boston scientific epic stent mri safety3 on 3 basketball tournaments in colorado

Can I undergo MRI or scanner testing with a stent? Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. 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. Conditional 6 More. 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. 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. Marlborough, MA 01752-1566 . Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. 59 0 obj <> endobj 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. This site is Exclusively Sponsored by BRACCO. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. 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. 38948-8607. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. All rights reserved. A stent delivery system for a balloon expandable stent consists The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. The revised Express2 bare-metal stent DFU will be available shortly. 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). This press release contains forward-looking statements. %PDF-1.4 % The product, pouch label and carton label are all correct and the correct DFU is in the package. Coronary data supports safety of paclitaxel and ELUVIA DES IV. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The FDA has identified this as a Class I recall, the most serious type of recall. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 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. 1.5 . Find products, medical specialty information, and education opportunities. Are you a healthcare professional? A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. 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 see examples of checklist screens and get additional details about the checklist. 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. 2022 Boston Scientific Corporation or its affiliates. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. IFbj.)D^7TE.V\Bz->/. Note: If you need help accessing information in different file formats, see This includes continuous monitoring of the patient's hemodynamic function. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. An inner shaft, with two radiopaque markers, aids in the placement of the stent. 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. 5-year data for. Catalog No. The Epic Stent should not migrate in this MRI environment. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. The results found that the stent was MRI . Sterile. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. 0.3. 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). Overview of the ELUVIA Drug- Eluting Stent (DES) III. If needed, perform capture and sense and lead impedance tests. Several of these demonstrated magnetic field interactions. Refer to the . 121 0 obj <>stream VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See Medical Device Recall Database Entry Distribution Dates: September 21, 2018 to April 9, 2021 "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.". Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. No deaths have been reported. MRI safety testing has shown that the REBEL Stent is MR Conditional and that The delivery system is compatible with 0.035 in. 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. All other trademarks are the property of their respective owners. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. The MRI parameter settings are selected at the physician's discretion. 1.5,3: Cautionary Statement Regarding Forward-Looking Statements. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair.

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