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). If a device is not shown in the list, it is not MR Conditional. All rights reserved. Before sharing sensitive information, make sure you're on a federal government site. Magnetic Resonance MR Conditional 3.0 tesla temperature information We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Are you a healthcare professional? 1.5 . 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. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The FDA has identified this as a Class I recall, the most serious type of recall. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. The product, pouch label and carton label are all correct and the correct DFU is in the package. Reproduced with Permission from the GMDN Agency. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Please be sure to read it. 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. Search for coronary and peripheral disease and valve disease IFUS. 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 [ 250 333 408 500 500 833 778 180 333 333 500 564 250 333 250 278 500 500 500 500 500 500 500 500 500 500 278 278 564 564 564 444 921 722 667 667 722 611 556 722 722 333 389 722 611 889 722 722 556 722 667 556 611 722 722 944 722 722 611 333 278 333 469 500 333 444 500 444 500 444 333 500 500 278 278 500 278 778 500 500 500 500 333 389 278 500 500 722 500 500 444 480 200 480 541 778 500 778 333 500 444 1000 500 500 333 1000 556 333 889 778 611 778 778 333 333 444 444 350 500 1000 333 980 389 333 722 778 444 722 250 333 500 500 500 500 200 500 333 760 276 500 564 333 760 500 400 549 300 300 333 576 453 250 333 300 310 500 750 750 750 444 722 722 722 722 722 722 889 667 611 611 611 611 333 333 333 333 722 722 722 722 722 722 722 564 722 722 722 722 722 722 556 500 444 444 444 444 444 444 667 444 444 444 444 444 278 278 278 278 500 500 500 500 500 500 500 549 500 500 500 500 500 500 500 500 ] /Encoding /WinAnsiEncoding /FontDescriptor 7 0 R >> endobj 7 0 obj << /Type /FontDescriptor /FontName /TimesNewRoman /Flags 34 /FontBBox [ -250 -216 1166 1000 ] /MissingWidth 324 /StemV 73 /StemH 73 /ItalicAngle 0 /CapHeight 891 /XHeight 446 /Ascent 891 /Descent -216 /Leading 149 /MaxWidth 972 /AvgWidth 401 >> endobj 8 0 obj << /Type /Font /Subtype /TrueType /Name /F1 /BaseFont /TimesNewRoman,Bold /FirstChar 32 /LastChar 255 /Widths [ 250 333 555 500 500 1000 833 278 333 333 500 570 250 333 250 278 500 500 500 500 500 500 500 500 500 500 333 333 570 570 570 500 930 722 667 722 722 667 611 778 778 389 500 778 667 944 722 778 611 778 722 556 667 722 722 1000 722 722 667 333 278 333 581 500 333 500 556 444 556 444 333 500 556 278 333 556 278 833 556 500 556 556 444 389 333 556 500 722 500 500 444 394 220 394 520 778 500 778 333 500 500 1000 500 500 333 1000 556 333 1000 778 667 778 778 333 333 500 500 350 500 1000 333 1000 389 333 722 778 444 722 250 333 500 500 500 500 220 500 333 747 300 500 570 333 747 500 400 549 300 300 333 576 540 250 333 300 330 500 750 750 750 500 722 722 722 722 722 722 1000 722 667 667 667 667 389 389 389 389 722 722 778 778 778 778 778 570 778 722 722 722 722 722 611 556 500 500 500 500 500 500 722 444 444 444 444 444 278 278 278 278 500 556 500 500 500 500 500 549 500 556 556 556 556 500 556 500 ] /Encoding /WinAnsiEncoding /FontDescriptor 9 0 R >> endobj 9 0 obj << /Type /FontDescriptor /FontName /TimesNewRoman,Bold /Flags 16418 /FontBBox [ -250 -216 1172 1000 ] /MissingWidth 325 /StemV 136 /StemH 136 /ItalicAngle 0 /CapHeight 891 /XHeight 446 /Ascent 891 /Descent -216 /Leading 149 /MaxWidth 977 /AvgWidth 427 >> endobj 10 0 obj << /Type /Font /Subtype /TrueType /Name /F2 /BaseFont /ArialBlack /FirstChar 32 /LastChar 255 /Widths [ 333 333 500 660 667 1000 889 278 389 389 556 660 333 333 333 278 667 667 667 667 667 667 667 667 667 667 333 333 660 660 660 611 740 778 778 778 778 722 667 833 833 389 667 833 667 944 833 833 722 833 778 722 722 833 778 1000 778 778 722 389 278 389 660 500 333 667 667 667 667 667 389 667 667 333 333 667 333 1000 667 667 667 667 444 611 444 667 611 944 667 611 556 389 278 389 660 750 667 750 278 667 500 1000 667 667 333 1000 722 333 1000 750 722 750 750 278 278 500 500 500 500 1000 333 950 611 333 1000 750 556 778 333 333 667 667 660 667 278 667 333 800 400 667 660 333 800 500 400 660 400 400 333 667 850 333 333 400 400 667 1000 1000 1000 611 778 778 778 778 778 778 1000 778 722 722 722 722 389 389 389 389 778 833 833 833 833 833 833 660 833 833 833 833 833 778 722 667 667 667 667 667 667 667 1000 667 667 667 667 667 333 333 333 333 667 667 667 667 667 667 667 660 667 667 667 667 667 611 667 611 ] /Encoding /WinAnsiEncoding /FontDescriptor 11 0 R >> endobj 11 0 obj << /Type /FontDescriptor /FontName /ArialBlack /Flags 32 /FontBBox [ -250 -310 1200 1101 ] /MissingWidth 389 /StemV 100 /StemH 100 /ItalicAngle 0 /CapHeight 1101 /XHeight 551 /Ascent 1101 /Descent -310 /Leading 410 /MaxWidth 1000 /AvgWidth 552 >> endobj 12 0 obj << /Type /Font /Subtype /TrueType /Name /F3 /BaseFont /Symbol /FirstChar 30 /LastChar 255 /Widths [ 600 600 250 333 713 500 549 833 778 439 333 333 500 549 250 549 250 278 500 500 500 500 500 500 500 500 500 500 278 278 549 549 549 444 549 722 667 722 612 611 763 603 722 333 631 722 686 889 722 722 768 741 556 592 611 690 439 768 645 795 611 333 863 333 658 500 500 631 549 549 494 439 521 411 603 329 603 549 549 576 521 549 549 521 549 603 439 576 713 686 493 686 494 480 200 480 549 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 620 247 549 167 713 500 753 753 753 753 1042 987 603 987 603 400 549 411 549 549 713 494 460 549 549 549 549 1000 603 1000 658 823 686 795 987 768 768 823 768 768 713 713 713 713 713 713 713 768 713 790 790 890 823 549 250 713 603 603 1042 987 603 987 603 494 329 790 790 786 713 384 384 384 384 384 384 494 494 494 494 600 329 274 686 686 686 384 384 384 384 384 384 494 494 494 600 ] /FontDescriptor 13 0 R >> endobj 13 0 obj << /Type /FontDescriptor /FontName /Symbol /Flags 6 /FontBBox [ -250 -220 1252 1005 ] /MissingWidth 333 /StemV 109 /StemH 109 /ItalicAngle 0 /CapHeight 1005 /XHeight 503 /Ascent 1005 /Descent -220 /Leading 225 /MaxWidth 1043 /AvgWidth 600 >> endobj 14 0 obj << /Length 15 0 R /Filter /FlateDecode >> stream Alternatively, you can also use the latest MRI Manuals to determine scan parameters. 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. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). of Abbott Medical Japan GK. No deaths have been reported. 59 0 obj <> endobj Search for arrhythmia, heart failure and structural heart IFUs. This includes continuous monitoring of the patient's hemodynamic function. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. Sterile. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. 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. The information provided here is not intended to provide information to patients and the general public. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. To look up your patients system, use the Product Search tool to determine whether your patients device and leads (if applicable) are safe for an MRI. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. GMDN Names and Definitions: Copyright GMDN Agency 2015. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 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. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. 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. 38948-8607. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. The Sentinol Nitinol Stent System is comprised of two components: the implantable . A Boston Scientific Study of the Epic Self-Expanding Nitonol Stent System in the treatment of Atherosclerotic Lesions in Iliac Arteries 0 amputations at 3 years (106 subjects) 89.9% Freedom from TLR at 3 years (143 lesions) ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. The revised Express2 bare-metal stent DFU will be available shortly. A stent delivery system for a balloon expandable stent consists The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Precautions Instructions for Downloading Viewers and Players. The trial previously met its primary endpoint of major adverse events (MAE) at nine months with a rate of 3.4 percent for the Epic Stent compared to a pre-specified performance goal. On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to: Customers with questions should contact their Boston Scientific sales representative. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. 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). MRI safety testing has shown that the REBEL Stent is MR Conditional and that Safe More. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. Ideal for the Iliac: The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. 2022 Boston Scientific Corporation or its affiliates. Dont scan the patient if any adverse conditions are present. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. All other trademarks are the property of their respective owners. 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. As the stent is exposed to body temperature it expands to appose the duct wall. Follow the checklist instructions within Merlin PCS Programmer. The .gov means its official.Federal government websites often end in .gov or .mil. :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\. Can I undergo MRI or scanner testing with a stent? 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. 3: Conditional 6 . Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. Orthopedic Implants, Materials, and Devices More. Sterile. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. 38948-8607. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details on default settings and how to save modified settings for scanning. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. Boston Scientific 2 Agenda I. 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration, VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System, Distribution Dates: September 21, 2018 to April 9, 2021, Health care providers using the VICI VENOUS STENT System and VICI RDS VENOUS STENT System, Patients who have a procedure using the VICI VENOUS STENT System or VICI RDS VENOUS STENT System, Immediately discontinue use of the device, Remove all affected units from inventory and secure them, Complete the company's Verification Form to acknowledge receipt and report products that will be returned, Package affected products for shipping and contact the local Boston Scientific representative to arrange for their return. The Boston Scientific ELUVIA Drug-Eluting Vascular Stent System is a medical device containing an ancillary medicinal substance, which provides a mechanical scaffold for vascular lumen support (the stent component) and a pharmacological agent (paclitaxel) targeted towards reducing the injury response that leads to restenosis after It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. This cautionary statement is applicable to all forward-looking statements contained in this document. This press release contains forward-looking statements. "The performance of the Epic Stent in challenging iliac artery lesions and the long-term demonstration of both safety and efficacy of the Epic Stent is another example of our ability to offer patients a durable treatment option for iliac artery disease.". Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . HWnFC=ji6n 9/~\:\$$rxnsU,)Ielo((a,$4bY?W7)MoQEHk1s-;]zXJ$G=0.F4VJYwS|U9VOU@n0ZL26w~+y38.$qW|%-zu'2g:,IwA28nvnP R%ivTpks5>/m5p)H,!HIsqz 9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. You can search by product, model number, category or family. epic vascular self-expanding stent system: Boston Scientific Corp. P110035 S045: 04/03/2018: memorygel silicone gel-filled breast implants: MENTOR CORP. P030053 S045: 01/30/2018: reflection ceramic acetabular hip system: Smith & Nephew, Inc. P030022 S045: May be removed prior to MRI and replaced after the MRI exam. Following is some high-level information about preparing for and administering an MRI with patients with a leadless pacemaker, traditional pacemaker, ICD, CRT-D or CRT-P. Use this database for coronary intervention, peripheral intervention and valve repair products. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. hbbd``b` C9E tk`/@PHA,HyM! Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.
Former Rutgers Baseball Coach,
Whitefish School District Superintendent,
Bodacious Bbq Shreveport Menu,
Dor Its Payments Indorits,
Articles B
