It is required to program the device to MRI Settings as part of the MRI scan workflow. Several of these demonstrated magnetic field interactions. 1.5,3: Conditional 5 More . 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. Marlborough, MA 01752-1566 . IFbj.)D^7TE.V\Bz->/. You can search by model number or product category. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. All other trademarks are the property of their respective owners. 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. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. 0.3. Read our privacy policy to learn more. Overview of the ELUVIA Drug- Eluting Stent (DES) III. :V
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The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. 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. Epic Stent Boston Scientific, www.bostonscientific.com. Precautions
Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. 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. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. 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. Find out who we are, explore careers at the company, and view our financial performance. %PDF-1.5
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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 CAUTION: These products are intended for use by or under the direction of a physician. No amputations were reported through the 12-month period. 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. [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. 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 ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. "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. As the stent is exposed to body temperature it expands to appose the duct wall. Use this database for arrhythmia, heart failure and structural heart products. PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug 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. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. All rights reserved. Class 3 Device Recall Sentinol Nitinol Biliary Stent System HWnFC=ji6n
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9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The delivery system is compatible with 0.035 in. 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. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. The results found that the stent was MRI . The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. 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 TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. 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? Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. 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. hbbd``b` C9E tk`/@PHA,HyM! Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Catalog No. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. If a device is not shown in the list, it is not MR Conditional. The Sentinol Nitinol Stent System is comprised of two components: the implantable . Please be sure to read it. 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. PDF Summary of Safety and Effectiveness Data (Ssed) Search for coronary and peripheral disease and valve disease IFUS. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. If needed, perform capture and sense and lead impedance tests. This press release contains forward-looking statements. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. 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. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. It was launched in the United States in May of 2012. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. 59 0 obj
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For more information, please visit: www.bostonscientific.com. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Fortunately, the devices that exhibited po . Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan.