boston scientific epic stent mri safety

"Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 5-year data for. 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. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. This includes continuous monitoring of the patient's hemodynamic function. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 hbbd``b` C9E tk`/@PHA,HyM! PDF Summary of Safety and Effectiveness Data (Ssed) Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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 Are you a healthcare professional? Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . AccessGUDID - DEVICE: Tria Soft (08714729959915) Newmatic Medical, www.newmaticmedical.com. 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. 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. Safety of Magnetic Resonance Imaging in Patients With - Circulation The information provided here is not intended to provide information to patients and the general public. 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. 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. 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. The stent is constrained within a 6F delivery system. The FDA has identified this as a Class I recall, the most serious type of recall. Follow the checklist instructions within Merlin PCS Programmer. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. PDF Summary of Safety and Effectiveness Several of these demonstrated magnetic field interactions. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. 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. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Marlborough, MA 01752-1566 . The results found that the stent was MRI . 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. Before sharing sensitive information, make sure you're on a federal government site. "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. You can search by model number or product category. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. This site uses cookies. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 2022 Boston Scientific Corporation or its affiliates. %PDF-1.5 % With our stent systems, MRI analyses can now be performed immediately.". 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 List - MRI Safety GMDN Names and Definitions: Copyright GMDN Agency 2015. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. A stent delivery system for a balloon expandable stent consists 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 H7YPnf'Sq-. 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. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug 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). 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. 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. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Several of these demonstrated magnetic field interactions. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Search for arrhythmia, heart failure and structural heart IFUs. The TAXUS Express2 and Express2 systems were shown to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t THE List - MRI Safety Reproduced with Permission from the GMDN Agency. All rights reserved. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent The MRI parameter settings are selected at the physician's discretion. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Overview of the ELUVIA Drug- Eluting Stent (DES) III. 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. 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." Find products, medical specialty information, and education opportunities. Use of these devices may cause serious injuries or death. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel 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. 2023 Boston Scientific Corporation or its affiliates. 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. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Instructions for Downloading Viewers and Players. Refer to the . 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.". These devices are considered MR Unsafe. 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. 3: Conditional 6 . of Abbott Medical Japan GK. An inner shaft, with two radiopaque markers, aids in the placement of the stent. 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. It is required to program the device to MRI Settings as part of the MRI scan workflow. Orthopedic Implants, Materials, and Devices More. 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. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. The Boston Scientific Epic Stent Continues to Demonstrate Positive Find out who we are, explore careers at the company, and view our financial performance. 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: AccessGUDID - DEVICE: Epic Vascular (08714729805014) The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Note: If you need help accessing information in different file formats, see Catalog No. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. You can search by product, model number, category or family. Use this database for coronary intervention, peripheral intervention and valve repair products. endstream endobj startxref Precautions Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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, 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. No amputations were reported through the 12-month period. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. 300 Boston Scientific Way . Use this database for arrhythmia, heart failure and structural heart products. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) For more information, please visit: www.bostonscientific.com. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Introduction II. 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 [?] (0.89mm) guidewires. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. The product, pouch label and carton label are all correct and the correct DFU is in the package. All rights reserved. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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 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. 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. 2*Uax?t} 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. "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 Express 2 (bare-metal) stent system also received approval for immediate MRI exams. Conditional 6 More. 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 $Xp7lXcV5ZID?vM1V]kM).? Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. Drummond wire (316L SS) orthopedic implant. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. Boston Scientific Corporation . Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. PDF Summary of Safety and Effectivness (SSED)Template To look up your patient's system, use the Product Search tool to determine whether your patient's device and leads (if applicable) are safe for an MRI. Dry Pad 9 x 9 with Silver Antimicrobial Agent. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. It was launched in the United States in May of 2012. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. This site is Exclusively Sponsored by BRACCO. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. THE List - MRI Safety {}(;]xjx$,&\I'esU7;O*G@MI9YO?V6t N=9nq}^I pk2f5RVw>bd.Ms@G7'^,UPX_4~KO$rS8ILEn5WVu >V:RD/L u 9cwM\^$h IOK #>of=eP V}-St:Ur{>J;{n=b^mZ? Cautionary Statement Regarding Forward-Looking Statements. Please be sure to read it. 121 0 obj <>stream endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . 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/. MRI Safety Home MR imaging provides excellent spatial . Disposable devices associated with implantation may be included. If needed, perform capture and sense and lead impedance tests. 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. 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. 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. 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.

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