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. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. No deaths have been reported. 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. By using this site, you consent to the placement of our cookies. Disposable devices associated with implantation may be included. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. 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. Can I undergo MRI or scanner testing with a stent? 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 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. Use this database for coronary intervention, peripheral intervention and valve repair products. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Duplex ultrasound, which measures blood flow through arteries and veins, showed a primary patency (level of un-obstruction) of 94.4 percent, indicating the vast majority of treated lesions remained open through the 12-month follow-up period. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook No amputations were reported through the 12-month period. 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/. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. 0
If the stent migrates to the heart, it could cause life-threatening injury. Are you a healthcare professional? Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Indicates a trademark of the Abbott group of companies. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 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 [?] Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support.
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. Coils, Filters, Stents, and Grafts More. 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. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. 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 :V
m_C.4c9M/:4"Pp^8r_h_(2KDz]H4{T["y&7xPWe8Iw]rp%c2D|t-++@n 6j.#C\Ks
_R]O%[D8Y}[1HshY$7\. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t
Dont scan the patient if any adverse conditions are present. Newmatic Medical, www.newmaticmedical.com. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
About Epic and the ORION Trial The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement.
Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes PDF Table of Contents - WATCHMAN Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples.
PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. There have been 17 complaints and reported injuries related to this issue. {}(;]xjx$,&\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? H7YPnf'Sq-. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission. Marlborough, MA 01752-1566 . f@ Please be sure to read it. 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. 2*Uax?t}
MRI Safety Home The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system.
News Releases - Boston Scientific Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 300 Boston Scientific Way . AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 0.3. With our stent systems, MRI analyses can now be performed immediately.". This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. 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: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Proper patient monitoring must be provided during the MRI scan. endstream
endobj
startxref
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
Georgia Foraging Laws,
In The First Sentence Of The Sixth Paragraph,
Articles B