boston scientific emerge stent mri safety
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Dr. Gerard O'Sullivan, FSIR, FEBIR of Galway University Hospitals in Galway, Ireland and Dr. Steven Dubenec, MBBS, FRACS, Head of Vascular Surgery at the Royal Prince Alfred Hospital in Sydney, Australia discuss important features of the VenovoVenous Stent and their personal experiences using the product. 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). Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. through the guidewire lumen, other than those required for normal use. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). For people having an enterography exam, they will be given an oral contrast as well and will need to wait 2 hours after drinking it to allow it to coat their intestines completely. Boston Medical Center (BMC) is a 514-bed academic medical center located in Boston's historic South End, providing medical care for infants, children, teens and adults. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact. All rights reserved. Once in the scan room, the technologist will explain the exam before it begins and will give the patient ear plugs to muffle the noise the machine makes. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. Receive Updates. The compatibility of the device has not been evaluated for the delivery of materials (e.g. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 2785 0 obj <> endobj Potential adverse events (in alphabetical order) that may be associated with the use of a PTCA Dilatation Catheter include, but are not limited to, the following: Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Then the patient is brought out of the scanner. Store in a cool, dark, dry place. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. 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. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . The Resolute Onyx stent is comprised of a bare metal stent with a Parylene C primer coat and a coating that consists of a blend of the drug zotarolimus and the BioLinx polymer system. The average MRI exam takes about 45 minutes. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. Do not resterilize and/or reuse the device. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. Patients having an enterography, may be at BMC up to 3 hours. Remove the delivery system and replace with a new unit. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Whether youre a current employee or looking to refer a patient, we have the tools and resources you need to help you care for patients effectively and efficiently. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. 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. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). 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 Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. hUmo0+}B~Dx&~XQT,%DN nU|w{p The Venovo Venous Stent System is supplied sterile and is intended for single use only. Fortunately, the devices that exhibited po . All rights reserved. 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. ZGlide hydrophilic coating reduces frictional force on the catheter shaft by 51% in bench tests, Unique, over-the-inner tip design: outer tip material rides over the inner shaft material and is designed to improve overall flexibility and tip performance, Profiles: Ultra-low 0.017 tip profile and 0.026 crossing profile, Balloon Material: OptiLEAP balloon material provides sizing flexibility, Platinum marker bands provide optimal radiopacity. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. Because the MRI has a powerful magnetic field, patients will be screened and checked to make absolutely sure they dont have any metal objects with them before entering the scan room. 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). SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Do not attempt to break, damage, or disrupt the stent after placement. Find products, medical specialty information, and education opportunities. All rights reserved. The patient will be asked to lie on their back or stomach, and should plan to be in the machine for at least 45 minutes in order to complete the exam. Do not use the device with contralateral access. MRI Information For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. The device is typically intended for long-term, but not permanent, implantation. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Polaris Ultra Ureteral Stent Access our instructions for use and product manuals library. Find products, medical specialty information, and education opportunities. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 44, no. endstream endobj 2786 0 obj <>/Metadata 132 0 R/Outlines 189 0 R/Pages 2783 0 R/StructTreeRoot 192 0 R/Type/Catalog/ViewerPreferences 2793 0 R>> endobj 2787 0 obj <>/MediaBox[0 0 288 648]/Parent 2783 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2788 0 obj <>stream 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. The NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters (balloon models 2.00- 5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 170 subjects at 21 sites in the U.S., Europe, and Australia/New Zealand, * Evaluated against literature derived performance goal of 74% for efficacy (p<.0001) and 89% for safety (p=.032), 1The Venovo Venous Stent System was studied in the global VERNACULAR clinical trial, which was a prospective, multi-center, non-randomized, single-arm study of 170 patients. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. Boston Scientific, www.bostonscientific.com . Recorded at the London Charing Cross Symposium in 2019. Dake, Michael D, et al. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. The stent is not designed for repositioning or recapturing.
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