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When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . 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. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. 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). 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. 1 0 obj << /Creator (Venous Wallstent SSED vers 2 - Microsoft Word) /CreationDate (D:20020508130644Z) /Title (P980033) /Author (Author: ODE) /Producer (Acrobat PDFWriter 5.0 for Windows NT) /Subject (Issue: 11-16-2001) /Keywords (Posted: 05-08-2002) /ModDate (D:20020508134926-03'00') >> endobj 2 0 obj [ /PDF /Text ] endobj 3 0 obj << /Pages 60 0 R /Type /Catalog /Metadata 87 0 R >> endobj 4 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 8 0 R /F2 10 0 R /F3 12 0 R >> /ProcSet 2 0 R >> /Contents 14 0 R /Thumb 65 0 R >> endobj 5 0 obj << /Kids [ 4 0 R 16 0 R 21 0 R 27 0 R 30 0 R 36 0 R ] /Count 6 /Type /Pages /Parent 60 0 R >> endobj 6 0 obj << /Type /Font /Subtype /TrueType /Name /F0 /BaseFont /TimesNewRoman /FirstChar 32 /LastChar 255 /Widths [ 250 333 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Safety of Magnetic Resonance Imaging in Patients With - Circulation 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. {}(;]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? AccessGUDID - DEVICE: Tria Soft (08714729959915) Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. 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. PDF Summary of Safety and Effectivness (SSED)Template This press release contains forward-looking statements. Dont scan the patient if any adverse conditions are present. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel This site uses cookies. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. 2022 Boston Scientific Corporation or its affiliates. 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. The information provided here is not intended to provide information to patients and the general public. Follow the checklist instructions within Merlin PCS Programmer. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Find products, medical specialty information, and education opportunities. AccessGUDID - DEVICE: Epic Vascular (08714729805014) Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. The Boston Scientific Epic Stent Continues to Demonstrate Positive 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 [?] (0.89mm) guidewires. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 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. 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. 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. 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. Before sharing sensitive information, make sure you're on a federal government site. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep 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. PDF Summary of Safety and Effectiveness 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. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Epic Vascular Self-Expanding Stent System - Boston Scientific PDF Summary of Safety and Effectiveness Data (Ssed) 0.3. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. PDF Table of Contents - WATCHMAN 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. If the stent migrates to the heart, it could cause life-threatening injury. 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 [?] THE List - MRI Safety Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Proper patient monitoring must be provided during the MRI scan. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 1.5,3: Conditional 5 More . Drummond wire (316L SS) orthopedic implant. 1.5 . We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. The MRI parameter settings are selected at the physician's discretion. All rights reserved. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Use this database for coronary intervention, peripheral intervention and valve repair products. Newmatic Medical, www.newmaticmedical.com. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Read our privacy policy to learn more. 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: Orthopedic Implants, Materials, and Devices More. This site is Exclusively Sponsored by BRACCO. 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. 86 0 obj <>/Encrypt 60 0 R/Filter/FlateDecode/ID[<7D8C813C4252734AB79DD3D747A7C1DD><1D49B7B49C69E9479F78B175C988B6B0>]/Index[59 63]/Length 120/Prev 229479/Root 61 0 R/Size 122/Type/XRef/W[1 2 1]>>stream MRI safety testing has shown that the REBEL Stent is MR Conditional and that 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 how data will be handled by each system. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Magnetic Resonance MR Conditional 3.0 tesla temperature information Marlborough, MA 01752-1566 . "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.