boston scientific emerge stent mri safety

All rights reserved. 2023 Boston Scientific Corporation or its affiliates. There is no preparation necessary for an MRI except for people having an exam called an MRCP, an exam of the gallbladder and the ducts associated with it, or an enterography. MRI is a more detailed tool than x-ray and ultrasound and for certain organs or areas of the body, it provides better images than CT. Bench tests may not be indicative of clinical performance. endstream endobj startxref The technologist performing the exam will monitor the patient throughout the scan and they are also able to talk with each other the entire time. Data on file. Safety of Magnetic Resonance Imaging in Patients With - Circulation There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. 2=[DE8m|E23 jIrL|bW30+;$12r+e5Jl+]pVIn[Ndck0xc$VVq+9e'0")m275ahsk8/` $4,,:8X3@$3h` u40y@p ` i;+:dXf`6@,ohH=`)35^7;7>n`pRwg 1hQb`br&Y' 6G 98 subjects x-rays were analyzed and no stent fractures were reported. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Different test methods may yield different results. For more information about these cookies and the data collected, please refer to our, Laboratory and Biorepository Research Services Core, Pediatric Exams with and without conscious sedation. Primary Patency by Kaplan-Meier estimates at 36 months are 84.0% for the total population (N=170), 74.8% for subjects with post-thrombotic syndrome (N=93) and 95.5% for subjects with non-thrombotic iliac vein lesions. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. 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. EMERGE PTCA Dilatation Catheter. 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861720 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 Receive Updates. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. For decades, we have worked together to define the future. Recorded at the London Charing Cross Symposium in 2019. MARLBOROUGH, Mass., April 26, 2023 / PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational 1 basis and 14.0 percent on an organic 2 basis, all compared to the prior year period. This depends on the exam the doctor has ordered. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Find out who we are, explore careers at the company, and view our financial performance. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. AccessGUDID - DEVICE: Tria Soft (08714729959915) Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. The NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. The image is highly detailed and can show even the smallest abnormality. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 850 W Rio Salado Pkwy, Tempe, AZ 85281 United States, 6:00 a.m. 4:30 p.m. Arizona Time (Monday-Friday), Surgical Instruments and Sterilization Container products. Available in sizes from 1.2 mm to 4.0 mm. Wallstent EndoprosthesisMagic Wallstent3.5 x 25coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Wallstent EndoprosthesisWith Permalume covering8 x 80coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Wallstent Esophageal II Endoprosthesis20 x 130coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, WALLSTENT RX Biliary EndoprosthesisBoston Scientifichttp://www.bostonscientific.com, WALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com, WallStentcarotid artery stentBoston Scientific CorporationMaple Grove, MN, Wallstentplatinum and cobalt-alloycoil, stent, filterSchneiderBulach, Switzerland, Walvekar Salivary Duct StentHood Laboratories, www.hoodlabs.com, Watchman Gen 4 ImplantAtritech Inc. and Boston Scientific, www.bostonscientific.com, Watchman Left Atrial Appendage Closure DeviceAtritech Inc. and Boston Scientific, www.bostonscientific.com, WEB Aneurysm Embolization Device Sequent Medical, Inc./Microvention, www.microvention.com, Weck Horizon, Titanium Clip, All sizes Teleflex Medical, www.teleflex.com, WedgeLoc Suture Anchor with Opti-Fiber SuturesMedShape SolutionsAtlanta, GA, WedgeLoc Suture AnchorMedShape Solutions, Inc.Atlanta, GA, Wehrs Incus Prosthesis, Otologic ImplantGyrus ACMI, www.gyrusacmi.com, WessexAortic, Model WAV10heart valveSorin BiomedicaItaly, WessexMitral, Model WMV20heart valveSorin BiomedicaItaly, Westaby T-Y StentHood Laboratories, www.hoodlabs.com, Western EZ-OX Plus SystemALQ-2342 on an Aluminum D cylinderWestern EnterprisesWestlake, OH. If excessive force is felt during stent deployment, do not force the delivery system. Several of these demonstrated magnetic field interactions. 1.5,3: Safe More. We host and take part in events that excel in advancing the world of health. 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. MR Safety and Imaging of Neuroform Stents at 3T PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 0 MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Note: Boston Scientific Corporation is not responsible for correct use of codes on . In addition to this commitment, our robust research and teaching programs keep our hospital on the cutting-edge, while pushing medical care into the future. Find products, medical specialty information, and education opportunities. To obtain copies images, please call the film library at 617.414.5882. Directions for Use. The average MRI exam takes about 45 minutes. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . Do not exceed the balloon rated burst pressure. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Venovo Venous Stent System - BD Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, *6 F guide catheter with a minimum 0.070" ID, 8 F guide catheter with a minimum 0.088" ID, See all healthcare professional information, 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, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Improves overall flexibility and performance in tortuous anatomy, Outer tip material rides over the inner shaft, Designed to improve overall flexibility and tip performance, Short tip designed to lessen tip catch occurrence and offer greater control, Designed for exceptional simultaneous use performance, Reduced frictional force on the catheter shaft, Both stiff and flexible segments to enhance pushability and trackability, One piece outer shaft provides a seamless transition, Designed for less balloon growth and increased rated, Unique blend of balloon materials provides excellent, Provides optimal radiopacity and excellent visibility. Boston Scientific Announces Results for First Quarter 2023 If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. MRI is a more detailed tool than x-ray and ultrasound and for certain organs or areas of the body, it provides better images than CT. People who are claustrophobic, should consult their physician prior to the day of the appointment for assistance, as the department is not licensed to dispense medication. The Neuroform (Boston Scientific Corporation, Natick, MA) stent is a self-expanding nitinol stent designed to assist the endovascular placement of detachable coils in wide-necked intracranial aneurysms ( 1, 2 ). See all healthcare professional information, 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, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. endstream endobj 2789 0 obj <>stream Reproduced with Permission from the GMDN Agency. The ordering physician will go over the findings with their patient. ;;>BFZQC. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Dr. Michael Dake, Senior VP for Health Sciences at the University of Arizona and Principal Investigator in the VenovoVenous Stent VERNACULAR trial shares key findings from the 24-month clinical results including primary patency rates, target lesion revascularization (TLR) and fracture rates, patient quality of life, and more. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Do not resterilize and/or reuse the device. Reuse, resterilization, reprocessing and/or repackaging may create a risk to the patient or user, may lead to infection or compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient. Kaplan-Meier Primary Patency in Post-Thrombotic Lesions at 36 months, Kaplan-Meier Primary Patency in Non-Thrombotic Lesions at 36 months, Freedom from Target Lesion Revascularization (TLR) at 36 months.

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