boston scientific epic stent mri safety

PDF Summary of Safety and Effectiveness Data (Ssed) The Sentinol Nitinol Stent System is comprised of two components: the implantable . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. 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. All rights reserved. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details about checking the MRI Settings status with and without the MRI Activator handheld device. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE 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. %%EOF Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. All other trademarks are the property of their respective owners. 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. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. AccessGUDID - DEVICE: Tria Soft (08714729959915) Dry Pad 9 x 9 with Silver Antimicrobial Agent. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. With our stent systems, MRI analyses can now be performed immediately.". Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). 0 The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 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. 2022 Boston Scientific Corporation or its affiliates. hbbd``b` C9E tk`/@PHA,HyM! Catalog No. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. 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. Metal Expandable Biliary Stents - Food and Drug Administration This includes continuous monitoring of the patient's hemodynamic function. Dont scan the patient if any adverse conditions are present. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. As the stent is exposed to body temperature it expands to appose the duct wall. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Indicates a third party trademark, which is property of its respective owner. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Premarket Approval (PMA) Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. No amputations were reported through the 12-month period. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Several of these demonstrated magnetic field interactions. Catalog No. 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). It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. MRI Safety Home Device setup, user manuals and troubleshooting, (April 5, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS Express, 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. 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). All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details on default settings and how to save modified settings for scanning. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . Marlborough, MA 01752-1566 . %PDF-1.5 % 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. 121 0 obj <>stream Coronary data supports safety of paclitaxel and ELUVIA DES IV. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. IFbj.)D^7TE.V\Bz->/. PDF Summary of Safety and Effectivness (SSED)Template Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The FDA has identified this as a Class I recall, the most serious type of recall. 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. 5-year data for. of Abbott Medical Japan GK. 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).? 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. "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.". 300 Boston Scientific Way . 59 0 obj <> endobj Safe More. 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. It was launched in the United States in May of 2012. 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 Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . 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. 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 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. 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 default MRI parameter settings are automatically stored in the Abbott MR Conditional device. 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. Class 3 Device Recall Sentinol Nitinol Biliary Stent System Alternatively, you can also use the latest MRI Manuals to determine scan parameters. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. (0.89mm) guidewires. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. PDF Summary of Safety and Effectiveness 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. 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.