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AccessGUDID - DEVICE: Epic Vascular (08714729805014) The results found that the stent was MRI .
AccessGUDID - DEVICE: Ascerta Firm (08714729861775) Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.
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The FDA has identified this as a Class I recall, the most serious type of recall. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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 Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. There have been 17 complaints and reported injuries related to this issue. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 2022 Boston Scientific Corporation or its affiliates. Drummond wire (316L SS) orthopedic implant. Coils, Filters, Stents, and Grafts More. Dont scan the patient if any adverse conditions are present. 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. @Bd!$7@"rAOgx
GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Read our privacy policy to learn more. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. 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. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ .
Metal Expandable Biliary Stents - Food and Drug Administration Epic Stent Boston Scientific, www.bostonscientific.com. The product, pouch label and carton label are all correct and the correct DFU is in the package. The stent is constrained within a 6F delivery system.
MRI Safety Home This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Use this database for coronary intervention, peripheral intervention and valve repair products. 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 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). 0.3. Please be sure to read it.
PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Newmatic Medical, www.newmaticmedical.com.
Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). The Sentinol Nitinol Stent System is comprised of two components: the implantable . 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. Fortunately, the devices that exhibited po . The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system.
News Releases - Boston Scientific 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. IFbj.)D^7TE.V\Bz->/. 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
Epic Vascular Self-Expanding Stent System - Boston Scientific Indicates a trademark of the Abbott group of companies. f@ 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. This site is Exclusively Sponsored by BRACCO.
THE List - MRI Safety It is required to program the device to MRI Settings as part of the MRI scan workflow. [N-'u,uDQOUyUInFl
yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. 2023 Boston Scientific Corporation or its affiliates.
PDF Summary of Safety and Effectiveness Data (Ssed) Cautionary Statement Regarding Forward-Looking Statements. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Boston Scientific 2 Agenda I. [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.
THE List - MRI Safety If needed, perform capture and sense and lead impedance tests. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. 38948-8607. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Use of these devices may cause serious injuries or death.
PDF Summary of Safety and Effectivness (SSED)Template Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. endstream
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Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent.
Catalog No. 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. Precautions
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. 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. endstream
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Refer to the . 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.
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI Search for coronary and peripheral disease and valve disease IFUS. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Overview of the ELUVIA Drug- Eluting Stent (DES) III. 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. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. You can search by product, model number, category or family. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Sterile. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. HWnFC=ji6n
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9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? The site is secure. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Dry Pad 9 x 9 with Silver Antimicrobial Agent. 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. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. H7YPnf'Sq-. For more information, please visit: www.bostonscientific.com. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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/. The Epic Stent should not migrate in this MRI environment. MR imaging provides excellent spatial . Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Magnetic Resonance MR Conditional 3.0 tesla temperature information 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. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. 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: DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t
The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). 121 0 obj
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This press release contains forward-looking statements. 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. About Epic and the ORION Trial The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. }7MWJ!%c. All rights reserved. Search for arrhythmia, heart failure and structural heart IFUs.
Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. "The Epic Stent has been very well-received by physicians across the country. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. 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.