0.3. Find products, medical specialty information, and education opportunities. Use of these devices may cause serious injuries or death. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Coils, Filters, Stents, and Grafts More. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861775 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 [?]
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. No amputations were reported through the 12-month period. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. H7YPnf'Sq-. If the stent migrates to the heart, it could cause life-threatening injury. 1 0 obj
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The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Indicates a trademark of the Abbott group of companies. 1.5,3: Conditional 6 More. 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. 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. Catalog No. Proper patient monitoring must be provided during the MRI scan. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. MR imaging provides excellent spatial . Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. 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.". f@ Use this database for arrhythmia, heart failure and structural heart products. "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. 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. 0
1.5,3: Conditional 5 More . Disposable devices associated with implantation may be included. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. 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. 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 stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 Refer to the . :V
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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. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 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 2*Uax?t} GMDN Names and Definitions: Copyright GMDN Agency 2015. Magnetic Resonance MR Conditional 3.0 tesla temperature information Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. CAUTION: These products are intended for use by or under the direction of a physician. Are you a healthcare professional? Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Indicates a third party trademark, which is property of its respective owner. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 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. 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. Epic Stent Boston Scientific, www.bostonscientific.com. Several of these demonstrated magnetic field interactions. Find out who we are, explore careers at the company, and view our financial performance. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. You can search by model number or product category. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. Catalog No. The FDA has identified this as a Class I recall, the most serious type of recall. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. 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. These devices are considered MR Unsafe. 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. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. [N-'u,uDQOUyUInFl
yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Cautionary Statement Regarding Forward-Looking Statements. 2023 Boston Scientific Corporation or its affiliates. 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). Fortunately, the devices that exhibited po . Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. 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. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Boston Scientific, www.bostonscientific.com . 1) Confirm MRI readiness. 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. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. By using this site, you consent to the placement of our cookies. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. 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 check the MRI scan parameter tables for the applicable scan and identify the settings for RF Transmit Conditions and scan regions. All rights reserved. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. 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. hbbd``b` C9E tk`/@PHA,HyM!
Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. There have been 17 complaints and reported injuries related to this issue. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 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. 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. Immediately following the MRI procedure, follow the instructions in the MRI Ready Systems Manual or MRI Ready Leadless System Manual to revert to the permanently programmed settings. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 This press release contains forward-looking statements. HWnFC=ji6n
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9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? The MRI parameter settings are selected at the physician's discretion. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Coronary data supports safety of paclitaxel and ELUVIA DES IV. %PDF-1.5
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The stent is constrained within a 6F delivery system. 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. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. With our stent systems, MRI analyses can now be performed immediately.". Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This includes continuous monitoring of the patient's hemodynamic function. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. The C-code used for this product is C1876, Stent, non-coated/non-covered with 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. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. 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 Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. "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.". Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . Introduction II. These devices are considered MR Unsafe. 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." Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE