boston scientific epic stent mri safety

1.5,3: Before sharing sensitive information, make sure you're on a federal government site. 1.5,3: Conditional 5 More . Drummond wire (316L SS) orthopedic implant. The results found that the stent was MRI . Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 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 It is required to program the device to MRI Settings as part of the MRI scan workflow. 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. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. MRI safety testing has shown that the REBEL Stent is MR Conditional and that All rights reserved. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Refer to the . These devices are considered MR Unsafe. 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. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. 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. 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 revised Express2 bare-metal stent DFU will be available shortly. "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. 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. Use this database for coronary intervention, peripheral intervention and valve repair products. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Proper patient monitoring must be provided during the MRI scan. Find products, medical specialty information, and education opportunities. Precautions The Epic Stent should not migrate in this MRI environment. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Dont scan the patient if any adverse conditions are present. You can search by model number or product category. 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 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 TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Overview of the ELUVIA Drug- Eluting Stent (DES) III. 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 [?] Magnetic Resonance MR Conditional 3.0 tesla temperature information 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. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. The information provided here is not intended to provide information to patients and the general public. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Please be sure to read it. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. %PDF-1.4 % Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 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. Several of these demonstrated magnetic field interactions. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. "The Epic Stent has been very well-received by physicians across the country. 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 [?] Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . 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. 2023 Boston Scientific Corporation or its affiliates. This site is Exclusively Sponsored by BRACCO. 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. By using this site, you consent to the placement of our cookies. Coils, Filters, Stents, and Grafts More. 3: Conditional 6 . 38948-8607. Follow the checklist instructions within Merlin PCS Programmer. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. 121 0 obj <>stream 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. Conditional 6 More. A stent delivery system for a balloon expandable stent consists [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? 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. 300 Boston Scientific Way . 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. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. 1) Confirm MRI readiness. Are you a healthcare professional? The site is secure. 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. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. }7MWJ!%c. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. This includes continuous monitoring of the patient's hemodynamic function. MR imaging provides excellent spatial . Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. The stent is constrained within a 6F delivery system. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. You can search by product, model number, category or family. 2022 Boston Scientific Corporation or its affiliates. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. 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. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. 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. 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.

Aliquippa Football Players, Bridgestone Arena Covid Policy, What Type Of Colony Was Pennsylvania, National Harbor New Years Eve 2022 Fireworks, Michelle Urban Dictionary, Articles B