boston scientific epic stent mri safety

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. [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, MRI Ready Systems Manual or MRI Ready Leadless System Manual, Interrogate the device with the Merlin PCS Programmer. 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. 38948-8607. The .gov means its official.Federal government websites often end in .gov or .mil. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. %%EOF Indicates a trademark of the Abbott group of companies. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Coils, Filters, Stents, and Grafts More. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . The Epic Stent should not migrate in this MRI environment. 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. 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. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. Coils, Filters, Stents, and Grafts More. Boston Scientific 2 Agenda I. By using this site, you consent to the placement of our cookies. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. 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.". PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . The Boston Scientific Epic Stent Continues to Demonstrate Positive AccessGUDID - DEVICE: Ascerta (08714729802976) The site is secure. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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). The Sentinol Nitinol Stent System is comprised of two components: the implantable . 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. 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 [?] "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. 38948-8607. Proper patient monitoring must be provided during the MRI scan. Magnetic Resonance MR Conditional 3.0 tesla temperature information 3: Conditional 6 . 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 Follow the checklist instructions within Merlin PCS Programmer. Use of these devices may cause serious injuries or death. Introduction II. Catalog No. If needed, perform capture and sense and lead impedance tests. 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).? %PDF-1.4 % The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. 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. The delivery system is compatible with 0.035 in. The FDA has identified this as a Class I recall, the most serious type of recall. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 2*Uax?t} 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. 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. 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. 0.3. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Safe More. Find products, medical specialty information, and education opportunities. Reproduced with Permission from the GMDN Agency. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent MRI Safety for Cardiovascular Products I Abbott Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. AccessGUDID - DEVICE: Tria Soft (08714729959915) All other trademarks are the property of their respective owners. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. {}(;]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? 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. AccessGUDID - DEVICE: Epic Vascular (08714729805014) 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. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug Cautionary Statement Regarding Forward-Looking Statements. 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. 2023 Boston Scientific Corporation or its affiliates. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? All rights reserved. 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. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. An inner shaft, with two radiopaque markers, aids in the placement of the stent. Class 3 Device Recall Sentinol Nitinol Biliary Stent System 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. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Several of these demonstrated magnetic field interactions. 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. IFbj.)D^7TE.V\Bz->/. 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. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Use this database for arrhythmia, heart failure and structural heart products. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . Safety of Magnetic Resonance Imaging in Patients With - Circulation 0 %PDF-1.5 % Orthopedic Implants, Materials, and Devices More. Find out who we are, explore careers at the company, and view our financial performance. 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). 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." The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. hbbd``b` C9E tk`/@PHA,HyM! Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Several of these demonstrated magnetic field interactions. MRI Safety Home H7YPnf'Sq-. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. You can search by model number or product category. }7MWJ!%c. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. May be removed prior to MRI and replaced after the MRI exam. MR imaging provides excellent spatial . Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. (0.89mm) guidewires. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Refer to the . ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. 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/. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. PDF 2 7 2 Epic Vascular 2 - Boston Scientific This site uses cookies. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. 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. 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 The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. THE List - MRI Safety THE List - MRI Safety 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 revised Express2 bare-metal stent DFU will be available shortly. Newmatic Medical, www.newmaticmedical.com. endstream endobj startxref 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. 59 0 obj <> endobj Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Disposable devices associated with implantation may be included. PDF Summary of Safety and Effectivness (SSED)Template "The positive 12-month data from the ORION trial complement our early launch success and market share gains," said Jeff Mirviss, president of Peripheral Interventions at Boston Scientific. No amputations were reported through the 12-month period. 2022 Boston Scientific Corporation or its affiliates. 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 1.5,3: Conditional 5 More . Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. No deaths have been reported. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). AccessGUDID - DEVICE: Ascerta Firm (08714729861775) Dont scan the patient if any adverse conditions are present. :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\. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. 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.

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