Several of these demonstrated magnetic field interactions. PDF Summary of Safety and Effectiveness Data (Ssed) 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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. 2022 Boston Scientific Corporation or its affiliates. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) The delivery system is compatible with 0.035 in. 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. MRI Safety for Cardiovascular Products I Abbott The Boston Scientific Epic Stent Continues to Demonstrate Positive Catalog No. Instructions for Downloading Viewers and Players. 300 Boston Scientific Way . "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. [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. If a device is not shown in the list, it is not MR Conditional. 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. 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. Metal Expandable Biliary Stents - Food and Drug Administration hbbd``b` C9E tk`/@PHA,HyM! Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Introduction II. 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 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. 38948-8607. The revised Express2 bare-metal stent DFU will be available shortly. No amputations were reported through the 12-month period. 1.5,3: We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Read our privacy policy to learn more. Search for arrhythmia, heart failure and structural heart IFUs. %PDF-1.4
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All other trademarks are the property of their respective owners. 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. The information provided here is not intended to provide information to patients and the general public. 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. 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 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. Sterile. Epic Stent Boston Scientific, www.bostonscientific.com. Indicates a third party trademark, which is property of its respective owner. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. Reproduced with Permission from the GMDN Agency. For more information, please visit: www.bostonscientific.com. For more information, please visit: www.bostonscientific.com. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. AccessGUDID - DEVICE: Ascerta (08714729802976) Premarket Approval (PMA) The Sentinol Nitinol Stent System is comprised of two components: the implantable . 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 MRI parameter settings are selected at the physician's discretion. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. 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. Precautions
It was launched in the United States in May of 2012. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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. 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. These devices are considered MR Unsafe.
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.". 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes It is required to program the device to MRI Settings as part of the MRI scan workflow. Use this database for arrhythmia, heart failure and structural heart products. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. This site is Exclusively Sponsored by BRACCO. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 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.