boston scientific epic stent mri safety

Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 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 PDF Summary of Safety and Effectiveness Data (Ssed) 0 Coils, Filters, Stents, and Grafts More. THE List - MRI Safety 2022 Boston Scientific Corporation or its affiliates. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. BSC began marketing the product internationally following approval in September 2001. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Indicates a third party trademark, which is property of its respective owner. Are you a healthcare professional? Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Catalog No. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Proper patient monitoring must be provided during the MRI scan. 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 check the MRI scan parameter tables for the applicable scan and identify the settings for RF Transmit Conditions and scan regions. The delivery system is compatible with 0.035 in. of Abbott Medical Japan GK. 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). 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. MR imaging provides excellent spatial . Introduction II. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. For more information, please visit: www.bostonscientific.com. f@ News Releases - Boston Scientific The Sentinol Nitinol Stent System is comprised of two components: the implantable . 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. Follow the checklist instructions within Merlin PCS Programmer. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. An inner shaft, with two radiopaque markers, aids in the placement of the stent. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t GMDN Names and Definitions: Copyright GMDN Agency 2015. 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 - Ascerta Firm (08714729861720)- Ureteral Stent. Several of these demonstrated magnetic field interactions. 1.5,3: 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. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 2023 Boston Scientific Corporation or its affiliates. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. 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. {}(;]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? All rights reserved. Newmatic Medical, www.newmaticmedical.com. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 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. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel 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. The FDA has identified this as a Class I recall, the most serious type of recall. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. Boston Scientific, www.bostonscientific.com . Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 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. Read our privacy policy to learn more. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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. Boston Scientific 2 Agenda I. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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 information provided here is not intended to provide information to patients and the general public. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Cautionary Statement Regarding 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. CAUTION: These products are intended for use by or under the direction of a physician. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 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. Several of these demonstrated magnetic field interactions. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) If a device is not shown in the list, it is not MR Conditional. Orthopedic Implants, Materials, and Devices More. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . Metal Expandable Biliary Stents - Food and Drug Administration %PDF-1.4 % Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . For more information, please visit: www.bostonscientific.com. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All rights reserved. The site is secure. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. [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. This site uses cookies. 121 0 obj <>stream The MRI parameter settings are selected at the physician's discretion. These devices are considered MR Unsafe. 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.". Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Search for arrhythmia, heart failure and structural heart IFUs. This site is Exclusively Sponsored by BRACCO. Use of these devices may cause serious injuries or death. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. May be removed prior to MRI and replaced after the MRI exam. 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). Class 3 Device Recall Sentinol Nitinol Biliary Stent System 1) Confirm MRI readiness. Fortunately, the devices that exhibited po . 0.3. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. endstream endobj startxref THE List - MRI Safety AccessGUDID - DEVICE: Epic Vascular (08714729805014) Sterile. THE List - MRI Safety 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. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. There have been 17 complaints and reported injuries related to this issue. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. THE List - MRI Safety 38948-8607. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Catalog No. 1.5,3: Conditional 5 More . Safe More. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. PDF Table of Contents - WATCHMAN The .gov means its official.Federal government websites often end in .gov or .mil. 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. Magnetic Resonance MR Conditional 3.0 tesla temperature information 300 Boston Scientific Way . Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Safety of Magnetic Resonance Imaging in Patients With - Circulation 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. 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. 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. PDF Summary of Safety and Effectiveness Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. 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. PDF 2 7 2 Epic Vascular 2 - Boston Scientific Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Dry Pad 9 x 9 with Silver Antimicrobial Agent. 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. Epic Vascular Self-Expanding Stent System - Boston Scientific 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug 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. 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." 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: 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. 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. "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. 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. Premarket Approval (PMA) Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 hbbd``b` C9E tk`/@PHA,HyM! Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Reproduced with Permission from the GMDN Agency. It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across a variety of stent sizes. All other trademarks are the property of their respective owners. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Disposable devices associated with implantation may be included. Search for coronary and peripheral disease and valve disease IFUS. 3: Conditional 6 . The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). 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. 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 This press release contains forward-looking statements. 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