GMDN Names and Definitions: Copyright GMDN Agency 2015. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange Brand Name: Polaris Ultra Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729754565 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Ureteral Stent Polaris Ultra - Device Characteristics Polaris Ultra - GMDN Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. 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. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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. Once the test has been completed people can return home and resume normal activities. 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. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Directions for Use. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Data on file. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q 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 Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. Testing completed by Boston Scientific Corporation. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. PDF Summary of Safety and Effectivness (SSED)Template Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. %%EOF BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. 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 MR Safety and Imaging of Neuroform Stents at 3T The compatibility of the device has not been evaluated for the delivery of materials (e.g. Find products, medical specialty information, and education opportunities. CAUTION: The law restricts these devices to sale by or on the order of a physician. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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 safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. We host and take part in events that excel in advancing the world of health. 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. Several of these demonstrated magnetic field interactions. Disposable devices intended to assist implantation may be included. 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. 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. 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). Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. 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. Reproduced with Permission from the GMDN Agency. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 98 subjects x-rays were analyzed and no stent fractures were reported. 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. The device is typically intended for long-term, but not permanent, implantation. hbbd```b``>"tH/ 44, no. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. 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. 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 ). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. To assess the safety and effectiveness of the Venovo Venous Stent *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Disposable devices intended to assist implantation may be included. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. Coils, Filters, Stents, and Grafts More. 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. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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). Safety of Magnetic Resonance Imaging in Patients With - Circulation All stents should be deployed in accordance with the manufacturers indications and instructions for use. Receive Updates. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 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 Do not exceed the balloon rated burst pressure. 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. Data on file. hUmo0+}B~Dx&~XQT,%DN nU|w{p 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. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. 2023 BD. Boston Scientific Announces Results for First Quarter 2023 MRI also has one exam that uses oral contrast to help visualize the digestive track. The Freedom from TLR rate at 36 months was 88.1%. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . 1.5, 3: Conditional 5 More. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). All rights reserved. 0 People who are claustrophobic, should consult their physician prior to the day of the appointment for assistance, as the department is not licensed to dispense medication. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. 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. 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. Boston, MA 02118 To obtain copies images, please call the film library at 617.414.5882. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. 2792 0 obj <>/Filter/FlateDecode/ID[<8422C93A02CE4B499E7EC15CE70ACD24>]/Index[2785 21]/Info 2784 0 R/Length 60/Prev 713660/Root 2786 0 R/Size 2806/Type/XRef/W[1 3 1]>>stream Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. 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. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products.
Spiritual Roots Of Foot Pain, Articles B