The Freedom from TLR rate at 36 months was 88.1%. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 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 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. alcohol or nitroglycerine, stem cells, etc.) through the guidewire lumen, other than those required for normal use. 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. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Disposable devices intended to assist implantation may be included. To assess the safety and effectiveness of the Venovo Venous Stent C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The image is highly detailed and can show even the smallest abnormality. 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 Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Find out who we are, explore careers at the company, and view our financial performance. 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. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). The compatibility of the device has not been evaluated for the delivery of materials (e.g. Staff also needs to know specific details about any implants in the body. Magnetic Resonance Imaging (MRI) | Boston Medical Center MRI exams require people to lie still for the entire length of the study. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. 2023 Boston Scientific Corporation or its affiliates. Receive Updates. Several of these demonstrated magnetic field interactions. All rights reserved. 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. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . 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. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. If excessive force is felt during stent deployment, do not force the delivery system. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. Access our instructions for use and product manuals library. Fortunately, the devices that exhibited po . 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. Different test methods may yield different results. 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. 2023 Boston Scientific Corporation or its affiliates. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. 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. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Data on file. Boston, MA 02118 Boston Scientific, www.bostonscientific.com . Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Recorded at the London Charing Cross Symposium in 2019. Epub 2021 Sep 20. 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). This site is Exclusively Sponsored by BRACCO. 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. 1.5, 3: Conditional 5 More. All rights reserved. During system flushing, observe that saline exits at the catheter tip. 617.638.8000. 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. MR Safety and Imaging of Neuroform Stents at 3T Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Coronary artery spasm in the absence of a significant stenosis. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. %PDF-1.7 % hUmo0+}B~Dx&~XQT,%DN nU|w{p *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. MRI may not be recommended if for people who have a pacemaker or other metal implants. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 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). Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Dake, Michael D, et al. Do not resterilize and/or reuse the device. 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. A patient with the VICI VENOUS STENT can be scanned safely, immediately after placement, in an MR system meeting the following conditions: o Static magnetic field of 1.5 T or 3.0 T only. 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. Directions for Use. 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). The average MRI exam takes about 45 minutes. Once the test has been completed people can return home and resume normal activities. NC EMERGE PTCA Dilatation Catheter - Boston Scientific 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. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. A sales representive will get in touch with you shortly. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). GMDN Names and Definitions: Copyright GMDN Agency 2015. Missing x-ray analyses were recorded as protocol deviations. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan $ fG1012p("3| 2 Testing completed by Boston Scientific Corporation. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Choose from Monorail and Over-the-Wire Catheter options. %%EOF The stent is not designed for repositioning or recapturing. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. MRI Information for Healthcare Professionals - Boston Scientific All stents should be deployed in accordance with the manufacturers indications and instructions for use. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. The SYNERGY. 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. endstream endobj startxref Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Find out who we are, explore careers at the company, and view our financial performance. 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. 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. 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. Data on file. Data on file. 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. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. This depends on the exam the doctor has ordered. 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. Find products, medical specialty information, and education opportunities. 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. Several of these demonstrated magnetic field interactions. THE List - MRI Safety Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Do not use the device after the Use By date specified on the label. Data on file. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. 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. 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. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. 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. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Data on file. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. The delivery system is not designed for use with power injection systems. Patients having an enterography, may be at BMC up to 3 hours. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. All other trademarks are the property of their respective owners. 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. Venovo Venous Stent System - BD Do not expose the delivery system to organic solvents, e.g., alcohol. All rights reserved. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. Disposable devices intended to assist implantation may be included. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Safety of Magnetic Resonance Imaging in Patients With - Circulation 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. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. 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".
Can Police Recover Deleted Telegram Messages, City Of Davis Ok Water Department, Articles B