Bench tests may not be indicative of clinical performance. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. 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. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. 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. ESG (Environmental, Social, and Governance), Policies, Guidelines and Statements Center, Venous disease is complex, your stent choice doesn't have to be, Our live chat is available between the hours of 8.30am - 5.00pm EST, Monday - Friday, BD Original Equipment Manufacturing (OEM), Patient Care Support Across the Continuum, Engineered to provide the optimal balance between radial force, flexibility, and compression resistance, Tri-axial delivery system designed to provide accurate deployment to help facilitate optimal stent placement and lesion coverage, 3mm flared stent ends designed to reduce the risk of stent migration and maximize wall apposition. 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. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. 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. Disposable devices intended to assist implantation may be included. o. NC EMERGE PTCA Dilatation Catheter - Boston Scientific Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan 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. 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. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. PDF Summary of Safety and Effectivness (SSED)Template THE List - MRI Safety 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. 1.5,3: Safe More. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Do not expand the balloon if it is not properly positioned in the vessel. One Boston Medical Center Place 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. AccessGUDID - DEVICE: Tria Soft (08714729959915) Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. The SYNERGY. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. GMDN Names and Definitions: Copyright GMDN Agency 2015. Once the test has been completed people can return home and resume normal activities. EMERGE PTCA Dilatation Catheter. 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. To assess the safety and effectiveness of the Venovo Venous Stent 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). BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP 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. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 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. THE List - MRI Safety 98 subjects x-rays were analyzed and no stent fractures were reported. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. The average MRI exam takes about 45 minutes. 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. AccessGUDID - DEVICE: Ascerta (08714729802976) 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). 1.5 . All rights reserved. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Bench test results may not necessarily be indicative of clinical performance. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. If excessive force is felt during stent deployment, do not force the delivery system. 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 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. The compatibility of the device has not been evaluated for the delivery of materials (e.g. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Fortunately, the devices that exhibited po . Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. All other trademarks are the property of their respective owners. Coils, Filters, Stents, and Grafts More. All rights reserved. CAUTION: The law restricts these devices to sale by or on the order of a physician. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 2023 Boston Scientific Corporation or its affiliates. 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. 2023 Boston Scientific Corporation or its affiliates. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. All rights reserved. Different test methods may yield different results. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 617.638.8000. 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. All rights reserved. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Find products, medical specialty information, and education opportunities. 44, no. $ fG1012p("3| 2 EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. MRI Information for Healthcare Professionals - Boston Scientific The device is typically intended for long-term, but not permanent, implantation. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Epub 2021 Sep 20. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Magnetic Resonance Imaging (MRI) | Boston Medical Center 0 This site is Exclusively Sponsored by BRACCO. 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 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 C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Data on file. Reproduced with Permission from the GMDN Agency. Data on file. through the guidewire lumen, other than those required for normal use. Receive Updates. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. outflow obstruction. Data on file. 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. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. 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. 2023 Boston Scientific Corporation or its affiliates. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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). The ordering physician will go over the findings with their patient. 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. Access our instructions for use and product manuals library. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. 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.

Deaths Pembroke, Massachusetts, Unfictional Falling Podcast Transcript, Cameron County Case Search Portal, Articles B