Several of these demonstrated magnetic field interactions. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." hbbd``b` C9E tk`/@PHA,HyM! 59 0 obj <> endobj Search for arrhythmia, heart failure and structural heart IFUs. Proper patient monitoring must be provided during the MRI scan. Find out who we are, explore careers at the company, and view our financial performance. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. 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. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Catalog No. This includes continuous monitoring of the patient's hemodynamic function. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. 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. The delivery system is compatible with 0.035 in. An official website of the United States government, : Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. No deaths have been reported. Please be sure to read it. Class 3 Device Recall Sentinol Nitinol Biliary Stent System of Abbott Medical Japan GK. 1.5,3: Conditional 5 More . Introduction II. 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 Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. THE List - MRI Safety Disposable devices associated with implantation may be included. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Epic Vascular Self-Expanding Stent System - Boston Scientific Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 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.". 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. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. 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. 2023 Boston Scientific Corporation or its affiliates. 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. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. 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 "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.". Instructions for Downloading Viewers and Players. 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. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. All rights reserved. PDF Table of Contents - WATCHMAN 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. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) THE List - MRI Safety (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 Use this database for arrhythmia, heart failure and structural heart products. 38948-8607. The results found that the stent was MRI . 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 cautionary statement is applicable to all forward-looking statements contained in this document. Premarket Approval (PMA) You can search by model number or product category. Safe More. 1.5,3: The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. The revised Express2 bare-metal stent DFU will be available shortly. 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. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. BSC began marketing the product internationally following approval in September 2001. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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. All other trademarks are the property of their respective owners. The MRI parameter settings are selected at the physician's discretion. AccessGUDID - DEVICE: Epic Vascular (08714729805014) THE List - MRI Safety If a device is not shown in the list, it is not MR Conditional. Sterile. H7YPnf'Sq-. {}(;]xjx$,&\I'esU7;O*G@MI9YO?V6t N=9nq}^I pk2f5RVw>bd.Ms@G7'^,UPX_4~KO$rS8ILEn5WVu >V:RD/L u 9cwM\^$h IOK #>of=eP V}-St:Ur{>J;{n=b^mZ? The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. 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 Boston Scientific, www.bostonscientific.com . 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. 2*Uax?t}
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