375 Chicken 'n Fries Calories,
Side Effects Of Stent In Groin,
Statue Of A Victorious Youth Formal Analysis,
Articles B
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. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. 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. Note: If you need help accessing information in different file formats, see
No amputations were reported through the 12-month period. Can I undergo MRI or scanner testing with a stent? %PDF-1.4
%
Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . The delivery system is compatible with 0.035 in. 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. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Are you a healthcare professional? 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 No deaths have been reported. All other trademarks are the property of their respective owners. Safe More. Please be sure to read it. 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). hbbd``b` C9E tk`/@PHA,HyM! Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. %PDF-1.5
%
endstream
endobj
startxref
As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely. As the stent is exposed to body temperature it expands to appose the duct wall. If needed, perform capture and sense and lead impedance tests. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Major adverse events are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. 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. 1.5,3: The Epic Stent should not migrate in this MRI environment. 300 Boston Scientific Way . It was launched in the United States in May of 2012. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Conditional 6 More. Boston Scientific 2 Agenda I. Magnetic Resonance MR Conditional 3.0 tesla temperature information Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Several of these demonstrated magnetic field interactions. 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 MRI parameter settings are selected at the physician's discretion. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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
The .gov means its official.Federal government websites often end in .gov or .mil. [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. 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 [?] All rights reserved. 2023 Boston Scientific Corporation or its affiliates. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. GMDN Preferred Term Name GMDN Definition; Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. 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. 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). Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. 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 includes continuous monitoring of the patient's hemodynamic function. Introduction II. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . The FDA has identified this as a Class I recall, the most serious type of recall. Search for arrhythmia, heart failure and structural heart IFUs. The Sentinol Nitinol Stent System is comprised of two components: the implantable . Catalog No. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Boston Scientific Corporation . Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . 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. 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. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. 121 0 obj
<>stream
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. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. 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 VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. Indicates a third party trademark, which is property of its respective owner. For more information, please visit: www.bostonscientific.com. 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