boston scientific epic stent mri safety boston scientific epic stent mri safety

Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. %%EOF 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. Several of these demonstrated magnetic field interactions. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Indicates a trademark of the Abbott group of companies. All rights reserved. MRI Safety Home The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. @Bd!$7@"rAOgx Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Can I undergo MRI or scanner testing with a stent? Boston Scientific, www.bostonscientific.com . 38948-8607. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . 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. Follow the checklist instructions within Merlin PCS Programmer. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. of Abbott Medical Japan GK. Are you a healthcare professional? For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook 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. Conditional 6 More. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. This press release contains forward-looking statements. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. If the stent migrates to the heart, it could cause life-threatening injury. Coils, Filters, Stents, and Grafts More. 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. It is required to program the device to MRI Settings as part of the MRI scan workflow. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 0 Epic Stent Boston Scientific, www.bostonscientific.com. "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. :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\. Search for coronary and peripheral disease and valve disease IFUS. endstream endobj startxref Sterile. 2023 Boston Scientific Corporation or its affiliates. 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. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. 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. }7MWJ!%c. 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. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The product, pouch label and carton label are all correct and the correct DFU is in the package. The .gov means its official.Federal government websites often end in .gov or .mil. If needed, perform capture and sense and lead impedance tests. Use of these devices may cause serious injuries or death. 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. THE List - MRI Safety Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. The Boston Scientific Epic Stent Continues to Demonstrate Positive Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 3: Conditional 6 . 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. This site uses cookies. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Physicians interested in reviewing a complete copy of the revised TAXUS Express2 stent DFU may obtain a copy from the TAXUS website at www.taxus-stent.com. The FDA has identified this as a Class I recall, the most serious type of recall. 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). Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. 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. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. Orthopedic Implants, Materials, and Devices More. IFbj.)D^7TE.V\Bz->/. 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. A stent delivery system for a balloon expandable stent consists Metal Expandable Biliary Stents - Food and Drug Administration 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, Filters, Stents, and Grafts More. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. As the stent is exposed to body temperature it expands to appose the duct wall. PDF Table of Contents - WATCHMAN "The Epic Stent has been very well-received by physicians across the country. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. 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. Drummond wire (316L SS) orthopedic implant. These devices are considered MR Unsafe. If a device is not shown in the list, it is not MR Conditional. 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. Several of these demonstrated magnetic field interactions. Coronary data supports safety of paclitaxel and ELUVIA DES IV. Safety of Magnetic Resonance Imaging in Patients With - Circulation Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. Newmatic Medical, www.newmaticmedical.com. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. 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. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Before sharing sensitive information, make sure you're on a federal government site. 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. The revised Express2 bare-metal stent DFU will be available shortly. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. MR imaging provides excellent spatial . DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t 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. 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. Catalog No. Class 3 Device Recall Sentinol Nitinol Biliary Stent System 38948-8607. 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. You can search by model number or product category. Find products, medical specialty information, and education opportunities. 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. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? 2022 Boston Scientific Corporation or its affiliates. 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. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. %PDF-1.5 % The Epic Stent should not migrate in this MRI environment. GMDN Names and Definitions: Copyright GMDN Agency 2015. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. All other trademarks are the property of their respective owners. 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. Epic Vascular Self-Expanding Stent System - Boston Scientific It was launched in the United States in May of 2012. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. 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 [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. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Marlborough, MA 01752-1566 . Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent Magnetic Resonance MR Conditional 3.0 tesla temperature information For more information, please visit: www.bostonscientific.com. There have been 17 complaints and reported injuries related to this issue. 2*Uax?t} The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. An official website of the United States government, : Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. 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/. %PDF-1.4 % 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. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug An inner shaft, with two radiopaque markers, aids in the placement of the stent. Please be sure to read it. 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.