boston scientific epic stent mri safetyshriner funeral ritual

CAUTION: These products are intended for use by or under the direction of a physician. 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. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. (0.89mm) guidewires. 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. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. 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. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel 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. 2022 Boston Scientific Corporation or its affiliates. 1.5,3: 1.5 . AccessGUDID - DEVICE: Ascerta (08714729802976) Metal Expandable Biliary Stents - Food and Drug Administration These devices are considered MR Unsafe. Drummond wire (316L SS) orthopedic implant. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . 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. 59 0 obj <> endobj Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. "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.". 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. Epic Vascular Self-Expanding Stent System - Boston Scientific All rights reserved. Several of these demonstrated magnetic field interactions. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. This site uses cookies. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. %PDF-1.5 % 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. @Bd!$7@"rAOgx The stent is constrained within a 6F delivery system. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). PDF Platinum Chromium Coronary Stent System REBEL - Food and Drug AccessGUDID - DEVICE: Epic Vascular (08714729805014) The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Introduction II. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes Use of these devices may cause serious injuries or death. Coils, Filters, Stents, and Grafts More. If a device is not shown in the list, it is not MR Conditional. 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. Epic Stent Boston Scientific, www.bostonscientific.com. The site is secure. The information provided here is not intended to provide information to patients and the general public. Sterile. MRI safety testing has shown that the REBEL Stent is MR Conditional and that 0.3. endstream endobj startxref Coils, Filters, Stents, and Grafts More. Find products, medical specialty information, and education opportunities. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Proper patient monitoring must be provided during the MRI scan. (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 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 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. As the stent is exposed to body temperature it expands to appose the duct wall. These devices are considered MR Unsafe. Catalog No. For more information, please visit: www.bostonscientific.com. PDF Table of Contents - WATCHMAN Note: If you need help accessing information in different file formats, see Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 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. PDF 2 7 2 Epic Vascular 2 - Boston Scientific Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Search for arrhythmia, heart failure and structural heart IFUs. 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. The Sentinol Nitinol Stent System is comprised of two components: the implantable . Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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: The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. The results found that the stent was MRI . The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) 38948-8607. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 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. 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. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. 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. Marlborough, MA 01752-1566 . 2023 Boston Scientific Corporation or its affiliates. Overview of the ELUVIA Drug- Eluting Stent (DES) III. PDF Summary of Safety and Effectivness (SSED)Template H7YPnf'Sq-. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. 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. 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. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. Boston Scientific Corporation . THE List - MRI Safety Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Use this database for arrhythmia, heart failure and structural heart products. THE List - MRI Safety Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Reproduced with Permission from the GMDN Agency. Catalog No. THE List - MRI Safety Dont scan the patient if any adverse conditions are present. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE All rights reserved. of Abbott Medical Japan GK. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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).

How Long Is Frosting Good For After Expiration Date, Candidate Characteristics Ap Gov, Permanent Living Caravan Parks Victoria, Personal Disorganization In Sociology Ppt, Articles B