Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. 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. (0.89mm) guidewires. The revised Express2 bare-metal stent DFU will be available shortly. 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).? GMDN Names and Definitions: Copyright GMDN Agency 2015. AccessGUDID - DEVICE: Ascerta (08714729802976) Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. 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. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. These devices are considered MR Unsafe. Class 3 Device Recall Sentinol Nitinol Biliary Stent System Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples. News Releases - Boston Scientific "The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. 300 Boston Scientific Way . 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. H7YPnf'Sq-. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . 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. Proper patient monitoring must be provided during the MRI scan. An official website of the United States government, : 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. The Epic Stent should not migrate in this MRI environment. hbbd``b` C9E tk`/@PHA,HyM! All rights reserved. Boston Scientific 2 Agenda I. For more information, please visit: www.bostonscientific.com. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 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 delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 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. 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. 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. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Use of these devices may cause serious injuries or death. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. As the stent is exposed to body temperature it expands to appose the duct wall. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 59 0 obj <> endobj The site is secure. 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. Can I undergo MRI or scanner testing with a stent? The FDA has identified this as a Class I recall, the most serious type of recall. Major adverse events are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. For more information, please visit: www.bostonscientific.com. 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 The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Follow the checklist instructions within Merlin PCS Programmer. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Catalog No. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Note: If you need help accessing information in different file formats, see %PDF-1.4 % Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 5-year data for. Read our privacy policy to learn more. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. 1.5,3: Conditional 5 More . It was launched in the United States in May of 2012. The Boston Scientific Epic Stent Continues to Demonstrate Positive Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. MR imaging provides excellent spatial . Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Cautionary Statement Regarding Forward-Looking Statements. CAUTION: These products are intended for use by or under the direction of a physician. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. You can search by model number or product category. The results found that the stent was MRI . Please be sure to read it. By using this site, you consent to the placement of our cookies. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Coils, Filters, Stents, and Grafts More. Overview of the ELUVIA Drug- Eluting Stent (DES) III. f@ Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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 [?] 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 how data will be handled by each system. Search for arrhythmia, heart failure and structural heart IFUs. BSC began marketing the product internationally following approval in September 2001. 3: Conditional 6 . Several of these demonstrated magnetic field interactions. 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). 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. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or 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.". Fortunately, the devices that exhibited po . Dont scan the patient if any adverse conditions are present. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes Marlborough, MA 01752-1566 . endstream endobj startxref As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. PDF Summary of Safety and Effectiveness Data (Ssed) 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. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Use this database for coronary intervention, peripheral intervention and valve repair products. With our stent systems, MRI analyses can now be performed immediately.". PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. AccessGUDID - DEVICE: Epic Vascular (08714729805014) The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. Before sharing sensitive information, make sure you're on a federal government site. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . 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. Refer to the . It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). If needed, perform capture and sense and lead impedance tests. May be removed prior to MRI and replaced after the MRI exam. Epic Vascular Self-Expanding Stent System - Boston Scientific Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The .gov means its official.Federal government websites often end in .gov or .mil. 121 0 obj <>stream Several of these demonstrated magnetic field interactions. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook Dry Pad 9 x 9 with Silver Antimicrobial Agent. PDF Summary of Safety and Effectivness (SSED)Template The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. 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. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 2*Uax?t} 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. It is required to program the device to MRI Settings as part of the MRI scan workflow. Metal Expandable Biliary Stents - Food and Drug Administration Magnetic Resonance MR Conditional 3.0 tesla temperature information The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). 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. Use this database for arrhythmia, heart failure and structural heart products. Safety of Magnetic Resonance Imaging in Patients With - Circulation :V m_C.4c9M/:4"Pp^8r_h_(2KDz]H4{T["y&7xPWe8Iw]rp%c2D|t-++@n 6j.#C\Ks _R]O%[D8Y}[1HshY$7\. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. This press release contains forward-looking statements. Sterile. 2022 Boston Scientific Corporation or its affiliates. Newmatic Medical, www.newmaticmedical.com. All rights reserved. 0 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. Reproduced with Permission from the GMDN Agency. 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 This includes continuous monitoring of the patient's hemodynamic function. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. There have been 17 complaints and reported injuries related to this issue. THE List - MRI Safety 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." 38948-8607. The Sentinol Nitinol Stent System is comprised of two components: the implantable . This site uses cookies. 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. Find out who we are, explore careers at the company, and view our financial performance. All rights reserved. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. THE List - MRI Safety CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). 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. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. 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. "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. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. A stent delivery system for a balloon expandable stent consists 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. 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. 2022 Boston Scientific Corporation or its affiliates. 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. THE List - MRI Safety Coils, Filters, Stents, and Grafts More. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 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 TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and outcomes, our technology, product performance and importance, and competitive offerings. 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. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. 1.5,3: The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. Boston Scientific, www.bostonscientific.com . MRI Safety for Cardiovascular Products I Abbott Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. @Bd!$7@"rAOgx All other trademarks are the property of their respective owners. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$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 To look up your patients system, use the Product Search tool to determine whether your patients device and leads (if applicable) are safe for an MRI. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. 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.
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