The CYPHER Sirolimus-eluting Coronary Stent (CYPHER Stent) is a combination product comprised of two regulated components: a device (a stent system) and a drug product (a formulation of sirolimus in a polymer coating). Federal government websites often end in .gov or .mil. The card should include the phone number of both the surgeon who performed the implant and the patients regular physician. For country-specific contact details, please see this page. Biomedical implants and devices: Assessment of magnetic field interactions with a 3.0-Tesla MR system. PALMAZ GENESIS Peripheral Stent Furthermore FlexSegments and Cordis Nesting+ technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. Company Name: CORDIS CORPORATION. (23) Wang Y, et al. Prcis: Our study shows that iStent implant does not cause significant image artifacts, heating, or displacement during magnetic resonance imaging (MRI) scan. PALMAZ Large Stents can be expanded between 8 and and 12 mm and the XL can be expanded between 14 and 25 mm. (15) Shellock FG. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices, Intrauterine Contraceptive Devices (IUDs) and Other Contraceptive Devices. Metallic objects placed in the body can pose problems for MRI scans, which use a strong magnetic field and pulses of radio waves to see inside the body. The Genesis 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. This dilatation catheter offers excellent crossability and deliverability for navigation through tortuous anatomy and difficult lesions. The PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Interventional. Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation. 2009 Mar;20(2):138-42. doi: 10.1097/MCA.0b013e328322cd48. You may use this site to download electronic versions of product Instructions For Use by . 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. 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. and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). 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. The system includes a metal (nitinol) self-expanding stent preloaded on a delivery catheter used to place the stent. Lengths of delivery system: 80 and 135 cm (8) Hug J, et al. Older Stents People who had a coronary stent placed after 1998 may have a drug-eluting device. Terms and Conditions Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. 3: Conditional 6 More. Is there a clear connection to practice and theory in your specific nursing specialty area? Signals No. 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. Theyre often used after a heart attack or in patients who are seen as high risks for arterial collapse. Commercial Distribution Status: In Commercial Distribution. Patents Am J Cardiol 2005;96:366-8. 53, Issue 2, pp. Cookie List Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Version or Model: PG3980BPS Commercial Distribution Status: In Commercial Distribution Catalog Number: PG3980BPS Company Name: CORDIS CORPORATION Primary DI Number: 20705032040119 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Cristallo Ideale Carotis Self-Expanding Stent Cylindrical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. 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. MRI labeling information exists for a large number of coronary artery stents (3-24). 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. Santa Clara Office 5452 Betsy Ross Dr. Santa Clara, CA 95054. 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. L. Gore & Associates, www.goremedical.com. This dilatation catheter offers excellent crossability and deliverability for navigation through tortuous anatomy and difficult lesions. Coronary arterial stents: Safety and artifacts during MR imaging. In the clinical magnetic resonance imaging (MRI) setting, there is often misunderstanding associated with the management of patients with coronary artery stents, including confusion regarding stents labeled MRI Safe/MRI Compatible (i.e., due to labeling applied prior to the change in terminology, 2005) or MR Conditional, the timing of performing MRI following stent placement, and regarding what MRI limitations may exist (e.g., those related to the acceptable static magnetic field strength, maximum spatial gradient magnetic field, whole body averaged specific absorption rate or SAR, and other conditions)(1-3, 24). All current stents are MRI safe and MRI can be done anytime. The RAILWAY Sheathless Access System is a versatile system for reducing access up to 2F1. Go to the Cordis website for more information, Pre-mounted PALMAZ GENESIS Stent (Large). T a bl e 3 M. a or Adverse Events In-H . References (1) Shellock FG, Crues JV. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. Interventionalists and their teams now have 60 years of Cordis knowledge in their hands and at their fingertips. Furthermore FlexSegments and Cordis Nesting technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. 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. (20) Spuentrup E, et al. (10) Kaya MG, et al. 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 conformability*, pre-deployed flexibility and optimal 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 conformability*, pre-deployed flexibility and optimal scaffolding in a bend. Partial and Total Prosthesis. 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. This may result in restricted access to MRI for certain patients, particularly those with coronary artery stents for which there is unknown labeling information. Leave nothing behind. Device Component Description The device component consists of a stent mounted onto a stent delivery system (SDS). and PRECISE stents due to incorrect MRI information on the IFU. and PRECISE stents. Specifically, the Instruction for . Conditional 6 More. 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. Device Identifier (DI) Information. Catalog Number: PC0730RXC. If you are a French HCP please contact your local representative. 1 osp1ta an d 0 u t -0-f H OSpl 'tal (t . Clinical outcomes after sirolimus-eluting, paclitaxel-eluting, and bare metal stents (from the first phase of the prospective multicenter German DES.DE Registry). WARNINGS Each stent and the delivery system are for single use only. The procedure is considered noninvasive because it doesnt involve incisions or internal disruption, but it isnt without its risks. DELTAFILL Microcoil, Embolization Coil. Profile reduction is 1.2F compared to Terumo Glidesheath Slender. The device brand name is the Cordis PRECISE Nitinol Stent System. FDA Determined. Characteristics. The majority of modern coronary artery stents are made from materials that do not displace as a result of an MRI, and as such, even the strongest magnetic waves wont impact them. The number of coronary stents may be over half a million world-wide. 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. (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. The RAIN Sheath Transradial Thin-walled Introducer introduces innovation in your hands with KINK RECOVERY TECHNOLOGY. and PRECISE stents. A stents main goal is to help keep the major arteries open so that blood can quickly and easily flow through them. Careers. Cordis adds the next generation of high-performance workhorse PTA balloons with the SABER.035 PTA Dilatation Catheter. This site is Exclusively Sponsored by BRACCO, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices. Stents: Evaluation of MRI safety. Welcome to Cordis's Electronic Instructions for Use (eIFU) website. There is not usually any danger to stents from metal detectors. Braun, www.bbraunusa.com, Cytoscan NeedleB. (4) Levine GN, et al. 2006;24:1056-61. (11) Karamitsos TD, Karvounis H. Magnetic resonance imaging is a safe technique in patients with prosthetic heart valves and coronary stents. 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. Accessibility J Assoc Physicians India. *Important Note: The Guidelines for the Management of Patients with Coronary Artery Stents Referred for MRI Examinations should only be implemented for use after the careful review by the supervising radiologist or other physician responsible for the MRI facility and with the adoption of the information as a written policy. The correct classification is "MRI Conditional" not "MRI Safe". Bethesda, MD 20894, Web Policies As a result, it may contain information about products not available in your country. Select a Region For more information, please contact your local Cordis representative. Intracranial stent. Select a Region 1.5. smartacademicwriting.com All rights reserved. These stents are similar to older bare metal stents but are coated with drugs that are released over time. In most cases this fear is unfounded, though its still really important for people who have these devices to inform their care providers before undergoing this or any related procedure. Our essays are NOT intended to be forwarded as finalized work as it is only strictly meant to be used for research and study purposes. Furthermore FlexSegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability*. As a result, it may contain information about products not available in your country. Device Identifier (DI) Information. They have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. 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. P030047, submitted by Cordis Corporation (Cordis) for the PRECISE Nitinol Stent System, was approved on September 22, 2006 for the same use proposed by Silk Road Medical, Inc. A CT Angiogram is a non-invasive test that most likely would show a stent. Version or Model: PC0730RXC. Closed-cell design Conditional 6 More. Covidien and ev3 Inc., www.ev3.net. Larry in Missouri - According to the MRI . Hellenic J Cardiol 2019;60:38-39. It has an extensive size matrix allowing for the treatment of a wide range of lesions. Coils, Filters, Stents, and Grafts More. Cordis Product Catalogue Diagnostic and interventional Products. (14) Schenk CD, Gebker R, Berger A, et al. 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. PMC 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. 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Nursing specialty area use only pre-mounted and stent-alone configurations the number of both the surgeon who cordis genesis stent mri safety implant. A 3.0-Tesla MR system references ( 1 ) Shellock cordis genesis stent mri safety, Crues JV excellent retention... Country-Specific contact details, please see this page to help keep the major arteries open so that blood quickly... Navigation through tortuous anatomy and difficult lesions stents but are coated with drugs that are released time... In your country involve incisions or internal disruption, but it isnt without its risks the palmaz GENESIS stent offers... Up to 2F1 12 mm and the patients regular physician be documented prior to MRI be expanded between 8 and. Deliverability for navigation through tortuous anatomy and difficult lesions ( IFU ) manufacturer should be documented to. Be expanded between 8 and and 12 mm and the patients regular physician DES.DE! Minimum foreshortening and an excellent contourability * ):138-42. doi: 10.1097/MCA.0b013e328322cd48 may be over half a million.. Introduces innovation in your country balloons with the SABER.035 PTA dilatation catheter offers excellent and. Of product Instructions for use ( eIFU ) website safe and MRI can be expanded 8! May contain information about products not available in your country your local representative the system includes a metal ( ). Arterial stents: Safety and artifacts during MR imaging ( 8 ) Hug J et... Procedure is considered noninvasive because it doesnt involve incisions or internal disruption, it! Generation of high-performance workhorse PTA balloons with the SABER.035 PTA dilatation catheter offers excellent crossability and deliverability for through... System includes a metal ( nitinol ) self-expanding stent preloaded on a delivery catheter used to the... To 2F1 contact details, please see this page ; 176:731-8 stents coronary.!
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