If you are located in Australia, China, India, Japan or Korea, please direct your order or question directly to your countrys contact. (14) Schenk CD, Gebker R, Berger A, et al. Older Stents People who had a coronary stent placed after 1998 may have a drug-eluting device. Biomedical Research Publishing Group, Los Angeles, CA, 2020. Cerebrospinal Fluid (CSF) Shunt Valves and Accessories More. device Performance The FDA under section 514 of the Food, Drug and Cosmetic Act has not standards established performance standards for these devices. Diagnostic. Cordis Endovascular Medical Info Line. Cookie Consent, RAIN Sheath Transradial Thin-Walled Introducer, Universal Shapes, INFINITI and SUPER TORQUE Plus Diagnostic Catheters, S.M.A.R.T. Go to the Cordis website for more information, Pre-mounted PALMAZ GENESIS Stent (Large). The PALMAZ GENESIS Peripheral Stent family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Medical Transparency Commercial Distribution End Date: This website contains information on products for a wide range of countries. (7) Gerber TC, et al. 2004 Mar;29(2):181-6. doi: 10.1007/s00059-004-2560-x. Stainless steel One of the biggest concerns people have when undergoing MRIs is that the magnetic force of the scans will somehow knock the stents out of place. This site has been created to provide information on our products to medical professionals. official website and that any information you provide is encrypted Conditional 6 More. As we celebrate one year of independence, we are even more proud than we were 62 years ago to stand behind the heroes that allow us all to be truly free at heart. (22) Tejedor-Viuela P, et al. The number of coronary stents may be over half a million world-wide. The procedure is considered noninvasive because it doesnt involve incisions or internal disruption, but it isnt without its risks. Patients usually have to spend time lying very still in an MRI machine, which is a contained space where controlled magnetic waves penetrate and bounce. Its often the case that the care team providing the MRI isnt the same as the one that installed the stent, so they might not be aware that it is present. 26-27, 2005. MIAMI, April 20 -- Cordis Corporation, a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has approved a condition of use for the CYPHER Sirolimus-eluting Coronary Stent, allowing patients receiving the stent to immediately undergo Magnetic Resonance Imaging (MRI) following implantation. DELTAMAXX Microcoil, Embolization Coil. Privacy Statement These stents also are generally safe during an MRI, but more caution may be needed to ensure that the magnetic activity doesn't change the drug distribution schedule. Important Note: These guidelines must be reviewed on an annual basis to confirm that no new coronary artery stent has become available that substantially deviates from the above MRI conditions or that is labeled, MR Unsafe (24). MeSH Cristallo Ideale Carotis Self-Expanding StentConical versionNitinol Invatec Technology Center GmbHThurgau, Switzerland, Cristallo Ideale Carotis Self-Expanding StentCylindrical versionNitinol Invatec Technology Center GmbHThurgau, Switzerland, Crossflex Stent316L SScoil, stent, filterCordisMiami, FL, Crown PRT Aortic Pericardial Heart ValveLivaNova, www.livanova.sorin.com, Crown Stent316L SScoil, stent, filterCordisMiami, FL, Crutchfield (SS)carotid artery vascular clampCodmanRandolf, MA, Crux FilterVena cava filterNitinolCrux Biomedical, Inc.Portola Valley, CA, CRx Universal Shuntcerebral spinal fluid (CSF)shunt valveSophysawww.sophysa.com, CRx valvecerebral spinal fluid (CSF)shunt valveSophysawww.sophysa.com, CSF Flow Control Valve, Fixed PressureMedtronic, Inc., www.medtronic.com, CT Rated Dual Port, Vascular Access PortMedcomp, www.medcompnet.com, Cube (with drainage holes)PessaryCooperSurgical, Inc.Trumbull, CT, Cube with DrainEvaCarePessarySiliconeColoplast CorporationMinneapolis, M, CubeEvaCarePessarySiliconeColoplast CorporationMinneapolis, M, CubePessaryCooperSurgical, Inc.Trumbull, CT, CubePessarysiliconeBioteque America, Inc.Fremont, CA, CUFF LINK Bone Tunnel DeviceNonmetallicDepuywww.Depuy.com, Cup PessaryEvaCarePessarySiliconeColoplast CorporationMinneapolis, M, CupPessarysiliconeBioteque America, Inc.Fremont, CA, Curvilinear Silicone Chin ImplantImplantech Associates, Inc., www.implantech.com. (6) Curtis JW, Lesniak DC, Wible JH, Woodard PK. Brand Name: Cordis PRECISE PRO Rx Nitinol Stent System. CONTROL Nitinol Stent Delivery System, PALMAZ GENESIS Stent on SLALOM Medium .018 Catheter Brochure, Cordis PALMAZ GENESIS Large .035 Brochure, One piece laser cut stainless steel slotted tube (no welds), Laser cut slotted tube for device integrity (no welds), S shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend, Lengths of delivery system: 80 and 135 cm, Metal introducer tube included in the package, N shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend. The PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. (13) Porto I, et al. Importantly, there has never been an adverse event reported in association with performing MRI in patients with these particular implants. Closed-cell design (8) Hug J, et al. Patents Through a series of procedurally based coronary and endovascular modules, users can expand their skills and master Cordis tools. Stents are basically small tubes or sometimes springs that help prop arteries open. The Genesis family is designed according to the PALMAZ GENESIS Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. These stents have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. Is It Safe to Combine Trazodone and Sertraline? and PRECISE stents. It has an extensive size matrix allowing for the treatment of a wide range of lesions. sharing sensitive information, make sure youre on a federal Low profile .035 stent delivery system References (1) Shellock FG, Crues JV. This device can be safely used in patients undergoing MRI scans using 3 Tesla (3T) machines. 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. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. FDA Determined. The PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Furthermore FlexSegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability*. Cordis US Expert Rev Med Devices 2021;18:83-90. This is a European Website and its content is not compliant with French advertising regulation law n 2011-2012 du 29 December 2011, article 34. [Optimal platelet inhibition after coronary stent implantation. Intracranial stent. Select a Region Cookie List For over half a century, Cordis has connected and collaborated across the industry, with a mission to invent better ways to serve clinicians and their collaborators. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. MRI safety guidelines are established by the MRI Safety Committee and apply to all clinical and research MRI systems operated at UCSF and SFVAHCS. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. MRI Basics MRIs are essentially scans of the body that can give diagnosticians a very clear view of certain organs or internal processes without actually having to surgically open a patient. Terms and Conditions MR procedures: Biologic effects, safety, and patient care. Are Current Cardiovascular Stents MRI Safe? Am J Roentgenol 1999;173:543-546. (17) Shellock FG, Morisoli S, Kanal E. MR procedures and biomedical implants, materials, and devices: 1993 update. T a bl e 3 M. a or Adverse Events In-H . Cookie Consent, Catheter Sheath Introducers & Sheathless Devices, RAIN Sheath Transradial Hydrophilic Thin-walled Introducer, SUPERTORQUE and SUPERTORQUE Plus Diagnostic Catheters, IKAZUCHI ZERO Semi-Compliant PTCA Balloon, SLEEK OTW 0.014" PTA Dilatation Catheter, S.M.A.R.T. The RAILWAY Sheathless Access System is a versatile system for reducing access up to 2F1. Terms and Conditions Biomedical implants and devices: Assessment of magnetic field interactions with a 3.0-Tesla MR system. Cordis has initiated a labeling correction for S.M.A.R.T. Closed-cell design 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. Primary DI Number: 20705032036457. Issuing Agency: GS1. Magnetic resonance imaging safety: Implications for cardiovascular patients. Pre-mounted PALMAZ GENESIS Stent (Large) 1 / 2 Pages Catalog excerpts .035" Over-the-wire System PALMAZ GENESIS on OPTA Pro (Large) PALMAZ* Genesis" Rated burst Pressure: 10 atm Nominai pressure: s atm designed for life Ordering Information Cordis. 3: Conditional 6 More. Careers. The delivery system consists mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy . Cristallo Ideale Carotis Self-Expanding Stent Cylindrical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. 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 following guidelines apply to using MRI in patients with coronary artery stents (including patients with two or more stents or two or more overlapping stents): (1) Patients with all commercially available coronary artery stents (including drug-eluting and non-drug eluting or bare metal versions) can be scanned at 1.5-Tesla/64-MHz or 3-T/128-MHz, regardless of the value of the spatial gradient magnetic field. (20) Spuentrup E, et al. MR safety at 3-Tesla: Bare metal and drug eluting coronary artery stents. 2009 Nov 15;104(10):1362-9. doi: 10.1016/j.amjcard.2009.06.058. ), patients with coronary artery stents have safely undergone MRI examinations, including those performed at 1.5- and 3-Tesla. 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. PALMAZ Large Stents can be expanded between 8 and and 12 mm and the XL can be expanded between 14 and 25 mm. Unable to load your collection due to an error, Unable to load your delegates due to an error. (15) Shellock FG. The PALMAZ GENESIS Peripheral Stent family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Please note that access to the following pages is exclusively reserved to Cordis employees and healthcare professionals in Europe, the Middle East, and Africa that are willing and can receive information in English. Please understand that it is not intended to provide information to the general public. 8600 Rockville Pike Bookshelf You may use this site to download electronic versions of product Instructions For Use by . By adhering to these admittedly conservative MRI conditions, patients with coronary artery stents can benefit from the diagnostic imaging information provided by one of the most important noninvasive imaging modalities. Int J Cardiovasc Imaging.2013;29:1485-90. (2) Shellock FG, Woods TO, Crues JV. There are a couple of reasons why arteries collapse or shrink, usually with age and often as a consequence of some sort of heart defect or problem; stents are an easy and usually effective treatment option. The PALMAZ GENESIS Stent Family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. CYTOGUARD Closed Male Luer ConnectorB. Epub 2009 Sep 26. They have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. Company Name: CORDIS CORPORATION. As a result, it may contain information about products not available in your country. 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Braun Medical, www.bbraun.com, Dana Diabecare IISG Insulin PumpSooil, www.sooilusa.com, DC GDC 10-Soft SR Platinum alloy coil Boston Scientific Corporation and Stryker Neurovascular, www.stryker.com, De La CruzFluoroplastic, Platinum, PistonOtologic ImplantMedtronic Xomed, Jacksonville, T, Deck Scraper45*300-mmNewmatic Medical, www.newmaticmedical.com, Deck ScraperS-11GAmpco Safety ToolsGarland, TX, Delta Shunt AssemblyMedtronic NeurosurgeryGoleta, CA, Delta Tapered PEEK Interference ScrewArthrex, www.Arthrex.com, Delta Total ShoulderStainless SteelDePuy OrthopaedicsWarsaw, I, Delta TRSType DDDModel 0937PacemakerCardiac Pacemakers, Inc.St. Paul, M, Delta Valveintraventricular pressure valvenonmetallicMedtronicMinneapolis, M, DELTAFILL Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAMAXX Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAPAQ Microcoilembolization coilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAPLUSH Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, DELTAXSFT Microcoil, Embolization CoilCodman Neurovascular and Depuy Synthes, www.depuysynthes.com, Deltec 3000Large Volume Infusion PumpSmiths MedicalSt. Lengths of delivery system: 80 and 135 cm FOIA J Magn Reson Imaging. Coronary arterial stents: Safety and artifacts during MR imaging. Patents Safety of early cardiac magnetic resonance imaging in acute myocardial infarction patients with stents. Manufacturer Reason. Review of safety reports of cardiac MR-imaging in patients with recently implanted coronary artery stents at various field strengths. This may result in restricted access to MRI for certain patients, particularly those with coronary artery stents for which there is unknown labeling information. At the center of our passion for advancing cardiovascular and endovascular health are the clinicians and collaborators on the frontlines. (18) Shellock FG, Shellock VJ. Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. Cordis Announces Acquisition of MedAlliance, Positioning Itself for Market Leadership in Drug-Eluting Balloon Technology, Multi-center study to evaluate safety and efficacy of S.M.A.R.T.
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