improve your user experience. Lancet Neurol. Or information on our products and solutions? 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. N. Engl. 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. The tables show the Gore devices that are labeled as MR conditional. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. Stroke; a journal of cerebral circulation. What should I do if I am undergoing an MRI scan? 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 is a condition called restenosis. 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. Use of the Solitaire X Revascularization Device is contraindicated under these circumstances. It was a crowning achievement, as transformative for the company as it was impressive in both size and scope. Neurological Campbell BC, Hill MD, Rubiera M, et al. Stroke. This study explores the use of Solitaire AB as an off-label vascular stent to treat stenoses in the MCA and BA. 2020 Jun;51(6):e118]. Zaidat OO, Castonguay AC, Linfante I, et al. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Jun 11 2015;372(24):2296-2306. More information (see more) 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. 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 . You just clicked a link to go to another website. No device migration or heating was induced. Magnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional The tables show the Gore devices that are labeled as MR conditional. Mar 12 2015;372(11):1009-1018. 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 . Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry. Metabolic encephalophaties are by definition those disorder of the central nervous system that are not due primarily to structural abnormalities . Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. % 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. . Home Some controversies regarding the safety of the technique were introduced by the recent publication of . J Neurosurg. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com 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. Trevo NXT ProVue Retriever is the next generation of the Trevo evolution, now optimized for combination technique use with aspiration catheters. 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. 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. 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. treatment of ischemic stroke among patients with occlusion. 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. 2016;387(10029):1723-1731. Microsurgical anatomy of the proximal segments of the middle cerebral artery. Advancement of the Solitaire X Revascularizaton Device against resistance may result in device damage and/or patient injury. 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 TR-NV13807A, TR-NV15666A, D00419703A, D00324045A. Your opinion matters to others - rate this device or add a comment. 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 Background The number of elderly patients suffering from ischemic stroke is rising. This device is supplied STERILE for single use only. Stents: Evaluation of MRI safety. 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 an updated browser, you will have a better Medtronic website experience. Patients with angiographic evidence of carotid dissection. Registration is free and gives you unlimited access to all of the content and features of this website. Solitaire X Revascularization Device does not allow for electrolytic detachment. 36746380_ Neuroimaging of Acute Ischemic Stroke Multimodal Imaging Approach for Acute Endovascular Therapy - Read online for free. Saver JL, Goyal M, Bonafe A, et al. Thrombectomy within 8 hours after symptom onset in ischemic stroke. Jadhav AP, Desai SM, Zaidat OO, et al. The Solitaire AB stent is a scaffold that do flow blood diversion and promotes the aneurysms exclusion by thrombosis. Read our cookie policy to learn more including how you may change your settings. 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. It can be scanned safely under the conditions listed in the Instructions . Products It is delivered througha standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. If the product name you seek is not listed, try looking for information by device type. Medtronic creates meaningful technologies to empower AIS physicians. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. The information on this page is current as of November 2022. A comprehensive portfolio for all AIS techniques. . MRI exams are safe for some devices. The Solitaire X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. Healthcare Professionals Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomized controlled trial. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. 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. zFOKW%:tLQ31PFb*F2h_V*AGT8o/B-~Yj3rw XyIRd!!gU9@ag}A{bk@QU3O +u"V L sI If you continue, you may go to a site run by someone else. For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size. This website is based in the U.S. and is subject to the laws and jurisdictions of the United States. The Solitaire X device is a revascularization device designed for effective clot retrieval during thrombectomy procedures for acute ischemic stroke patients. We performed the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME) trial to establish the efficacy and safety of rapid neurovascular thrombectomy. The safety of MRI within 24 hours of stent implantation has not been formally studied. stent dislodgment soon after left main coronary artery stenting. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. %PDF-1.3 The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. NOTE: A patient may have more than one implanted device. Keywords. 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. 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). Is there an increased risk of IVC filters moving during MRI? stenting of symptomatic middle cerebral artery stenosis and perioperative evaluation using high-resolution 3 Tesla MRI (2012 . 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. 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. Do not advance the microcatheter against any resistance. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Solitaire AB Neurovascular Remodeling Deviceis designed for thetreatment of intracranial neurovascular disease. Date of coronary stent placement and device manufacturer should be documented prior to MRI. ?\IY6u_lBP#T"42%J`_X MUOd 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. 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. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. 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. The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. 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). Do not cause delays in this therapy. 4 0 obj Stroke. Stroke. MR:comp is the leading company for MR safety and MR compatibility testing of implants, instruments and medical devices. The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Oral presentation at: International Stroke Conference; February 9, 2022; New Orleans, LA.