boston scientific epic stent mri safety

MRI safety testing has shown that the REBEL Stent is MR Conditional and that PDF Table of Contents - WATCHMAN If the stent migrates to the heart, it could cause life-threatening injury. PDF Summary of Safety and Effectiveness Data (Ssed) 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. 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. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. The information provided here is not intended to provide information to patients and the general public. Refer to the . Search for arrhythmia, heart failure and structural heart IFUs. 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. Boston Scientific 2 Agenda I. }7MWJ!%c. There have been 17 complaints and reported injuries related to this issue. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Use of these devices may cause serious injuries or death. The product, pouch label and carton label are all correct and the correct DFU is in the package. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Premarket Approval (PMA) Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. of Abbott Medical Japan GK. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 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. This site is Exclusively Sponsored by BRACCO. You can search by product, model number, category or family. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. 38948-8607. f@ Catalog No. The Epic Stent should not migrate in this MRI environment. 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/. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Proper patient monitoring must be provided during the MRI scan. 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. 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. 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. Instructions for Downloading Viewers and Players. 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. The delivery system is compatible with 0.035 in. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. Metal Expandable Biliary Stents - Food and Drug Administration GMDN Names and Definitions: Copyright GMDN Agency 2015. IFbj.)D^7TE.V\Bz->/. 3: Conditional 6 . Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 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. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) The revised Express2 bare-metal stent DFU will be available shortly. Indicates a third party trademark, which is property of its respective owner. The Sentinol Nitinol Stent System is comprised of two components: the implantable . Magnetic Resonance MR Conditional 3.0 tesla temperature information Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Before sharing sensitive information, make sure you're on a federal government site. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. Find out who we are, explore careers at the company, and view our financial performance. 1.5,3: Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. These devices are considered MR Unsafe. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 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. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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. The Boston Scientific Epic Stent Continues to Demonstrate Positive 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. MRI Safety for Cardiovascular Products I Abbott May be removed prior to MRI and replaced after the MRI exam. An inner shaft, with two radiopaque markers, aids in the placement of the stent. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Epic Stent Boston Scientific, www.bostonscientific.com. If a device is not shown in the list, it is not MR Conditional. For more information, please visit: www.bostonscientific.com. As the stent is exposed to body temperature it expands to appose the duct wall. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Indicates a trademark of the Abbott group of companies. All rights reserved. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. 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. AccessGUDID - DEVICE: Epic Vascular (08714729805014) Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. 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 Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 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. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Drummond wire (316L SS) orthopedic implant. 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. For more information, please visit: www.bostonscientific.com. 59 0 obj <> endobj Fortunately, the devices that exhibited po . News Releases - Boston Scientific AccessGUDID - DEVICE: Ascerta Firm (08714729861720) This press release contains forward-looking statements. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. 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. Orthopedic Implants, Materials, and Devices More. 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. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. 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. Sterile. Epic Vascular Self-Expanding Stent System - Boston Scientific By using this site, you consent to the placement of our cookies. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Safety of Magnetic Resonance Imaging in Patients With - Circulation Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. Boston Scientific, www.bostonscientific.com . 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. Enterra II Model 37800Gastric Electrical Stimulation (GES) SystemEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Enterra TherapyGastric Electrical Stimulation (GES) SystemModels 3116 and 7425 GEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Entovis ProMRI Cardiac Pacing SystemWhich consists of the Entovis pulse generator and the Setrox S and Safio S leadsBIOTRONIK, Inc., http://www.biotronikusa.com/manuals/index.cfmNote that the MR Condi, ENTRI-FLEXEntriFlexNasogastric (NG) Feeding TubeCOVIDIENHazelwood, MO, ENTRISTARJejunum Feeding Tube/Gastric Depression TubeCOVIDIENHazelwood, MO, EOI Spinal System EPPS (Expanding Polyaxial Pedicle Screw)Expanding Orthopedics Inc.Israel, EOS (Endoluminal Occlusion System) ImplantMedical Murray, Inc., medicalmurray.com, Epic StentBoston Scientific, www.bostonscientific.com, EpicageAlphatec Spine Inc., www.alphatecspine.com, Episealer Knee CondyleEpisurf Medical AB, www.episurf.com, Equi-Flow Valve System(s)15174, SLRKL, SLSKLL, 15175, SLRKLL,SLSKLM, 15179, SLRKLM, SLSKM, 15185,SLRKM, SLSL, 15549, SLRL, SLSLL,15551, SLRLL, SLSLM, 15552, SLRLM,SLSM, 15554, SLRM, 15181, 15555,SLSKL, Equine Pericardial Patch, Model XAGEdwards Lifesciences, www.edwards.com, EquipLite bladeTruphatek International LTD., www.truphatek.com, ES-830 MicroCutter Green StapleCardica, Inc. and Dextera Surgical, www.dexterasurgical.com, EsophaCoil-SRnitinolcoil, stent, filterIntratherapeutics, Inc.St. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The MRI parameter settings are selected at the physician's discretion. No deaths have been reported. Dry Pad 9 x 9 with Silver Antimicrobial Agent. AccessGUDID - DEVICE: Tria Soft (08714729959915) Dont scan the patient if any adverse conditions are present. Coils, Filters, Stents, and Grafts More. 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. 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. Conditional 6 More. Precautions 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. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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). Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 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 [?] Marlborough, MA 01752-1566 . 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. 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. THE List - MRI Safety "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. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. This cautionary statement is applicable to all forward-looking statements contained in this document. THE List - MRI Safety Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. 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. "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.". Newmatic Medical, www.newmaticmedical.com. Please be sure to read it. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. %PDF-1.4 % Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 2022 Boston Scientific Corporation or its affiliates. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Use this database for arrhythmia, heart failure and structural heart products. 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. 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. PDF 2 7 2 Epic Vascular 2 - Boston Scientific :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\. MRI Safety Home The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. 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. Disposable devices associated with implantation may be included. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Boston Scientific Corporation . 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 Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel H7YPnf'Sq-. Several of these demonstrated magnetic field interactions. 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. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . 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