If needed, perform capture and sense and lead impedance tests. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. 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. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. All rights reserved. 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." 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 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 [?] For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. (0.89mm) guidewires. 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: 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 Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Use of these devices may cause serious injuries or death. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. "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.". Coronary data supports safety of paclitaxel and ELUVIA DES IV. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. For more information, please visit: www.bostonscientific.com. Cautionary Statement Regarding Forward-Looking Statements. 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. These devices are considered MR Unsafe. Orthopedic Implants, Materials, and Devices More. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Boston Scientific Corporation . 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. 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. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. The delivery system is compatible with 0.035 in. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. It was launched in the United States in May of 2012. Are you a healthcare professional? 38948-8607. 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. Conditional 6 More. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. @Bd!$7@"rAOgx 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. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. hbbd``b` C9E tk`/@PHA,HyM! Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. 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 FDA has identified this as a Class I recall, the most serious type of recall. 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. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. 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 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. The results found that the stent was MRI . Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 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. 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. 2*Uax?t} 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. It is required to program the device to MRI Settings as part of the MRI scan workflow. Several of these demonstrated magnetic field interactions. To look up your patients system, use the Product Search tool to determine whether your patients device and leads (if applicable) are safe for an MRI. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug MRI Safety Home Newmatic Medical, www.newmaticmedical.com. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The MRI parameter settings are selected at the physician's discretion. H7YPnf'Sq-. 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. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE (,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 The revised Express2 bare-metal stent DFU will be available shortly. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Epic Vascular Self-Expanding Stent System - Boston Scientific The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) 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. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. An inner shaft, with two radiopaque markers, aids in the placement of the stent. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. News Releases - Boston Scientific 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. THE List - MRI Safety GMDN Names and Definitions: Copyright GMDN Agency 2015. Use this database for coronary intervention, peripheral intervention and valve repair products. Safety of Magnetic Resonance Imaging in Patients With - Circulation The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Overview of the ELUVIA Drug- Eluting Stent (DES) III. Please be sure to read it. Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI }7MWJ!%c. The stent is constrained within a 6F delivery system. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. PDF Summary of Safety and Effectivness (SSED)Template Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. This site uses cookies. All rights reserved. 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. For more information, please visit: www.bostonscientific.com. %PDF-1.5 % :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 prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. "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. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. You can search by product, model number, category or family. of Abbott Medical Japan GK. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. This press release contains forward-looking statements. Coils, Filters, Stents, and Grafts More. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 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 Refer to the . Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . A stent delivery system for a balloon expandable stent consists Fortunately, the devices that exhibited po . AccessGUDID - DEVICE: Epic Vascular (08714729805014) The .gov means its official.Federal government websites often end in .gov or .mil. 38948-8607. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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. 3: Conditional 6 . The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. 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. 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. 1) Confirm MRI readiness. 300 Boston Scientific Way . 1.5,3: Conditional 5 More . 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. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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. Epic Stent Boston Scientific, www.bostonscientific.com. AccessGUDID - DEVICE: Ascerta (08714729802976) May be removed prior to MRI and replaced after the MRI exam. Follow the checklist instructions within Merlin PCS Programmer. 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. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. THE List - MRI Safety PDF Table of Contents - WATCHMAN Magnetic Resonance MR Conditional 3.0 tesla temperature information Class 3 Device Recall Sentinol Nitinol Biliary Stent System Drummond wire (316L SS) orthopedic implant. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . "The Epic Stent has been very well-received by physicians across the country. 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