GMDN Names and Definitions: Copyright GMDN Agency 2015. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Patients having an enterography, may be at BMC up to 3 hours. 44, no. 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. Bench test results may not necessarily be indicative of clinical performance. 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. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). 2023 Boston Scientific Corporation or its affiliates. Then the patient is brought out of the scanner. EMERGE PTCA Dilatation Catheter. The Freedom from TLR rate at 36 months was 88.1%. 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. 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. 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. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. Data on file. Data on File. 2805 0 obj
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Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . 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. If excessive force is felt during stent deployment, do not force the delivery system. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. A sales representive will get in touch with you shortly. This site is Exclusively Sponsored by BRACCO. 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. 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. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston, MA 02118 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. Reproduced with Permission from the GMDN Agency. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Once the test has been completed people can return home and resume normal activities. hUmo0+}B~Dx&~XQT,%DN nU|w{p BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Magnetic Resonance Imaging (MRI) | Boston Medical Center Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. 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. The ordering physician will go over the findings with their patient. Choose from Monorail and Over-the-Wire Catheter options. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. Data on file. All rights reserved. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. The Venovo Venous Stent System is supplied sterile and is intended for single use only. 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. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . We are committed to providing the best experience possible for our patients and visitors. PDF Summary of Safety and Effectivness (SSED)Template The long-term outcomes following repeat dilatation of endothelialized stents are unknown. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. BD and the BD Logo are trademarks of Becton, Dickinson and Company. 1.5 . MRI also has one exam that uses oral contrast to help visualize the digestive track. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. *(c5PH
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Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 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. o. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. Several of these demonstrated magnetic field interactions. The delivery system is not designed for use with power injection systems. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! Venovo Venous Stent System - BD 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. 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. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Find out who we are, explore careers at the company, and view our financial performance. 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 List - MRI Safety Bench test results may not necessarily be indicative of clinical performance. endstream
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The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. This depends on the exam the doctor has ordered. outflow obstruction. Safety of Magnetic Resonance Imaging in Patients With - Circulation PDF VICI VENOUS STENT System Instructions for Use - Food and Drug $
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Several of these demonstrated magnetic field interactions. 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 Venovo Venous Stent System is contraindicated for use in patients with a known hypersensitivity to nitinol (nickel-titanium) and tantalum, who cannot receive intraprocedural anti-coagulation therapy, or who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). 2023 BD. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm.
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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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 NC EMERGE Indications, Safety, and Warnings - Boston Scientific Do not expose the delivery system to organic solvents, e.g., alcohol. Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide 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). If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous
EMERGE PTCA Dilatation Catheter - Boston Scientific Data on file. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . 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. 2792 0 obj
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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. hbbd```b``>"tH/ Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. The stent is not designed for repositioning or recapturing. The NC Emerge PTCA Dilatation Catheter is contraindicated for use in: PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA as treatment of this patient population carries special risk.