By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Reproduced with Permission from the GMDN Agency. The ordering physician will go over the findings with their patient. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. Dake, Michael D, et al. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. Allergic/anaphylactic reaction; Amputation; Aneurysm; Arteriovenous fistula; Death related/unrelated to procedure; Dissection; Embolization; Extravasation; Fever; Hemorrhage/bleeding requiring a blood transfusion; Hematoma; Hypotension/hypertension; Incorrect positioning of the stent requiring further stenting or surgery; Intimal injury/dissection; Ischemia/infarction of tissue/organ; Local infection; Malposition (failure to deliver the stent to the intended site); Open surgical repair; Pain; Pulmonary embolism; Pseudoaneurysm; Renal failure; Respiratory arrest; Restenosis; Rupture; Septicemia/bacteremia; Stent Fracture; Stent Migration; Vasospasm; Venous occlusion/thrombosis/restenosis. THE List - MRI Safety Never use air or any gaseous medium to inflate the balloon. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Directions for Use. SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. Recorded at the London Charing Cross Symposium in 2019. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Available in sizes from 1.2 mm to 4.0 mm. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. During system flushing, observe that saline exits at the catheter tip. The compatibility of the device has not been evaluated for the delivery of materials (e.g. All rights reserved. All rights reserved. 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. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Disposable devices intended to assist implantation may be included. Find products, medical specialty information, and education opportunities. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug If difficulty is experienced during balloon inflation, do not continue; remove the catheter. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 2023 Boston Medical Center. Balloon catheter retrieval methods (use of additional wires, snares, and/or forceps) may result in trauma to the treated vessel and/or the vascular access site. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Many exams involve IV contrast, which helps highlight the tissues and give the radiologist different information about an area(s) of interest to help make a diagnosis. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Broadest size matrix of iliofemoral-indicated venous stents in the U.S. Flared ends designed toreduce stent migrationand maximize wall apposition, Designed for use inhigh compressioniliofemoral venous obstructions, Open-cell,flexible designto conform to vessel curvature while maintaining lumen diameter, Highest mean radial resistive forceamong tested iliofemoral venous stents, Tantalum markers forenhanced visibilityunder fluoroscopy, Minimal foreshortening for maximum lesion coverage, Operator control with an ergonomic handle and dual-speed thumbwheels, Primary safety: Freedom from Major Adverse Events (MAE), including stent migrations, at 30 days, Primary Effectiveness: Primary Patency at 12 months, Venous Clinical Severity Score (VCSS) through 36 months. THE List - MRI Safety Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide The image is highly detailed and can show even the smallest abnormality. Premarket Submission Number Not Available/Not Released. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 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. 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. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. Find products, medical specialty information, and education opportunities. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. 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. THE List - MRI Safety Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The SYNERGY. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. To obtain copies images, please call the film library at 617.414.5882. Stents were evaluated at the 36-month follow-up for fracture analysis. 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 Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. Do not use the device after the Use By date specified on the label. To assess the safety and effectiveness of the Venovo Venous Stent For decades, we have worked together to define the future. Find out who we are, explore careers at the company, and view our financial performance. The delivery system is not designed for use with power injection systems. All rights reserved. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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, EMERGE PTCA Dilatation Catheter - Boston Scientific, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Exceptional deliverability and low profiles designed to cross tight lesions, High rated burst pressure 18 ATM (1824 kPa) for sizing flexibility, Two shaft designs provide options for challenging lesions, EMERGE Catheter is designed for exceptional simultaneous use performance, Shaft profile allows for simultaneous use of two Monorail catheters in a 6 F guide catheter and two Over-the-Wire catheters in an 8 F guide catheter*, Designed to optimize stent apposition in large, proximal vessels, Two shaft options with distinct technologies designed to provide flexibility for navigating to and through even the most challenging lesions, Push technology: Single-segment inner shaft design for ultimate pushability 1.2 mm and 1.5 mm Push, Workhorse technology: Bi-Segment inner shaft designed for maximum deliverability without sacrificing pushability (1.2 mm to 4.0 mm). 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. 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 C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Most people are able to complete the exam easily, but for those who are uncomfortable, there are staff trained to assist them in completing the exam through relaxation and visualization techniques. 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. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information The average MRI exam takes about 45 minutes. Safety of Magnetic Resonance Imaging in Patients With - Circulation Do not attempt to break, damage, or disrupt the stent after placement. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Do not expand the balloon if it is not properly positioned in the vessel. Data on file. The safety and effectiveness of this device for use in the arterial system have not been established. A sales representive will get in touch with you shortly. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Store in a cool, dark, dry place. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. 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. 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. One Boston Medical Center Place Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan MRI may not be recommended if for people who have a pacemaker or other metal implants. 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). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. %PDF-1.7 % 2785 0 obj <> endobj ESG (Environmental, Social, and Governance), Policies, Guidelines and Statements Center, Venous disease is complex, your stent choice doesn't have to be, Our live chat is available between the hours of 8.30am - 5.00pm EST, Monday - Friday, BD Original Equipment Manufacturing (OEM), Patient Care Support Across the Continuum, Engineered to provide the optimal balance between radial force, flexibility, and compression resistance, Tri-axial delivery system designed to provide accurate deployment to help facilitate optimal stent placement and lesion coverage, 3mm flared stent ends designed to reduce the risk of stent migration and maximize wall apposition. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). U~ S?)DO(X`dpHpEjq[p10Lv1 Hjer8(,mArFFzMfzSdZn8,=}SGp=!x2|6eCjoVJfPb*K=]Q b?s/=2>I*6yeO-+7Xb{C/^9)#/> # Tu[sS*[eWc!Z9PEPW-OG#*vQJ*U' lK(^>EZoCq8VlS6>s$i \s#zG=?O4E Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 1.5, 3: Conditional 5 More. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Do not use if pouch is opened or damaged. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. MR Safety and Imaging of Neuroform Stents at 3T Note: Boston Scientific Corporation is not responsible for correct use of codes on . The device is typically intended for long-term, but not permanent, implantation. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Results shown as averages measured in N/mm as follows (n=6): Venovo Venous Stent System (0.126), Medtronic Abre Venous Stent (0.1035), Cook Zilver Vena (0.063) and Boston Scientific VICI VENOUS STENT (0.054). Several of these demonstrated magnetic field interactions. We offer diagnosis and treatment in over 70 specialties and subspecialties, as well as programs, services, and support to help you stay well throughout your lifetime. Missing x-ray analyses were recorded as protocol deviations. Fortunately, the devices that exhibited po . The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. endstream endobj startxref MRI also has one exam that uses oral contrast to help visualize the digestive track. alcohol or nitroglycerine, stem cells, etc.) Data on file. Patients having an enterography, may be at BMC up to 3 hours. Reproduced with Permission from the GMDN Agency. 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). Receive Updates. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 2023 Boston Scientific Corporation or its affiliates. A Deeper Dive into the Venovo Venous Stent System, PRESS RELEASE - MAR 14, 2019, PR NEWSWIRE, BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease, One-year data from venous stent registry "promising". This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. GMDN Names and Definitions: Copyright GMDN Agency 2015. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. EMERGE PTCA Dilatation Catheter. 1.5,3: Safe More. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Find out who we are, explore careers at the company, and view our financial performance.
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boston scientific emerge stent mri safety