boston scientific epic stent mri safety

Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). 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. 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. Magnetic Resonance MR Conditional 3.0 tesla temperature information Search for coronary and peripheral disease and valve disease IFUS. 121 0 obj <>stream Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . 59 0 obj <> endobj Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. Find out who we are, explore careers at the company, and view our financial performance. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Testing, Training, and Books Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. The results found that the stent was MRI . 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 /FirstChar 32 /LastChar 255 /Widths [ 250 333 408 500 500 833 778 180 333 333 500 564 250 333 250 278 500 500 500 500 500 500 500 500 500 500 278 278 564 564 564 444 921 722 667 667 722 611 556 722 722 333 389 722 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/Descent -220 /Leading 225 /MaxWidth 1043 /AvgWidth 600 >> endobj 14 0 obj << /Length 15 0 R /Filter /FlateDecode >> stream Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Several of these demonstrated magnetic field interactions. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. The stent is constrained within a 6F delivery system. 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. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. There have been 17 complaints and reported injuries related to this issue. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. H7YPnf'Sq-. Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. IFbj.)D^7TE.V\Bz->/. MRI safety testing has shown that the REBEL Stent is MR Conditional and that f@ NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. It was launched in the United States in May of 2012. 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 Epic Stent should not migrate in this MRI environment. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Precautions The site is secure. Catalog No. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook 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. 1.5,3: Conditional 5 More . [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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Search for arrhythmia, heart failure and structural heart IFUs. "The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. 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). It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across a variety of stent sizes. About Epic and the ORION Trial The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. It is required to program the device to MRI Settings as part of the MRI scan workflow. 2022 Boston Scientific Corporation or its affiliates. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. A stent delivery system for a balloon expandable stent consists Epic Stent Boston Scientific, www.bostonscientific.com. hbbd``b` C9E tk`/@PHA,HyM! endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. If the stent migrates to the heart, it could cause life-threatening injury. 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. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. The MRI parameter settings are selected at the physician's discretion. Conditional 6 More. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. @Bd!$7@"rAOgx Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Device setup, user manuals and troubleshooting, (April 5, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS Express, Lab Agent - Restock Products For Your Practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861775 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. As the stent is exposed to body temperature it expands to appose the duct wall. 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. Please be sure to read it. With our stent systems, MRI analyses can now be performed immediately.". This includes continuous monitoring of the patient's hemodynamic function. Marlborough, MA 01752-1566 . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and outcomes, our technology, product performance and importance, and competitive offerings. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. Newmatic Medical, www.newmaticmedical.com. 2*Uax?t} The information provided here is not intended to provide information to patients and the general public. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . This site uses cookies. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 12-month Primary Patency by TASC Classification, See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Epic Vascular Self-Expanding Stent System, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, 0 amputations at 3 years (106 subjects), ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications, Tandem Architecture Stent Design features Macro, Medium and Micro Struts, as well as patented connector patternsdesigned to optimize flexibility, Hybrid Architecture Design with open- and closed-cell geometry engineered to provide flexibility and deployment uniformity, Macro and Micro Struts are engineered to work in tandem for balanced forceeven in tortuous vasculature, Ergonomic handle with two convenient deployment options: thumb wheel and pull grip, Radiopaque stent markers and catheter shaft marker band enhance visibility and simplify placement, Meticulous surface finishing and polishing to remove imperfections and improve fracture resistance, Tandem Architecture Stent Design engineered to bend and flex and reduce the risk of fracture, 0% Amputation of index limb at 12-months (0/111).

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