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 prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. 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 [?] 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 Sentinol Nitinol Stent System is comprised of two components: the implantable . PDF Table of Contents - WATCHMAN Class 3 Device Recall Sentinol Nitinol Biliary Stent System. It is required to program the device to MRI Settings as part of the MRI scan workflow. 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. There have been 17 complaints and reported injuries related to this issue. 0 All rights reserved. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729959915 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent With Side Holes 6Fx28CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers 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. 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 [?] If a device is not shown in the list, it is not MR Conditional. 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. }7MWJ!%c. An official website of the United States government, : 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. endstream endobj startxref Magnetic Resonance MR Conditional 3.0 tesla temperature information These devices are considered MR Unsafe. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. PDF Summary of Safety and Effectiveness Boston Scientific 2 Agenda I. Conditional 6 More. 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 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. 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. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook hbbd``b` C9E tk`/@PHA,HyM! PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep 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. 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. 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. PDF 2 7 2 Epic Vascular 2 - Boston Scientific Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. The Epic Stent should not migrate in this MRI environment. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. 3: Conditional 6 . Reproduced with Permission from the GMDN Agency. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. It was launched in the United States in May of 2012. 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. Safety of Magnetic Resonance Imaging in Patients With - Circulation The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE 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. Coronary data supports safety of paclitaxel and ELUVIA DES IV. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. 121 0 obj <>stream The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. If needed, perform capture and sense and lead impedance tests. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. 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. Applicant's Name and Address: Boston Scientific Scimed Inc. One Scimed Place Maple Grove MN 55311-1566 PMA Number: P980033 Date of Notice of Approval to the Applicant: Novermber 16, 2001 2. All other trademarks are the property of their respective owners. Introduction II. 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. 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. Safe More. 1.5,3: "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. Coils, Filters, Stents, and Grafts More. 1) Confirm MRI readiness. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). %PDF-1.4 % 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. 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). Please be sure to read it. 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. Find products, medical specialty information, and education opportunities. 0.3. Follow the checklist instructions within Merlin PCS Programmer. 38948-8607. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. 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. "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.". THE List - MRI Safety No deaths have been reported. 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. THE List - MRI Safety This site is Exclusively Sponsored by BRACCO. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 2*Uax?t} Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. No amputations were reported through the 12-month period. Indicates a trademark of the Abbott group of companies. BSC began marketing the product internationally following approval in September 2001. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. The MRI parameter settings are selected at the physician's discretion. 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. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. The FDA has identified this as a Class I recall, the most serious type of recall. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Instructions for Downloading Viewers and Players. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. {}(;]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? 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 Boston Scientific Epic Stent Continues to Demonstrate Positive 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. IFbj.)D^7TE.V\Bz->/. 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. 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 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. News Releases - Boston Scientific "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. AccessGUDID - DEVICE: Epic Vascular (08714729805014) Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Indicates a third party trademark, which is property of its respective owner. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. 1.5 . Search for coronary and peripheral disease and valve disease IFUS. MR imaging provides excellent spatial . A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Catalog No. 2023 Boston Scientific Corporation or its affiliates. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Use of these devices may cause serious injuries or death. CAUTION: These products are intended for use by or under the direction of a physician. Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Epic Vascular Self-Expanding Stent System - Boston Scientific %PDF-1.5 % Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Note: If you need help accessing information in different file formats, see By using this site, you consent to the placement of our cookies. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. 5-year data for. 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. %%EOF Disposable devices associated with implantation may be included. 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.

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