MR imaging provides excellent spatial . The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Overview of the ELUVIA Drug- Eluting Stent (DES) III. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . 2023 Boston Scientific Corporation or its affiliates. 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 All rights reserved. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Note: If you need help accessing information in different file formats, see As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 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 [?] %PDF-1.5 % 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 site is Exclusively Sponsored by BRACCO. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. 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. Proper patient monitoring must be provided during the MRI scan. 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. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. endstream endobj startxref Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . %PDF-1.4 % Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. A stent delivery system for a balloon expandable stent consists The .gov means its official.Federal government websites often end in .gov or .mil. Use this database for coronary intervention, peripheral intervention and valve repair products. Boston Scientific, www.bostonscientific.com . An inner shaft, with two radiopaque markers, aids in the placement of the stent. 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. These devices are considered MR Unsafe. 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. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. You can search by model number or product category. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. 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 [?] 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. It was launched in the United States in May of 2012. 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. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2022 Boston Scientific Corporation or its affiliates. This includes continuous monitoring of the patient's hemodynamic function. This site uses cookies. There have been 17 complaints and reported injuries related to this issue. All rights reserved. The Epic Stent should not migrate in this MRI environment. Introduction II. 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. 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). 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. IFbj.)D^7TE.V\Bz->/. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Follow the checklist instructions within Merlin PCS Programmer. Conditional 6 More. The information provided here is not intended to provide information to patients and the general public. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Several of these demonstrated magnetic field interactions. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t Coils, Filters, Stents, and Grafts More. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. 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. 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. Dont scan the patient if any adverse conditions are present. "The positive 12-month data from the ORION trial complement our early launch success and market share gains," said Jeff Mirviss, president of Peripheral Interventions at Boston Scientific. 59 0 obj <> endobj MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Refer to the . 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. 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. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. MRI safety testing has shown that the REBEL Stent is MR Conditional and that The MRI parameter settings are selected at the physician's discretion. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. If a device is not shown in the list, it is not MR Conditional. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. You can search by product, model number, category or family. "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. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. For more information, please visit: www.bostonscientific.com. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . %%EOF A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. 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. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. HWnFC=ji6n 9/~\:\$$rxnsU,)Ielo((a,$4bY?W7)MoQEHk1s-;]zXJ$G=0.F4VJYwS|U9VOU@n0ZL26w~+y38.$qW|%-zu'2g:,IwA28nvnP R%ivTpks5>/m5p)H,!HIsqz 9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? 0.3. Coronary data supports safety of paclitaxel and ELUVIA DES IV. Please be sure to read it. 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. Indicates a third party trademark, which is property of its respective owner. VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See Medical Device Recall Database Entry Distribution Dates: September 21, 2018 to April 9, 2021 Precautions 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. Sterile. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 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. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. 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. @Bd!$7@"rAOgx If needed, perform capture and sense and lead impedance tests. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . 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 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. Search for coronary and peripheral disease and valve disease IFUS. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. An official website of the United States government, : 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 of Abbott Medical Japan GK. Coils, Filters, Stents, and Grafts More. Use of these devices may cause serious injuries or death. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Read our privacy policy to learn more. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) This press release contains forward-looking statements. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. 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 VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? 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: 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. 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. 0 Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 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. Search for arrhythmia, heart failure and structural heart IFUs. 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/. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 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 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. 5-year data for. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729959915 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent With Side Holes 6Fx28CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers No amputations were reported through the 12-month period. 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. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The product, pouch label and carton label are all correct and the correct DFU is in the package. 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. If the stent migrates to the heart, it could cause life-threatening injury. 38948-8607. "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.".
boston scientific epic stent mri safety
01. jul