This includes continuous monitoring of the patient's hemodynamic function. 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. 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. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Premarket Approval (PMA) of Abbott Medical Japan GK. 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). Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA.
Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Find products, medical specialty information, and education opportunities. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 2022 Boston Scientific Corporation or its affiliates. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 38948-8607. 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. As the stent is exposed to body temperature it expands to appose the duct wall. MR imaging provides excellent spatial . {}(;]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
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Conditional 6 More. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. 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. Overview of the ELUVIA Drug- Eluting Stent (DES) III. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 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. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. PDF Summary of Safety and Effectiveness Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. If the stent migrates to the heart, it could cause life-threatening injury. 121 0 obj
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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 [?] All other trademarks are the property of their respective owners. MRI safety testing has shown that the REBEL Stent is MR Conditional and that No deaths have been reported. 86 0 obj
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The revised Express2 bare-metal stent DFU will be available shortly. 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. Marlborough, MA 01752-1566 . You can search by model number or product category. 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.
This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. epic vascular self-expanding stent system: Boston Scientific Corp. P110035 S045: 04/03/2018: memorygel silicone gel-filled breast implants: MENTOR CORP. P030053 S045: 01/30/2018: reflection ceramic acetabular hip system: Smith & Nephew, Inc. P030022 S045: Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. The .gov means its official.Federal government websites often end in .gov or .mil. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. 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. 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. 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 Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. 5-year data for. CAUTION: These products are intended for use by or under the direction of a physician. H7YPnf'Sq-. All rights reserved. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. 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 default MRI parameter settings are automatically stored in the Abbott MR Conditional device. 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. An official website of the United States government, : 1.5,3: Conditional 5 More . AccessGUDID - DEVICE: Ascerta (08714729802976) C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to see examples of checklist screens and get additional details about the checklist. Coils, Filters, Stents, and Grafts More. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Several of these demonstrated magnetic field interactions. By using this site, you consent to the placement of our cookies. Boston Scientific, www.bostonscientific.com . Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 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. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. PDF 2 7 2 Epic Vascular 2 - Boston Scientific 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 hbbd``b` C9E tk`/@PHA,HyM! 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. Proper patient monitoring must be provided during the MRI scan. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. 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. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. You can search by product, model number, category or family. Can I undergo MRI or scanner testing with a stent? Indicates a trademark of the Abbott group of companies. Coronary data supports safety of paclitaxel and ELUVIA DES IV. 300 Boston Scientific Way . The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. A stent delivery system for a balloon expandable stent consists 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 ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Use of these devices may cause serious injuries or death. Fortunately, the devices that exhibited po . Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission. 0.3. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel 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. 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. 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 (0.89mm) guidewires. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. THE List - MRI Safety Catalog No. MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. 59 0 obj
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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. Epic Vascular Self-Expanding Stent System - Boston Scientific Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. With our stent systems, MRI analyses can now be performed immediately.". Note: If you need help accessing information in different file formats, see
Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Boston Scientific Corporation . An inner shaft, with two radiopaque markers, aids in the placement of the stent. 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. Metal Expandable Biliary Stents - Food and Drug Administration 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. For information, visit MagneticResonanceSafetyTesting.com 2022 MRI Textbook Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . "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.