"Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . Please be sure to read it. 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. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. Instructions for Downloading Viewers and Players. 2022 Boston Scientific Corporation or its affiliates. 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. [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. Proper patient monitoring must be provided during the MRI scan. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. The stent is constrained within a 6F delivery system. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Use this database for arrhythmia, heart failure and structural heart products. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. No amputations were reported through the 12-month period. 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. IFbj.)D^7TE.V\Bz->/. BSC began marketing the product internationally following approval in September 2001. 2023 Boston Scientific Corporation or its affiliates. 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. 3: Conditional 6 . Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. 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 All rights reserved. THE List - MRI Safety 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. 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. Sterile. PDF Summary of Safety and Effectiveness Data (Ssed) Reproduced with Permission from the GMDN Agency. 1.5 . %%EOF 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. 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 $Xp7lXcV5ZID?vM1V]kM).? Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. Before sharing sensitive information, make sure you're on a federal government site. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Premarket Approval (PMA) Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Safe More. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Boston Scientific Corporation . Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Magnetic Resonance MR Conditional 3.0 tesla temperature information You can search by model number or product category. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. {}(;]xjx$,&\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? Note: If you need help accessing information in different file formats, see May be removed prior to MRI and replaced after the MRI exam. Follow the checklist instructions within Merlin PCS Programmer. This press release contains forward-looking statements. These devices are considered MR Unsafe. AccessGUDID - DEVICE: Tria Soft (08714729959915) Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. 300 Boston Scientific Way . "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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. A Boston Scientific Study of the Epic Self-Expanding Nitonol Stent System in the treatment of Atherosclerotic Lesions in Iliac Arteries 0 amputations at 3 years (106 subjects) 89.9% Freedom from TLR at 3 years (143 lesions) ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications It was launched in the United States in May of 2012. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. 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. 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. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes The product, pouch label and carton label are all correct and the correct DFU is in the package. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. 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. CAUTION: These products are intended for use by or under the direction of a physician. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Conditional 6 More. PDF 2 7 2 Epic Vascular 2 - Boston Scientific The .gov means its official.Federal government websites often end in .gov or .mil. Newmatic Medical, www.newmaticmedical.com. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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 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. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). 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. AccessGUDID - DEVICE: Epic Vascular (08714729805014) Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. PDF Summary of Safety and Effectivness (SSED)Template "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Use of these devices may cause serious injuries or death. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 No deaths have been reported. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 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. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Use this database for coronary intervention, peripheral intervention and valve repair products. "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. 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). Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. 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. Orthopedic Implants, Materials, and Devices More. MRI Safety for Cardiovascular Products I Abbott }7MWJ!%c. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Indicates a trademark of the Abbott group of companies. 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. An inner shaft, with two radiopaque markers, aids in the placement of the stent. 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 [?]
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