boston scientific emerge stent mri safety

EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. A sales representive will get in touch with you shortly. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. MR Safety and Imaging of Neuroform Stents at 3T With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Testing completed by Boston Scientific Corporation. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. CAUTION: The law restricts these devices to sale by or on the order of a physician. To assess the safety and effectiveness of the Venovo Venous Stent Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). through the guidewire lumen, other than those required for normal use. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide 44, no. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . hUmo0+}B~Dx&~XQT,%DN nU|w{p 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. NC EMERGE PTCA Dilatation Catheter - Boston Scientific The Venovo Venous Stent System is supplied sterile and is intended for single use only. 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. Primary Patency by Kaplan-Meier estimates at 36 months are 84.0% for the total population (N=170), 74.8% for subjects with post-thrombotic syndrome (N=93) and 95.5% for subjects with non-thrombotic iliac vein lesions. 1.5,3: Safe More. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. To obtain copies images, please call the film library at 617.414.5882. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. AccessGUDID - DEVICE: Tria Soft (08714729959915) 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. 2023 Boston Scientific Corporation or its affiliates. Missing x-ray analyses were recorded as protocol deviations. Many exams involve IV contrast, which helps highlight the tissues and give the radiologist different information about an area(s) of interest to help make a diagnosis. Dake, Michael D, et al. If excessive force is felt during stent deployment, do not force the delivery system. Find products, medical specialty information, and education opportunities. NC EMERGE Indications, Safety, and Warnings - Boston Scientific MRI exams require people to lie still for the entire length of the study. 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. Fortunately, the devices that exhibited po . Patients having an enterography, may be at BMC up to 3 hours. 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 Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 98 subjects x-rays were analyzed and no stent fractures were reported. Data on file. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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). BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. Find out who we are, explore careers at the company, and view our financial performance. Stents were evaluated at the 36-month follow-up for fracture analysis. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! This site is Exclusively Sponsored by BRACCO. Once the test has been completed people can return home and resume normal activities. 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. 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 Epub 2021 Sep 20. 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). All rights reserved. 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. Remove the delivery system and replace with a new unit. Find out who we are, explore careers at the company, and view our financial performance. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. 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 SYNERGY. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. 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. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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 C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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. 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). Prior to stent deployment, remove slack from the delivery system catheter outside the patient. Boston Scientific, www.bostonscientific.com . Use only the recommended balloon inflation medium. 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. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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. Boston Scientific Announces Results for First Quarter 2023 Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. The compatibility of the device has not been evaluated for the delivery of materials (e.g. 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. 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 Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. All rights reserved. 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. Kaplan-Meier Primary Patency in Post-Thrombotic Lesions at 36 months, Kaplan-Meier Primary Patency in Non-Thrombotic Lesions at 36 months, Freedom from Target Lesion Revascularization (TLR) at 36 months. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. 2785 0 obj <> endobj Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Bench test results may not necessarily be indicative of clinical performance. 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. Find products, medical specialty information, and education opportunities. Find out who we are, explore careers at the company, and view our financial performance. Directions for Use. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. During system flushing, observe that saline exits at the catheter tip. 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. 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. PDF Summary of Safety and Effectivness (SSED)Template Venovo Venous Stent System - BD Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Polaris Ultra Ureteral Stent Magnetic Resonance Imaging (MRI) | Boston Medical Center 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. Do not expand the balloon if it is not properly positioned in the vessel. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.

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