Coils, Filters, Stents, and Grafts More. This cautionary statement is applicable to all forward-looking statements contained in this document. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. PDF Summary of Safety and Effectivness (SSED)Template Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. All rights reserved. Drummond wire (316L SS) orthopedic implant. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . f@ No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. These devices are considered MR Unsafe. Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. All rights reserved. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. MRI Safety for Cardiovascular Products I Abbott Indicates a third party trademark, which is property of its respective owner. 1.5,3: Conditional 5 More . Dont scan the patient if any adverse conditions are present. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Stents, Drains And Dilators For The Biliary Ducts, Code of Federal Regulations (CFR) Title 21 7.55. Marlborough, MA 01752-1566 . Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. No amputations were reported through the 12-month period. Epic Stent Boston Scientific, www.bostonscientific.com. It is required to program the device to MRI Settings as part of the MRI scan workflow. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. To look up your patient's system, use the Product Search tool to determine whether your patient's device and leads (if applicable) are safe for an MRI. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. 2023 Boston Scientific Corporation or its affiliates. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Disposable devices associated with implantation may be included. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the ORION trial and chairman of the Department of Vascular Surgery at The Cleveland Clinic Foundation, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. For more information, please visit: www.bostonscientific.com. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. THE List - MRI Safety Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Search for coronary and peripheral disease and valve disease IFUS. 2022 Boston Scientific Corporation or its affiliates. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. Can I undergo MRI or scanner testing with a stent? [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, MRI Ready Systems Manual or MRI Ready Leadless System Manual, Interrogate the device with the Merlin PCS Programmer. Immediately following the MRI procedure, follow the instructions in the MRI Ready Systems Manual or MRI Ready Leadless System Manual to revert to the permanently programmed settings. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Enterra II Model 37800Gastric Electrical Stimulation (GES) SystemEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Enterra TherapyGastric Electrical Stimulation (GES) SystemModels 3116 and 7425 GEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Entovis ProMRI Cardiac Pacing SystemWhich consists of the Entovis pulse generator and the Setrox S and Safio S leadsBIOTRONIK, Inc., http://www.biotronikusa.com/manuals/index.cfmNote that the MR Condi, ENTRI-FLEXEntriFlexNasogastric (NG) Feeding TubeCOVIDIENHazelwood, MO, ENTRISTARJejunum Feeding Tube/Gastric Depression TubeCOVIDIENHazelwood, MO, EOI Spinal System EPPS (Expanding Polyaxial Pedicle Screw)Expanding Orthopedics Inc.Israel, EOS (Endoluminal Occlusion System) ImplantMedical Murray, Inc., medicalmurray.com, Epic StentBoston Scientific, www.bostonscientific.com, EpicageAlphatec Spine Inc., www.alphatecspine.com, Episealer Knee CondyleEpisurf Medical AB, www.episurf.com, Equi-Flow Valve System(s)15174, SLRKL, SLSKLL, 15175, SLRKLL,SLSKLM, 15179, SLRKLM, SLSKM, 15185,SLRKM, SLSL, 15549, SLRL, SLSLL,15551, SLRLL, SLSLM, 15552, SLRLM,SLSM, 15554, SLRM, 15181, 15555,SLSKL, Equine Pericardial Patch, Model XAGEdwards Lifesciences, www.edwards.com, EquipLite bladeTruphatek International LTD., www.truphatek.com, ES-830 MicroCutter Green StapleCardica, Inc. and Dextera Surgical, www.dexterasurgical.com, EsophaCoil-SRnitinolcoil, stent, filterIntratherapeutics, Inc.St. Boston Scientific, www.bostonscientific.com . This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to check the MRI scan parameter tables for the applicable scan and identify the settings for RF Transmit Conditions and scan regions. BSC began marketing the product internationally following approval in September 2001. The TAXUS Express2 and Express2 systems were shown to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release. A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details about checking the MRI Settings status with and without the MRI Activator handheld device. Boston Scientific Corporation . Sterile. endstream endobj startxref CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). An official website of the United States government, : The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to see examples of checklist screens and get additional details about the checklist. Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. THE List - MRI Safety The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. The delivery system is compatible with 0.035 in. :V m_C.4c9M/:4"Pp^8r_h_(2KDz]H4{T["y&7xPWe8Iw]rp%c2D|t-++@n 6j.#C\Ks _R]O%[D8Y}[1HshY$7\. Reproduced with Permission from the GMDN Agency. H7YPnf'Sq-. This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples. 86 0 obj <>/Encrypt 60 0 R/Filter/FlateDecode/ID[<7D8C813C4252734AB79DD3D747A7C1DD><1D49B7B49C69E9479F78B175C988B6B0>]/Index[59 63]/Length 120/Prev 229479/Root 61 0 R/Size 122/Type/XRef/W[1 2 1]>>stream The Sentinol Nitinol Stent System is comprised of two components: the implantable . They appreciate the radial force of the stent, which helps allow the artery to stay open, and the flexibility in its design, which helps in deliverability. {}(;]xjx$,&\I'esU7;O*G@MI9YO?V6t N=9nq}^I pk2f5RVw>bd.Ms@G7'^,UPX_4~KO$rS8ILEn5WVu >V:RD/L u 9cwM\^$h IOK #>of=eP V}-St:Ur{>J;{n=b^mZ? Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Epic Vascular Self-Expanding Stent System - Boston Scientific Instructions for Downloading Viewers and Players. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. News Releases - Boston Scientific Our ability to provide a total iliac solution, with the market-leading Express LD Stent and our expansive balloon catheter portfolio, allows Boston Scientific to offer a complete line of advanced solutions to physicians and patients.". MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. If needed, perform capture and sense and lead impedance tests. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook All rights reserved. All other trademarks are the property of their respective owners. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. PDF Table of Contents - WATCHMAN The .gov means its official.Federal government websites often end in .gov or .mil. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. The site is secure. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. Magnetic Resonance MR Conditional 3.0 tesla temperature information About Boston ScientificBoston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. 1 0 obj << /Creator (Venous Wallstent SSED vers 2 - Microsoft Word) /CreationDate (D:20020508130644Z) /Title (P980033) /Author (Author: ODE) /Producer (Acrobat PDFWriter 5.0 for Windows NT) /Subject (Issue: 11-16-2001) /Keywords (Posted: 05-08-2002) /ModDate (D:20020508134926-03'00') >> endobj 2 0 obj [ /PDF /Text ] endobj 3 0 obj << /Pages 60 0 R /Type /Catalog /Metadata 87 0 R >> endobj 4 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 8 0 R /F2 10 0 R /F3 12 0 R >> /ProcSet 2 0 R >> /Contents 14 0 R /Thumb 65 0 R >> endobj 5 0 obj << /Kids [ 4 0 R 16 0 R 21 0 R 27 0 R 30 0 R 36 0 R ] /Count 6 /Type /Pages /Parent 60 0 R >> endobj 6 0 obj << /Type /Font /Subtype /TrueType /Name /F0 /BaseFont /TimesNewRoman 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boston scientific epic stent mri safety