solitaire stent mri safety

Home 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. The Solitaire X Revascularization Device is not to be used after the expiration date imprinted on the product label. With an updated browser, you will have a better Medtronic website experience. Our AIS portfolio offers comprehensive, compatible solutions that give your patients a better chance to walk away from AIS. Please consult the approved indications for use. 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). Medical Information Search As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of notified bodies. Campbell BC, Mitchell PJ, Kleinig TJ, et al. . Do not treat patients with known stenosis proximal to the thrombus site. 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. The aim of this study was to understand the efficacy and safety of MT in elderly patients, many of whom may have baseline impairment. Atherosclerosis, Endovascular, Enterprise, Intracranial stenosis, Stent . A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. FPE defined as mTICI2c/3; modified FPE defined as mTICI 2b-3. 2016;387(10029):1723-1731. Do not recover (i.e. > The idea was that the stent needed time to "settle in" and become incorporated in the vessel wall before risking displacement by magnetic forces. First pass effect: A new measure for stroke thrombectomy devices. (17) Sommer T, et al. 1,2 The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. << /Length 5 0 R /Filter /FlateDecode >> In addition to conventional T2- and diffusion-weighted MRI, 3D time-of-ight MRA was performed before and after Read MR Safety Disclaimer Before Proceeding. This site is Exclusively Sponsored by BRACCO, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices, Cardiovascular Catheters, Other Catheters, and Accessories. 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 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. Solitaire X. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. Update my browser now. Our team is happy to help answer any questions you may have. RESULTS: All except two types of stents showed minimal ferromagnetism. "MR Conditional" stent graft treating a thoracic aneurysm (Courtesy Cook), To my knowledge, there are no currently implanted stents that are considered. Some cookies are strictly necessary to allow this site to function. Lancet Neurol. Do not advance the microcatheter against any resistance. J Neurosurg. Bench and animal testing may not be representative of actual clinical performance. If a stent is put into a patient's bile duct during an MRI, it will not be visible. 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. With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. 2018;49(10):2523-2525. Goyal M, Demchuk AM, Menon BK, et al. N. Engl. N. Engl. Enterprise stent for the treatment of symptomatic intracranial atherosclerotic stenosis: an initial experience of 44 patients Authors. N. Engl. Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. Stents: Evaluation of MRI safety. Oct 2013;44(10):2802-2807. % A. Indications, Safety, and Warnings. With an updated browser, you will have a better Medtronic website experience. Is there an increased risk of IVC filters moving during MRI? Mar 12 2015;372(11):1019-1030. Tomasello A. J. Med. 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. . WhichMedicalDevice is a FREE resource created by clinicians for clinicians. Endovascular therapy with the device should be started within 6 hours of symptom onset. > The information from the scan may help your doctor decide if you need another stent. Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. Pereira VM, Gralla J, Davalos A, et al. Zaidat OO, Castonguay AC, Linfante I, et al. Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. A total of 20 stents were placed in 19 patients. 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. Solitaire AB Neurovascular Remodeling Deviceis designed for thetreatment of intracranial neurovascular disease. Stroke. Purpose Stent retrievers apply mechanical force to the intracranial vasculature. The "conditions" associated with some stents recommend that whole-body-averaged SAR levels not exceed 2 W/kg and a maximum of 15 minutes per sequences, while other stents permit up to 4 W/kg. AIS Revascularization Products Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke. B. Randomized trials of mechanical thrombectomy (MT) generally exclude patients over the age of 80 years with baseline disability. NOTE: A patient may have more than one implanted device. It is delivered througha standard 0.021" or 0.027" micro catheter on a 0.016" pushwire. 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. The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. Some controversies regarding the safety of the technique were introduced by the recent publication of . For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com. 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. 2022;53(2):e30-e32. TN Nguyen & Al. Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris. For indication 3, users should validate their imaging analysis techniques to ensure robust and consistent results for assessing core infarct size. 2016;47(3):798-806. The size of imaging artifacts was measured with all the stents under standardized conditions and with six stents after their implantation into the coronary arteries of freshly explanted pig hearts. Thrombectomy within 8 hours after symptom onset in ischemic stroke. To be fair and balanced, there is a single controversial case report from 2013 (Parthasarathy H, Saeed O, Marcuzzi D, Cheema AN. MRI is base on safe interaction between radiowaves at a particular frequency and hydrogen nuclei in the body. 2022 The Regents of the University of California | Accessibility | Terms of Use | Privacy Policy, (T32) Biomedical Imaging for Clinician Scientists. Apr 23 2016;387(10029):1723-1731. 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. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. Click OK to confirm you are a Healthcare Professional. Your opinion matters to others - rate this device or add a comment. This is a condition called restenosis. Vascular stream Healthcare professionals must research the conditions for use and instructions for each implanted device before proceeding with MRI procedures. 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. The deviceis a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. Circ Registration is quick and free. 2019;50(7):1781-1788. Do not reprocess or re-sterilize. 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 hemodynamic effect of a stenosis can be assessed via perfusion weighted MRI (PWI). 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! 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 Neurological Please consult the approved indications for use. Jan 1 2015;372(1):11-20. Do not torque the Solitaire X Revascularization Device. 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. 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. 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 . 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 . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. Umansky F, Juarez SM, Dujovny M, et al. You just clicked a link to go to another website. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. 2016; 15: 113847. It is possible that some of the products on the other site are not approved in your region or country. 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. 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. For a full version of conditions, please see product Instructions for Use (IFU). First pass effect with neurothrombectomy for acute ischemic stroke: Analysis of the systematic evaluation of patients treated with stroke devices for acute ischemic stroke registry. Do you need support for procedures? Your use of the other site is subject to the terms of use and privacy statement on that site. When the GORE VIABAHN Endoprosthesis/GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface was placed within a bare nitinol stent the image artifact extended up to 20 mm from the devices. Categorised under: 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. They are typically inserted during a procedure called. Update my browser now. Registration gives you full access to all of the features of WhichMedicalDevice. It was a crowning achievement, as transformative for the company as it was impressive in both size and scope. 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. 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. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomized controlled trial. 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 J. Med. NV AIS Solitaire X Animation . Home 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. Endovascular therapy for ischemic stroke with perfusion-imaging selection. Stroke. Registration is free and gives you unlimited access to all of the content and features of this website. No device migration or heating was induced. 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. Jun 11 2015;372(24):2285-2295. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire X Revascularization Devices. You can read our Privacy Policy here. 36746380_ Neuroimaging of Acute Ischemic Stroke Multimodal Imaging Approach for Acute Endovascular Therapy - Read online for free. zFOKW%:tLQ31PFb*F2h_V*AGT8o/B-~Yj3rw XyIRd!!gU9@ag}A{bk@QU3O +u"V L sI 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 device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance.1,2 More information (see more) This site uses cookies to store information on your computer. Case report: 63 year old female present pulsatile headache, diplopia, III. Stroke. Garca-Tornel , Requena M, Rubiera M, et al. 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. A comprehensive portfolio for all AIS techniques. 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 ). How about other GU devices like nephrostomy tubes and stents? When to Stop [published correction appears in Stroke. Carefully inspect the sterile package and the Solitaire X Revascularization Device prior to use to verify that neither has been damaged during shipment. Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke: primary results of the STRATIS registry. Read robust data about the safety and efficacy of the Solitaire revascularization device. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration. MRI-induced 2017;48(10):2760-2768. Update my browser now. If excessive resistance is encountered during recovery of the Solitaire X Revascularization Device, discontinue the recovery and identify the cause of the resistance. Less information (see less). 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). 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). 2020 Jun;51(6):e118]. 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. Implantable Cardiac Devices - MR Conditional Status, Find MRI technical support phone numbers and supplemental MRI resources. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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. Bench testing may not be representative of actual clinical performance. Solitaire X Metabolic encephalophaties are by definition those disorder of the central nervous system that are not due primarily to structural abnormalities . Medtronic creates meaningful technologies to empower AIS physicians. 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. Stroke. The drug is slowly released to help keep the blood vessel from narrowing again. Lancet. Download the latest version, at no charge. If the product name you seek is not listed, try looking for information by device type. The presence of this implant may produce an image artifact. This MRI Resource Library is filtered to provide MRI-specific information. Do not use kinked or damaged components. Products This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. More information (see more) #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. Initiate mechanical thrombectomy treatment as soon as possible. Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the Solitaire X Revascularization Device. MRI Information. It can be scanned safely under the conditions listed in the Instructions . Date of coronary stent placement and device manufacturer should be documented prior to MRI. Contact Medtronic | Terms of Use | Privacy Statement | Medtronic Manual Library | Choose Region, (such as 9528, 3875-45, 305U219, ENSP30030W), (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim), (such as pacemaker, stent, otology implants, drug pump), All conditions for use for all implanted devices, The associated risks for a patient with these devices. 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. The Solitaire X Revascularization Device should only be used by physicians trained in interventional neuroradiology and treatment of ischemic stroke. 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. 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. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V stent. Few data are available for comparing the therapeutic effects associated with the two mechanical thrombectomy techniques in acute ischemic stroke with atrial fibrillation. Saver JL, Goyal M, Bonafe A, et al. nial stents and to assess the utility of performing gadolin-ium-enhanced MRA. J. Med. The best of both worlds: Combination therapy for ischemic stroke. Drug-coated stents have been approved for use by the U.S. Food and Drug Administration (FDA). Indications, Safety and Warnings IFU 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. - (00:00), NV AIS Solitaire X Animation Based on smallest vessel diameter at thrombus site. For best results, use Adobe Reader to view Medtronic manuals. The XIENCE V stent should not migrate in this MRI environment. Keywords. Frequent questions. 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. The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. Among . pull back) the device when encountering excessive resistance. 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. A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. Based on bench testing results. MRI exams are safe for some devices. Am J Roentgenol 1999;173:543-546. Read our cookie policy to learn more including how you may change your settings. 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. Healthcare Professionals Subscribe to our newsletter. 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 . 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. The Solitaire X revascularisation device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion. Microsurgical anatomy of the proximal segments of the middle cerebral artery. With an updated browser, you will have a better Medtronic website experience. 4 0 obj Usable length that is at least as long as the length of the thrombus. 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. 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.