Staff also needs to know specific details about any implants in the body. through the guidewire lumen, other than those required for normal use. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange All stents should be deployed in accordance with the manufacturers indications and instructions for use. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! THE List - MRI Safety The average MRI exam takes about 45 minutes. CAUTION: The law restricts these devices to sale by or on the order of a physician. Bench tests may not be indicative of clinical performance. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. Premarket Submission Number Not Available/Not Released. The SYNERGY. THE List - MRI Safety Data on file. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 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. 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. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. Boston Scientific Announces Results for First Quarter 2023 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. 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. 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. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) 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. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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). Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . outflow obstruction. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 617.638.8000. 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. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. 2023 Boston Scientific Corporation or its affiliates. Never use air or any gaseous medium to inflate the balloon. Directions for Use. We host and take part in events that excel in advancing the world of health. for the treatment of iliofemoral venous occlusive disease. Do not use if pouch is opened or damaged. 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. Find out who we are, explore careers at the company, and view our financial 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. 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. Coils, Filters, Stents, and Grafts More. Data on File. 2023 Boston Scientific Corporation or its affiliates. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Data on file. Several of these demonstrated magnetic field interactions. 2805 0 obj <>stream 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. 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. 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. Find products, medical specialty information, and education opportunities. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. 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. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Find products, medical specialty information, and education opportunities. MRI may not be recommended if for people who have a pacemaker or other metal implants. The Neuroform (Boston Scientific Corporation, Natick, MA) stent is a self-expanding nitinol stent designed to assist the endovascular placement of detachable coils in wide-necked intracranial aneurysms ( 1, 2 ). Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Data on file. Find out who we are, explore careers at the company, and view our financial performance. For decades, we have worked together to define the future. Then the patient is brought out of the scanner. 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 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. 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. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Boston, MA 02118 Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Coils, Filters, Stents, and Grafts More. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. MRI Information for Healthcare Professionals - Boston Scientific THE List - MRI Safety Find products, medical specialty information, and education opportunities. Data on file. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. 1.5,3: Safe More. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare.
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