Boston Scientific 2 Agenda I. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. 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. 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. 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. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Shellock R & D Services, Inc. email: [email protected]. 1.5 . Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. The results found that the stent was MRI . 1.5,3: 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. IFbj.)D^7TE.V\Bz->/. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. MRI safety testing has shown that the REBEL Stent is MR Conditional and that 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. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific, www.bostonscientific.com . Premarket Approval (PMA) %PDF-1.4 % Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). 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. These devices are considered MR Unsafe. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Search for arrhythmia, heart failure and structural heart IFUs. PDF Summary of Safety and Effectiveness Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Before sharing sensitive information, make sure you're on a federal government site. 1) Confirm MRI readiness. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Indicates a trademark of the Abbott group of companies. Can I undergo MRI or scanner testing with a stent? DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Coils, Filters, Stents, and Grafts More. Proper patient monitoring must be provided during the MRI scan. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. 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. 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. Reproduced with Permission from the GMDN Agency. Safe More. 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. Newmatic Medical, www.newmaticmedical.com. Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Sterile. Conditional 6 More. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. THE List - MRI Safety This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep 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. 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. For more information, please visit: www.bostonscientific.com. }7MWJ!%c. MRI Safety Home @Bd!$7@"rAOgx 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. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. 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. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Read our privacy policy to learn more. Use this database for coronary intervention, peripheral intervention and valve repair products. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. 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. MR imaging provides excellent spatial . A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls or other organs. All rights reserved. Follow the checklist instructions within Merlin PCS Programmer. The revised Express2 bare-metal stent DFU will be available shortly. 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. Find out who we are, explore careers at the company, and view our financial performance. 0 Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) This site uses cookies. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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 [?] %%EOF This includes continuous monitoring of the patient's hemodynamic function. MRI Safety for Cardiovascular Products I Abbott 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. Cautionary Statement Regarding Forward-Looking Statements. 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: The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. The information provided here is not intended to provide information to patients and the general public. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 86 0 obj <>/Encrypt 60 0 R/Filter/FlateDecode/ID[<7D8C813C4252734AB79DD3D747A7C1DD><1D49B7B49C69E9479F78B175C988B6B0>]/Index[59 63]/Length 120/Prev 229479/Root 61 0 R/Size 122/Type/XRef/W[1 2 1]>>stream Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. 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. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 %PDF-1.5 % The Sentinol Nitinol Stent System is comprised of two components: the implantable . 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. AccessGUDID - DEVICE: Ascerta (08714729802976) 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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/. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. There have been 17 complaints and reported injuries related to this issue. Drummond wire (316L SS) orthopedic implant. 2*Uax?t} [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. 2023 Boston Scientific Corporation or its affiliates. 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. 121 0 obj <>stream Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. 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. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. AccessGUDID - DEVICE: Tria Soft (08714729959915) An official website of the United States government, : MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. The .gov means its official.Federal government websites often end in .gov or .mil. "The Epic Stent has been very well-received by physicians across the country. Use of these devices may cause serious injuries or death. Our ability to provide a total iliac solution, with the market-leading Express LD Stent and our expansive balloon catheter portfolio, allows Boston Scientific to offer a complete line of advanced solutions to physicians and patients.". By using this site, you consent to the placement of our cookies. Introduction II. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. PDF 2 7 2 Epic Vascular 2 - Boston Scientific The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. 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. Shellock R & D Services, Inc. email: [email protected]. Coronary data supports safety of paclitaxel and ELUVIA DES IV.
Former Wsyx Reporters, Deferred Commission Journal Entry, Liste Des Parc De Maison Mobile En Floride, Queen Of Wands As Feelings, Eagle Springs Golf Club Colorado Membership Cost, Articles B