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 ). 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. 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. 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. 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 . > The XIENCE V stent should not migrate in this MRI environment. Purpose Stent retrievers apply mechanical force to the intracranial vasculature. Some controversies regarding the safety of the technique were introduced by the recent publication of . 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. J. Med. Please consult the approved indications for use. 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. Do not treat patients with known stenosis proximal to the thrombus site. It is possible that some of the products on the other site are not approved in your region or country. More information (see more) Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. No device migration or heating was induced. The information on this page is current as of November 2022. !mqHfALY48 cexRM_ #6O{'_SAK5sUHGOnX-6Aw !664W@q '#qJi&qI 1,2 The Solitaire X device has a unique parametric design that has been fundamental to the generations of the Solitaire portfolio. The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen. 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. Please help keep this site free for everyone in the world! Please consult the approved indications for use. J. Med. Jovin TG, Chamorro A, Cobo E, et al. A total of 20 stents were placed in 19 patients. As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of notified bodies. % With an updated browser, you will have a better Medtronic website experience. With an updated browser, you will have a better Medtronic website experience. Do not torque the Solitaire X Revascularization Device. 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. More information (see more) This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. Medical Information Search Nearly all metal stents are made of non-ferric materials such as 300-series stainless steel, Nitinol, Elgiloy, or other alloys. With an updated browser, you will have a better Medtronic website experience. nial stents and to assess the utility of performing gadolin-ium-enhanced MRA. Products Zaidat OO, Castonguay AC, Linfante I, et al. 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. Neurological Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. 2014;45:141-145. A comprehensive portfolio for all AIS techniques. Among . Avoid unnecessary handling, which may kink or damage the Delivery System. 2016;47(3):798-806. This means that the devices have demonstrated safety in a specified MRI environment with the defined conditions of use listed. For access to the full library of product manuals, visit the Medtronic Manual Library. 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. Indications, contraindications, warnings and instructions for use can be viewed at www.medtronic.com/manuals. A stent-graft is an expandable metal stent covered with fabric that forms its own lumen and is commonly placed in aneurysms. &dR~% '7) W P2yob)eRUX@F&oE+7" % The aim of this study was to understand the efficacy and safety of MT in elderly patients, many of whom may have baseline impairment. 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). Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. 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. For indication 3, endovascular therapy with the device should be started within 16 hours of symptom onset. 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. Home Oct 2013;44(10):2802-2807. Artifacts extended both inside and outside the device lumen. Oral presentation at: International Stroke Conference; February 9, 2022; New Orleans, LA. Learn more about navigating our updated article layout. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. Sorin Allcarbon, AS Model MTR-29AS, 29 mm pyrolitic carbon Heart Valve Sorin Biomedica Cardio S.p.A. Saluggia, Italy 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. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. You can read our Privacy Policy here. Frequent questions. 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. << /Length 5 0 R /Filter /FlateDecode >> Jan 1 2015;372(1):11-20. Mueller-Kronast NH, Zaidat OO, Froehler MT, et al. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use. WhichMedicalDevice is a FREE resource created by clinicians for clinicians. The device is a self-expanding stent designed for bridging the neck of aneurysms that can be fully retrieved when fully deployed. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta-analysis of individual patient data from five randomised trials. Less information (see less). Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. TN Nguyen & Al. Goyal M, Menon BK, van Zwam WH, et al. For a full version of conditions, please see product Instructions for Use (IFU). Neurological Flottmann F, Leischner H, Broocks G, et al. The information from the scan may help your doctor decide if you need another stent. Indications, Safety, and Warnings. A nondetachable balloon is inflated in front of the aneurysm neck during coil deposition and removed at the end of the procedure. Copyright 2002-2023 | W. L. Gore & Associates, Inc. | Products listed may not be available in all markets. Products To be fair and balanced, there is a single controversial case report from 2013 (Parthasarathy H, Saeed O, Marcuzzi D, Cheema AN. 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. SMart Piston Otologic Implant Fluoroplastic/Nitinol Gyrus ACMI (Olympus Medical), www.medical.olympusamerica.com Goyal M, Demchuk AM, Menon BK, et al. > A. This is a condition called restenosis. J. Med. Indications, Safety and Warnings IFU Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomized trials. Based on bench testing results. If you continue, you may go to a site run by someone else. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. Stroke. zFOKW%:tLQ31PFb*F2h_V*AGT8o/B-~Yj3rw XyIRd!!gU9@ag}A{bk@QU3O +u"V L sI If you don't know the exact model of the stent you are scanning it is therefore safer to use the lower limit. This stent can be safely scanned in an MR system meeting the following . MRI-induced 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. Read our cookie policy to learn more including how you may change your settings. AIS Revascularization Products 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). Saver JL, Goyal M, Bonafe A, et al. Read MR Safety Disclaimer Before Proceeding. Usable length that is at least as long as the length of the thrombus. The study will demonstrate safety and efficacy of the SOLITAIRE Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke. The Solitaire device has become the most-published stent retriever with over 200 publications demonstrating clinically proven, tried-and-true performance. stent dislodgment soon after left main coronary artery stenting. Microsurgical anatomy of the proximal segments of the middle cerebral artery.
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