All rights reserved. Coronary artery spasm in the absence of a significant stenosis. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Coils, Filters, Stents, and Grafts More. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. CAUTION: The law restricts these devices to sale by or on the order of a physician. Epub 2021 Sep 20. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 98 subjects x-rays were analyzed and no stent fractures were reported. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Do not expand the balloon if it is not properly positioned in the vessel. Reusing this medical device bears the risk of cross-patient contamination as medical devices particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. Bench test results may not necessarily be indicative of clinical performance. Disposable devices intended to assist implantation may be included. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. All rights reserved. All rights reserved. Several of these demonstrated magnetic field interactions. Fortunately, the devices that exhibited po . Staff also needs to know specific details about any implants in the body. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 4.8 F Stent Diameter, Device Size Text, specify: 24 cm Effective Length, Device Size Text, specify: 1.6 mm Stent Diameter. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Stents were evaluated at the 36-month follow-up for fracture analysis. To assess the safety and effectiveness of the Venovo Venous Stent 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The delivery system is not designed for use with power injection systems. MR Safety and Imaging of Neuroform Stents at 3T Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Find out who we are, explore careers at the company, and view our financial performance. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. Premarket Submission Number Not Available/Not Released. Safe MR imaging involves a careful initial patient screening, accurate determination of the permanent implanted or temporary cardiovascular device and its properties, a thoughtful analysis of the risks and benefits of performing the examination at that time, and, when indicated, appropriate physician management and supervision. THE List - MRI Safety PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange Choose from Monorail and Over-the-Wire Catheter options. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Data on file. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure).
