Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. The site is secure. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Several of these demonstrated magnetic field interactions. Catalog No. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. If the stent migrates to the heart, it could cause life-threatening injury. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Coils, Filters, Stents, and Grafts More. 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. All other trademarks are the property of their respective owners. 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: This cautionary statement is applicable to all forward-looking statements contained in this document. 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. These devices are considered MR Unsafe. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. {}(;]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? Several of these demonstrated magnetic field interactions. Conditional 6 More. With our stent systems, MRI analyses can now be performed immediately.". The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 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. This includes continuous monitoring of the patient's hemodynamic function. Drummond wire (316L SS) orthopedic implant. 2*Uax?t} 0.3. Device setup, user manuals and troubleshooting, The Boston Scientific Epic Stent Continues to Demonstrate Positive Clinical Outcomes for Patients with Iliac Artery Disease, Twelve-Month Data Presented at TCT 2012 Support Safety and Efficacy of Epic Stent in Iliac Stenting, 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. hbbd``b` C9E tk`/@PHA,HyM! 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. 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. The stent is constrained within a 6F delivery system. Safe More. 3: Conditional 6 . One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Instructions for Downloading Viewers and Players. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Boston Scientific 2 Agenda I. 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. of Abbott Medical Japan GK. By using this site, you consent to the placement of our cookies. If a device is not shown in the list, it is not MR Conditional. 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. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. 121 0 obj <>stream }7MWJ!%c. "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. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). This press release contains forward-looking statements. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. 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. 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 The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. 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. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. 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 Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. H7YPnf'Sq-. Coronary data supports safety of paclitaxel and ELUVIA DES IV. @Bd!$7@"rAOgx Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. For more information, please visit: www.bostonscientific.com. There have been 17 complaints and reported injuries related to this issue. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. 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. The results found that the stent was MRI . Use of these devices may cause serious injuries or death. Are you a healthcare professional? Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . 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. 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. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Before sharing sensitive information, make sure you're on a federal government site. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. If you are not using the MRI Activator, MRI Settings must be disabled by the patient's device management physician or clinician using the Merlin PCS Programmer and Aveir Link Module (if applicable). Magnetic Resonance MR Conditional 3.0 tesla temperature information Read our privacy policy to learn more. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI.