and PRECISE stents. Conditional 6 More. Patents The https:// ensures that you are connecting to the The card should include the phone number of both the surgeon who performed the implant and the patients regular physician. Company Name: CORDIS CORPORATION. N shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend. Guidelines for the Management of Patients with Coronary Artery Stents Referred for MRI Examinations, Whole body averaged specific absorption rate (SAR) of 2-W/kg (i.e., operating in the Normal Operating Mode for the MR system), Maximum imaging time, 15 minutes per pulse sequence (multiple pulse sequences per patient are allowed). Cookie Consent, RAIN Sheath Transradial Thin-Walled Introducer, Universal Shapes, INFINITI and SUPER TORQUE Plus Diagnostic Catheters, S.M.A.R.T. * This website contains information on products for a wide range of countries. Radiology 1993;189:587-599. This site needs JavaScript to work properly. Interventional. Panalok Absorbable AnchorNonmetallicDepuywww.Depuy.com, Panalok Anchorclear PLA polymer anchorMitek ProductsNorwood, MA, Panalok Loop AnchorNonmetallicDepuywww.Depuy.com, Panalok RC Loop AnchorNonmetallicDepuywww.Depuy.com, Panalok RC QA+DS Suture OrthocordNonmetallicDepuywww.Depuy.com, Panalok RC QuickAnchor PlusNonmetallicDepuywww.Depuy.com, Panje Voice ButtonHood Laboratories, www.hoodlabs.com, Papoos Infant Spinal Immobilization DeviceOssur, www.ossur.com, Paragard Intrauterine Copper Contraceptive Cooper Surgical, ParaMount Mini Biliary StentCovidien and ev3 Inc., www.ev3.net, Partial and Total Prosthesis Device Family, Partial and Total Prosthesis; Family Product Number(s), 1XX, 190-XXX; Device Material(s), HA, hydroxyapatiteGrace Medical, www.gracemedical.com, Partial and Total ProsthesisDevice Family, Partial and Total Prosthesis; Family Product Number(s), 2XX, 193; Device Material(s), HA (hydroxyapatite), SiliconeGrace Medicalhttp://www.gracemedical.com/, PAS-Port ProximalAnastomosis System ImplantCardica and Dextera Surgical, Inc., www.dexterasurgical.com, PAS-Port Shaped ImplantDextera Surgical, www.dexterasurgical.com, Passager Stent (tantalum)10 mm x 30 mmcoil, stent, filterMeadox SurgimedOakland, NJ, Passager Stent (tantalum)4 mm x 30 mmcoil, stent, filterMeadox SurgimedOakland, NJ, Patellofemoral joint (PFJ) Reconstruction SystemIBalance PFJ, Entire Family, All SizesArthrex, Inc., www.arthrex.com, Patient ScoopModel 65 EXLFerno-Washington, Inc.Wilmington, OH, Patriot Extrication CollarOssur, www.ossur.com, pBEAST Peripheral Balloon Expandable Covered StentW. We do not endorse or condone any type of plagiarism. Peripheral artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion; it . The PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Terms and Conditions and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). Paul, M, Deltec Micro 3100Large Volume Infusion PumpSmiths MedicalSt. Is there a clear connection to practice and theory in your specific nursing specialty area? Metal introducer tube included in the package 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. Magnetic resonance compatibility research for coronary metal stents. For country-specific contact details, please see this page. Primary DI Number: 20705032036389. Signals No. Silk Road Medical (SRM) has entered into a license and However, in consideration of the relevant peer-reviewed literature and other related documents (3-24), it is acceptable and safe to perform MRI examinations in patients with coronary artery stents by following specific guidelines developed by taking into consideration possible safety concerns (i.e., magnetic field interactions and MRI-related heating) for these implants. Stents: Evaluation of MRI safety. This dilatation catheter offers excellent crossability and deliverability for navigation through tortuous anatomy and difficult lesions. Reason for Recall. Am J Roentgenol 1999;173:543-546. Furthermore FlexSegments and Cordis Nesting technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. PALMAZ GENESIS Transhepatic Biliary Stent Cordis, A Johnson and Johnson Co. http://www.cordis.com Available whenever, wherever. Older Stents People who had a coronary stent placed after 1998 may have a drug-eluting device. Privacy Statement Laser cut slotted tube for device integrity (no welds) Patents Intracranial stent. Interventionalists and their teams now have 60 years of Cordis knowledge in their hands and at their fingertips. References (1) Shellock FG, Crues JV. PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium), PALMAZ GENESIS Stent on OPTA PRO Catheter (Large). Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Version or Model: PG3970BPX Commercial Distribution Status: In Commercial Distribution Catalog Number: PG3970BPX Company Name: CORDIS CORPORATION Through a series of procedurally based coronary and endovascular modules, users can expand their skills and master Cordis tools. Cookie Consent, RAIN Sheath Transradial Thin-walled Introducer, BRITE TIP Interventional Sheath Introducer, TEMPO AQUA Hydrophilic Angiographic Catheter, STABILIZER Balance Performance Steerable Guidewire, ANGIOGUARD RX Emboli Capture Guidewire System, AVIATOR Plus PTA Balloon Dilatation Catheter, SLEEK OTW 0.014" PTA Dilatation Catheter, S.M.A.R.T. 8600 Rockville Pike Notably, the previous belief that it may be necessary to wait six weeks or longer after implantation of certain coronary artery stents to allow for endothelialization or other mechanism to prevent migration has been refuted because there are no known coronary artery stents made from ferromagnetic metallic materials (4-24). When the item is expired must be used for educational, training, veterinary or non-clinical research purposes only. A Cardinal Health company Open the catalog to page 1 This site has been created to provide information on our products to medical professionals. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. (16) Shellock FG. Please refer to the Indications for Use for complete information, including indications, precautions, warnings, and potential adverse events. Brand Name: Cordis PRECISE PRO Rx Nitinol Stent System. Cause 2. Low profile .035 stent delivery system Cristallo Ideale Carotis Self-Expanding Stent Cylindrical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. 2006 Jun;54:469-80. The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. for Recall. Manufacturer Reason. GMDN Preferred Term Name GMDN Definition; Peripheral artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion; it might . Furthermore FlexSegments and Cordis Nesting+ technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. Braun, www.bbraunusa.com, Cytoscan NeedleB. Codman Neurovascular and Depuy Synthes, www.depuysynthes.com. The surgeon who performed the surgery should have more information about what devices were implanted and whether an MRI is safe, and MRI technicians who have a patient's complete medical file can usually make better judgments, too. API expert consensus document on management of ischemic heart disease. Eur Radiol 2009;19:2913-8. Catalog Number: PC0730RXC. Privacy Statement Device Component Description The device component consists of a stent mounted onto a stent delivery system (SDS). Specifications. Cordis adds the next generation of high-performance workhorse PTA balloons with the SABER.035 PTA Dilatation Catheter. (14) Schenk CD, Gebker R, Berger A, et al. (3) Shellock FG. PALMAZ GENESIS on OPTA PRO (Large) Most arent permanent, though, and people who have them do typically need to exercise certain precautions when it comes to keeping them in place and protecting their heart health generally. Device Identifier (DI) Information. As a result, it may contain information about products not available in your country. Select a Region (3) The MRI examination must be performed using the following parameters: Important Note: This information does not apply to other stents such as peripheral vascular stents, abdominal aortic aneurysm (AAA) stent grafts, biliary stents, ureteral stents, or stents used for other applications (e.g., tracheobronchial stents, esophageal stents, etc.). MRI radiographers and healthcare professionals in the UK have been asked to 'read and understand the updated compatibility information' and share with relevant people in their organisations. (20) Spuentrup E, et al. Larry in Missouri - According to the MRI . The PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Welcome to Cordis's Electronic Instructions for Use (eIFU) website. Clipboard, Search History, and several other advanced features are temporarily unavailable. (11) Karamitsos TD, Karvounis H. Magnetic resonance imaging is a safe technique in patients with prosthetic heart valves and coronary stents. (2) Patients with all commercially available coronary artery stents can undergo MRI immediately after placement of these implants. Medical Transparency Device Family, Partial and Total Prosthesis; The ends of the stent are flared and feature four radiopaque tantalum markers at each end. Biomedical implants and devices: Assessment of magnetic field interactions with a 3.0-Tesla MR system. Importance of Consultation Many people with coronary artery stents also have other implanted devices that include coils, filters and wires. (13) Porto I, et al. The magnetic field could dislodge the object, while radio waves could make it heat up. Cordis US Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2020 Edition. CORDIS PG3990BPS Palmaz Genesis Transhepatic Biliary Stent, Balloon-Expandable Stent And Delivery System, 80cm, 9mm, 9.4mm, 35mm, 40mm, 39mm, 7F, .035 (X) 2018-03. J Magn Reson Imaging 2002;16:721-732. Stents are typically considered MRI-safe, but anyone with a stent in place would be wise to get a professional opinion on their specific situation before proceeding. While radio waves could make it heat up for country-specific contact details please. 2 ) patients with all commercially available coronary artery stents can undergo MRI after... Cd, Gebker R, Berger a, et al after 1998 may have a device. S Electronic Instructions for Use ( eIFU ) website available in your country Thurgau, Switzerland Cristallo Ideale Self-Expanding. These implants object, while radio waves could make it heat up consensus document on management of heart! R, Berger a, et al implanted devices that include coils, filters and wires Cordis a... 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