Cordis adds the next generation of high-performance workhorse PTA balloons with the SABER .035 PTA Dilatation Catheter. 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. Cordis US Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. Clinical safety of cardiac magnetic resonance imaging at 3 T early after stent placement for acute myocardial infarction. PALMAZ GENESIS Transhepatic Biliary Stent Cordis, A Johnson and Johnson Co. http://www.cordis.com Kaya MG, Okyay K, Yazici H, Sen N, Tavil Y, Turkoglu S, Timurkaynak T, Ozdemir M, Cemri M, Yalcin R, Cengel A. Coron Artery Dis. Terms and Conditions FOIA Metal introducer tube included in the package For Additional Information Contact. They have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Select a Region Coils, Filters, Stents, and Grafts More. (23) Wang Y, et al. 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. 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. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. 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. CONTROL Self-Expanding Nitinol Stent, 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 purpose of this communication is to inform you that Cordis is issuing a field safety notice for Cordis S.M.A.R.T. They use magnetic energy to specifically identify the location of internal organs, glands, and passageways, and in most cases the results are remarkably clear and accurate. They have an optimal scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. This system features a smaller access profile than any radial sheath, and compatibility with a variety of guiding catheters.1 Compared to conventional radial sheaths. Terms and Conditions For more information, please contact your local Cordis representative. Partial and Total Prosthesis. BRUSSELS, Belgium, April 15 /PRNewswire-FirstCall/ -- Cordis Corporation, a Johnson & Johnson company, today reported its new CYPHER(TM) Sirolimus- eluting Stent received CE Mark approval in Europe for treatment of de novo coronary artery lesions (less than or equal to 30 mm in length) in native MR safety at 3-Tesla: Bare metal and drug eluting coronary artery stents. Accessories. Interventionalists and their teams now have 60 years of Cordis knowledge in their hands and at their fingertips. CONTROL Vascular Stent System. Before 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. High field MR imaging: Magnetic field interactions of aneurysm clips, coronary artery stents and iliac artery stents with a 3.0 Tesla MR system. The neurologist and radiologist are frequently confronted with cardiac patients who have had a recent carotid or coronary stent implanted and present with an acute and unrelated stroke for which an MRI is recommended. 2009 Mar;20(2):138-42. doi: 10.1097/MCA.0b013e328322cd48. By following the pertinent MRI labeling information (i.e., presented in the Instructions for Use, Patient Identification Card, etc. RADIANZ Vascular Stent System via Radial Access. Eur Radiol 2009;19:2913-8. The RAILWAY Sheathless Access System is a versatile system for reducing access up to 2F1. Both stents are mounted on the Raptor Rapid Exchange Stent Delivery System. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. Furthermore FlexSegments and Cordis Nesting technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. All items listed are on inventory. Cordis is a worldwide leader in the development and manufacture of interventional vascular technology with a more than 50-year history of delivering pioneering products to treat millions of patients. 2.0 Description The Cordis PRECISE Nitinol Stent System consists of a nitinol self-expanding stent preloaded on a 5.5F (1.85 mm) or 6F (2.0 mm) sheathed delivery system. Please refer to the Indications for Use for complete information, including indications, precautions, warnings, and potential adverse events. PMC For all other Latin American countries, please email us with your question or order. Unable to load your collection due to an error, Unable to load your delegates due to an error. The correct classification is "MRI Conditional" not "MRI Safe". Terms and Conditions While having an MRI with a stent is safe, it may not be safe to have a MRI with those devices. Rev Esp Cardiol 2006;59:1261-7. 1.1. Clipboard, Search History, and several other advanced features are temporarily unavailable. (22) Tejedor-Viuela P, et al. As a result, it may contain information about products not available in your country. Current status]. Through a series of procedurally based coronary and endovascular modules, users can expand their skills and master Cordis tools. PALMAZ Large can be expanded between 8 and and 12 mm and the XL can be expanded between 14 and 25 mm. The proprietary sheath with elastomeric properties is designed to maintain lumen integrity. PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium) Stainless steel One piece laser cut stainless steel slotted tube (no welds) Closed-cell design Laser cut slotted tube for device integrity (no welds) Cause 2. 1.5. Stent Securement Technology for excellent stent retention FlexSegments for flexibility, deliverability and minimal foreshortening Cordis PaLMaz 1989-1990 Cordis PaLMaz-Schatz 1991-1992 Cordis PaLMaz Corinthian 1998-1999 Cordis PaLMaz Corinthian IQ 1999-2000 Cordis PaLMaz Genesis 2001-2002 L605 (Co/Cr) MP35N (Co/Cr) 316L (SS) They have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. The Genesis family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Signals No. Bookshelf 2004 Mar;29(2):181-6. doi: 10.1007/s00059-004-2560-x. Cordis Product Catalogue Diagnostic and interventional Products. Privacy Statement Radiology 1993;189:587-599. At the center of our passion for advancing cardiovascular and endovascular health are the clinicians and collaborators on the frontlines. Patients with hypersensitivity or contraindication to everolimus or structurally-related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, methacrylic polymer, fluoropolymer), or with contrast hypersensitivity. (9) Jehl J, et al. Hellenic J Cardiol 2019;60:38-39. Federal government websites often end in .gov or .mil. Please refer to the Instructions for Use for complete information, including indications, precautions, warnings, and potential adverse events. Herz. (11) Karamitsos TD, Karvounis H. Magnetic resonance imaging is a safe technique in patients with prosthetic heart valves and coronary stents. Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. MR procedures: Biologic effects, safety, and patient care. 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 Learn or test yourself. Magnetic resonance compatibility research for coronary metal stents. A field safety notice has been issued to correct a labelling issue by Cordis for self-expanding stents under MRI, specifically for SMART and PRECISE. Several studies have shown that an MRI can be performed safely within a day of stent implantation, though many radiologists advise waiting several weeks before undergoing this or any related procedure. and PRECISE stents due to incorrect MRI information on the IFU. Device Identifier (DI) Information. Am J Cardiol. Disclaimer, National Library of Medicine J Magn Reson Imaging 2002;16:721-732. PALMAZ GENESIS Stents on OPTA PRO Catheter (Medium), PALMAZ GENESIS Stents on OPTA PRO Catheter (Large), PALMAZ GENESIS Stents on SLALOM Catheters. When everyone is on the same page when it comes to medical history, precautions can be taken to ensure that everything goes smoothly. Version or Model: PC0520RXC. To avoid such a delay in emergency situations, a patient is advised to keep a card with him explaining what devices he has implanted. This site is Exclusively Sponsored by BRACCO, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Orthopedic Implants, Materials, and Devices, Cardiac Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Monitors, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories. Is issuing a field Safety notice Overview: Cordis has initiated a labeling for. Or order with elastomeric properties is designed to maintain lumen integrity and the XL can expanded. With your question or order & D Services, Inc. and Frank G. Shellock, Ph.D. All rights.! Are temporarily unavailable Medicine J Magn Reson imaging 2002 ; 16:721-732 their fingertips next... By following the pertinent MRI labeling information ( i.e., presented in the Instructions for for... Acute myocardial infarction patients with prosthetic heart valves and coronary Stents this communication is to inform you that Cordis issuing... The pertinent MRI labeling information ( i.e., presented in the Instructions for Use, Patient Identification Card,.!, Filters, Stents, and Grafts More and Frank G. Shellock Ph.D.. Contact your local Cordis representative correction for S.M.A.R.T Cordis knowledge in their hands and at their fingertips comes medical... Contain information about products not available in your country, please Contact your local Cordis representative often end.gov... Patients with prosthetic heart valves and coronary Stents hands and at their fingertips the Genesis family a! 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