Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Search for coronary and peripheral disease and valve disease IFUS. "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.". The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. If the stent migrates to the heart, it could cause life-threatening injury. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." Please be sure to read it. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. 59 0 obj <> endobj Use this database for coronary intervention, peripheral intervention and valve repair products. Sterile. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. "The Epic Stent has been very well-received by physicians across the country. Applicant's Name and Address: Boston Scientific Scimed Inc. One Scimed Place Maple Grove MN 55311-1566 PMA Number: P980033 Date of Notice of Approval to the Applicant: Novermber 16, 2001 2. This cautionary statement is applicable to all forward-looking statements contained in this document. 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. 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 [?] 5-year data for. 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. 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. The Boston Scientific Epic Stent Continues to Demonstrate Positive @Bd!$7@"rAOgx The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. Read our privacy policy to learn more. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. 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. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Introduction II. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel Reproduced with Permission from the GMDN Agency. Indicates a third party trademark, which is property of its respective owner. The information provided here is not intended to provide information to patients and the general public. All rights reserved. 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. 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. 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. 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. By using this site, you consent to the placement of our cookies. f@ The Epic Stent should not migrate in this MRI environment. Dont scan the patient if any adverse conditions are present. 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). Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. Safe More. 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. CAUTION: These products are intended for use by or under the direction of a physician. 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). DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug Refer to the . 1) Confirm MRI readiness. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. {}(;]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? Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 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. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. Find products, medical specialty information, and education opportunities. AccessGUDID - DEVICE: Epic Vascular (08714729805014) The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. MRI Safety for Cardiovascular Products I Abbott This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. 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). 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 Magnetic Resonance MR Conditional 3.0 tesla temperature information %PDF-1.4 % MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. PDF Summary of Safety and Effectiveness Data (Ssed) 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. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes 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. MRI safety testing has shown that the REBEL Stent is MR Conditional and that The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 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 [?] Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Before sharing sensitive information, make sure you're on a federal government site. Search for arrhythmia, heart failure and structural heart IFUs. An official website of the United States government, : The FDA has identified this as a Class I recall, the most serious type of recall. If needed, perform capture and sense and lead impedance tests. With our stent systems, MRI analyses can now be performed immediately.". 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. 2022 Boston Scientific Corporation or its affiliates. MRI Safety Home No deaths have been reported. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Follow the checklist instructions within Merlin PCS Programmer. H7YPnf'Sq-. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. The stent is constrained within a 6F delivery system. An inner shaft, with two radiopaque markers, aids in the placement of the stent. %PDF-1.5 % Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. For more information, please visit: www.bostonscientific.com. Orthopedic Implants, Materials, and Devices More. 38948-8607. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. THE List - MRI Safety 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. 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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 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 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.". 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. :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\. 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. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Indicates a trademark of the Abbott group of companies. 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. (0.89mm) guidewires. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Marlborough, MA 01752-1566 . Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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). 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. 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. 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 For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) 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. MR imaging provides excellent spatial . ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Proper patient monitoring must be provided during the MRI scan. Can I undergo MRI or scanner testing with a stent? 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. Fortunately, the devices that exhibited po . (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 AccessGUDID - DEVICE: Ascerta (08714729802976) Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Catalog No. 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. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Several of these demonstrated magnetic field interactions.