All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. hbbd``b` C9E tk`/@PHA,HyM! 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. 3: Conditional 6 . 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).? Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. 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. Orthopedic Implants, Materials, and Devices More. 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. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 59 0 obj <> endobj "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. Note: If you need help accessing information in different file formats, see The product, pouch label and carton label are all correct and the correct DFU is in the package. :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\. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) 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. Epic Stent Boston Scientific, www.bostonscientific.com. 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. If needed, perform capture and sense and lead impedance tests. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The delivery system is compatible with 0.035 in. 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. With our stent systems, MRI analyses can now be performed immediately.". The Boston Scientific Epic Stent Continues to Demonstrate Positive 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. PDF Summary of Safety and Effectiveness Data (Ssed) %%EOF Catalog No. Precautions 300 Boston Scientific Way . 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. 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. Disposable devices associated with implantation may be included. This includes continuous monitoring of the patient's hemodynamic function. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. This site is Exclusively Sponsored by BRACCO. Can I undergo MRI or scanner testing with a stent? Magnetic Resonance MR Conditional 3.0 tesla temperature information Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. 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. THE List - MRI Safety Conditional 6 More. 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. 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. 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 [?] of Abbott Medical Japan GK. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. This press release contains forward-looking statements. May be removed prior to MRI and replaced after the MRI exam. Introduction II. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. This cautionary statement is applicable to all forward-looking statements contained in this document. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Dry Pad 9 x 9 with Silver Antimicrobial Agent. Boston Scientific 2 Agenda I. Indicates a trademark of the Abbott group of companies. 38948-8607. BSC began marketing the product internationally following approval in September 2001. 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. AccessGUDID - DEVICE: Ascerta (08714729802976) These devices are considered MR Unsafe. The MRI parameter settings are selected at the physician's discretion. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. You can search by model number or product category. Boston Scientific, www.bostonscientific.com . Use this database for arrhythmia, heart failure and structural heart products. If the stent migrates to the heart, it could cause life-threatening injury. If a device is not shown in the list, it is not MR Conditional. "The Epic Stent has been very well-received by physicians across the country. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . 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.". IFbj.)D^7TE.V\Bz->/. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Marlborough, MA 01752-1566 . CAUTION: These products are intended for use by or under the direction of a physician. 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). The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . You can search by product, model number, category or family. No amputations were reported through the 12-month period. Fortunately, the devices that exhibited po . Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Read our privacy policy to learn more. H7YPnf'Sq-. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . 2022 Boston Scientific Corporation or its affiliates. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0.3. Drummond wire (316L SS) orthopedic implant. 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. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 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. 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. %PDF-1.4 % 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The stent is constrained within a 6F delivery system. 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. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook Proper patient monitoring must be provided during the MRI scan. Sterile. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Coils, Filters, Stents, and Grafts More. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. PDF Summary of Safety and Effectivness (SSED)Template 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 TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes No deaths have been reported. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Find out who we are, explore careers at the company, and view our financial performance. 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. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. The Sentinol Nitinol Stent System is comprised of two components: the implantable . Indicates a third party trademark, which is property of its respective owner. 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. 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. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t THE List - MRI Safety Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 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 PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep PDF Table of Contents - WATCHMAN 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. 5-year data for. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. 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. THE List - MRI Safety 1.5,3: The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. 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.
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