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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. 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. 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. %PDF-1.7 % BMC physicians are leaders in their fields with the most advanced medical technology at their fingertips and working alongside a highly skilled nursing and professional staff. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Data on file. Receive Updates. outflow obstruction. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Find products, medical specialty information, and education opportunities. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Patients having an enterography, may be at BMC up to 3 hours. All rights reserved. Testing completed by Boston Scientific Corporation. Boston Scientific, www.bostonscientific.com . Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Reproduced with Permission from the GMDN Agency. 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. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 2805 0 obj <>stream The Freedom from TLR rate at 36 months was 88.1%. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. %%EOF Do not use the device with contralateral access. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. All rights reserved. Find out who we are, explore careers at the company, and view our financial performance. The average MRI exam takes about 45 minutes. All rights reserved. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. Data on file. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. endstream endobj startxref Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. The device is typically intended for long-term, but not permanent, implantation. 2023 BD. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 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 Premarket Submission Number Not Available/Not Released. endstream endobj 2789 0 obj <>stream Available in sizes from 1.2 mm to 4.0 mm. Directions for Use. Several of these demonstrated magnetic field interactions. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Then the patient is brought out of the scanner. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. The primary effectiveness endpoint of the study was primary patency (PP) at 12 months post-index procedure, defined as: freedom from TVR and freedom from thrombus occlusion and stenosis > 50% as measured by DUS. Do not use the device after the Use By date specified on the label. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 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. 3Foreshortening is calculated as the difference, represented as percentage, between the compressed stent length and expanded stent length at minimum/maximum oversize (1-3 mm). Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Do not expose the delivery system to organic solvents, e.g., alcohol. GMDN Names and Definitions: Copyright GMDN Agency 2015. The safety and effectiveness of this device for use in the arterial system have not been established. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Data on file. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. 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. Data on File. The ordering physician will go over the findings with their patient. 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. 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 $ fG1012p("3| 2 Do not expand the balloon if it is not properly positioned in the vessel. All rights reserved. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. 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. All other trademarks are the property of their respective owners. Once the test has been completed people can return home and resume normal activities. Stents were evaluated at the 36-month follow-up for fracture analysis. For decades, we have worked together to define the future. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. The stent is not designed for repositioning or recapturing. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. 617.638.8000. Coils, Filters, Stents, and Grafts More. The SYNERGY. for the treatment of iliofemoral venous occlusive disease. This depends on the exam the doctor has ordered. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Find out who we are, explore careers at the company, and view our financial performance. 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. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. If excessive force is felt during stent deployment, do not force the delivery system. Bench tests may not be indicative of clinical performance. All rights reserved. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. 2785 0 obj <> endobj The delivery system is not designed for use with power injection systems. Disposable devices intended to assist implantation may be included. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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 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. Dake, Michael D, et al. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. 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. 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. 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. 2023 Boston Scientific Corporation or its affiliates. 2023 Boston Scientific Corporation or its affiliates. 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. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Find out who we are, explore careers at the company, and view our financial performance. Bench test results may not necessarily be indicative of clinical performance. Results demonstrated 100% acute technical success, defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator at the time of the index procedure. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Find products, medical specialty information, and education opportunities. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. arrhythmia, including ventricular fibrillation, coronary vessel dissection, perforation, rupture or injury, possibly requiring surgical repair or intervention, drug reactions, including allergic reaction to contrast medium, total occlusion of the coronary artery or bypass graft, vessel trauma requiring surgical repair or intervention, 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. Do not attempt to break, damage, or disrupt the stent after placement. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 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. 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. 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. 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. Fortunately, the devices that exhibited po . 1 The 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. Different test methods may yield different results. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. Store in a cool, dark, dry place. CAUTION: The law restricts these devices to sale by or on the order of a physician. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). 1.5, 3: Conditional 5 More. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Missing x-ray analyses were recorded as protocol deviations. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. ;;>BFZQC. Find products, medical specialty information, and education opportunities. Bench test results may not necessarily be indicative of clinical performance. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. 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. Patients who received a Venovo Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.7% PP rate for subjects with post-thrombotic syndrome and 97.1% PP rate for subjects with non-thrombotic iliac vein lesions. Data on file. MRI also has one exam that uses oral contrast to help visualize the digestive track. To assess the safety and effectiveness of the Venovo Venous Stent hUmo0+}B~Dx&~XQT,%DN nU|w{p MRI exams require people to lie still for the entire length of the study. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. Testing completed by Boston Scientific Corporation. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. Several of these demonstrated magnetic field interactions. We host and take part in events that excel in advancing the world of health. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis. The device is typically intended for long-term, but not permanent, implantation. Use only the recommended balloon inflation medium. 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). Prior to stent deployment, remove slack from the delivery system catheter outside the patient. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Data on file. hbbd```b``>"tH/ The compatibility of the device has not been evaluated for the delivery of materials (e.g. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 2023 Boston Medical Center. Coronary artery spasm in the absence of a significant stenosis. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. During system flushing, observe that saline exits at the catheter tip. Do not resterilize and/or reuse the device. Recorded at the London Charing Cross Symposium in 2019. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. Disposable devices intended to assist implantation may be included. 1.5,3: Safe More. At the 36-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -16.8 and, for the VCSS Pain score, a change from baseline in the total population of -1.8. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 0 GMDN Names and Definitions: Copyright GMDN Agency 2015. Data on file, BD Peripheral Intervention, Tempe, AZ. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. PMA Applicant: Boston Scientific Corporation Address: One Scimed Place, Maple Grove, MN 55311-1566 Approval Date: August 11, 2020 Approval Letter: Approval Order What is it? To obtain copies images, please call the film library at 617.414.5882. Coils, Filters, Stents, and Grafts More. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. One Boston Medical Center Place 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.
Why Do Babies Clap Their Feet,
Frenkie De Jong Y Luuk De Jong Son Hermanos,
Cronus Zen Aimbot,
The Killers Imploding The Mirage Tour,
Articles B