The revised Express2 bare-metal stent DFU will be available shortly. 1.5,3: Orthopedic Implants, Materials, and Devices More. BSC began marketing the product internationally following approval in September 2001. Note: If you need help accessing information in different file formats, see
If the stent migrates to the heart, it could cause life-threatening injury. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. 121 0 obj
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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. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 1.5 . For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook 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. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. 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 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/. Before sharing sensitive information, make sure you're on a federal government site. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. If needed, perform capture and sense and lead impedance tests. Are you a healthcare professional? "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. An inner shaft, with two radiopaque markers, aids in the placement of the stent. 38948-8607. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. All rights reserved. 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. 59 0 obj
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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. Catalog No. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. 2022 Boston Scientific Corporation or its affiliates. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. MR imaging provides excellent spatial . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Coronary data supports safety of paclitaxel and ELUVIA DES IV. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Enterra II Model 37800Gastric Electrical Stimulation (GES) SystemEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Enterra TherapyGastric Electrical Stimulation (GES) SystemModels 3116 and 7425 GEnterra II Model 37800Medtronic, Inc., www.medtronic.com, Entovis ProMRI Cardiac Pacing SystemWhich consists of the Entovis pulse generator and the Setrox S and Safio S leadsBIOTRONIK, Inc., http://www.biotronikusa.com/manuals/index.cfmNote that the MR Condi, ENTRI-FLEXEntriFlexNasogastric (NG) Feeding TubeCOVIDIENHazelwood, MO, ENTRISTARJejunum Feeding Tube/Gastric Depression TubeCOVIDIENHazelwood, MO, EOI Spinal System EPPS (Expanding Polyaxial Pedicle Screw)Expanding Orthopedics Inc.Israel, EOS (Endoluminal Occlusion System) ImplantMedical Murray, Inc., medicalmurray.com, Epic StentBoston Scientific, www.bostonscientific.com, EpicageAlphatec Spine Inc., www.alphatecspine.com, Episealer Knee CondyleEpisurf Medical AB, www.episurf.com, Equi-Flow Valve System(s)15174, SLRKL, SLSKLL, 15175, SLRKLL,SLSKLM, 15179, SLRKLM, SLSKM, 15185,SLRKM, SLSL, 15549, SLRL, SLSLL,15551, SLRLL, SLSLM, 15552, SLRLM,SLSM, 15554, SLRM, 15181, 15555,SLSKL, Equine Pericardial Patch, Model XAGEdwards Lifesciences, www.edwards.com, EquipLite bladeTruphatek International LTD., www.truphatek.com, ES-830 MicroCutter Green StapleCardica, Inc. and Dextera Surgical, www.dexterasurgical.com, EsophaCoil-SRnitinolcoil, stent, filterIntratherapeutics, Inc.St. No deaths have been reported. Fortunately, the devices that exhibited po . endstream
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You can search by model number or product category. An official website of the United States government, : Overview of the ELUVIA Drug- Eluting Stent (DES) III. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. These devices are considered MR Unsafe. Introduction II. Please be sure to read it. 2*Uax?t} 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. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Can I undergo MRI or scanner testing with a stent? Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. For more information, please visit: www.bostonscientific.com. There have been 17 complaints and reported injuries related to this issue. As the stent is exposed to body temperature it expands to appose the duct wall. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. May be removed prior to MRI and replaced after the MRI exam. This cautionary statement is applicable to all forward-looking statements contained in this document. Coils, Filters, Stents, and Grafts More. 86 0 obj
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Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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). 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. 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. }7MWJ!%c. 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. The stent is constrained within a 6F delivery system. 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. Use this database for arrhythmia, heart failure and structural heart products. 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. If a device is not shown in the list, it is not MR Conditional. 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. %%EOF
Alternatively, you can also use the latest MRI Manuals to determine scan parameters. The FDA has identified this as a Class I recall, the most serious type of recall. The Epic Stent should not migrate in this MRI environment. Marlborough, MA 01752-1566 . Boston Scientific, www.bostonscientific.com . Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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.