boston scientific epic stent mri safetyboston scientific epic stent mri safety

Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The .gov means its official.Federal government websites often end in .gov or .mil. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 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. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). For more information, please visit: www.bostonscientific.com. May be removed prior to MRI and replaced after the MRI exam. 1.5,3: Please be sure to read it. Epic Stent Boston Scientific, www.bostonscientific.com. endstream endobj startxref Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. THE List - MRI Safety The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. 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 THE List - MRI Safety 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. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. Dont scan the patient if any adverse conditions are present. 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. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Disposable devices associated with implantation may be included. Orthopedic Implants, Materials, and Devices More. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The delivery system is compatible with 0.035 in. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel of Abbott Medical Japan GK. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. Use of these devices may cause serious injuries or death. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. 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 All other trademarks are the property of their respective owners. Follow the checklist instructions within Merlin PCS Programmer. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. 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. All rights reserved. Class 3 Device Recall Sentinol Nitinol Biliary Stent 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. This site uses cookies. Sterile. If a device is not shown in the list, it is not MR Conditional. Find products, medical specialty information, and education opportunities. CAUTION: These products are intended for use by or under the direction of a physician. 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. 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. 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. 38948-8607. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. AccessGUDID - DEVICE: Ascerta (08714729802976) 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. For more information, please visit: www.bostonscientific.com. 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. PDF Table of Contents - WATCHMAN 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. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. The site is secure. hbbd``b` C9E tk`/@PHA,HyM! Introduction II. 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. With our stent systems, MRI analyses can now be performed immediately.". These devices are considered MR Unsafe. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Reproduced with Permission from the GMDN Agency. Before sharing sensitive information, make sure you're on a federal government site. Search for coronary and peripheral disease and valve disease IFUS. 300 Boston Scientific Way . }7MWJ!%c. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. The MRI parameter settings are selected at the physician's discretion. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug 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). Are you a healthcare professional? Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Proper patient monitoring must be provided during the MRI scan. Coils, Filters, Stents, and Grafts More. You can search by model number or product category. Search for arrhythmia, heart failure and structural heart IFUs. IFbj.)D^7TE.V\Bz->/. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE 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. %PDF-1.4 % Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. 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 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 [?] (0.89mm) guidewires. 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. 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. 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 f@ Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . Indicates a third party trademark, which is property of its respective owner. The Epic Stent should not migrate in this MRI environment. 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. Refer to the . The Boston Scientific Epic Stent Continues to Demonstrate Positive 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). The product, pouch label and carton label are all correct and the correct DFU is in the package. 2023 Boston Scientific Corporation or its affiliates. Indicates a trademark of the Abbott group of companies. 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. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. Cautionary Statement Regarding Forward-Looking Statements. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 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. This site is Exclusively Sponsored by BRACCO. THE List - MRI Safety Several of these demonstrated magnetic field interactions. 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. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. MRI Safety Home Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. The information provided here is not intended to provide information to patients and the general public. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. 38948-8607. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. 0.3. The Sentinol Nitinol Stent System is comprised of two components: the implantable . The FDA has identified this as a Class I recall, the most serious type of recall. This cautionary statement is applicable to all forward-looking statements contained in this document. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. 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). 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.". The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. 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. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Instructions for Downloading Viewers and Players. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. MR imaging provides excellent spatial . A stent delivery system for a balloon expandable stent consists Newmatic Medical, www.newmaticmedical.com. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Find out who we are, explore careers at the company, and view our financial performance. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Use this database for arrhythmia, heart failure and structural heart products. %PDF-1.5 % Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. :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 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. Coils, Filters, Stents, and Grafts More. 2*Uax?t} We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Precautions The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is constrained within a 6F delivery system. 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. Class 3 Device Recall Sentinol Nitinol Biliary Stent System News Releases - Boston Scientific Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting .
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