BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. EMERGE PTCA Dilatation Catheter - Boston Scientific C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Do not exceed the balloon rated burst pressure. 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. 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). Recorded at the London Charing Cross Symposium in 2019. 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. Coils, Filters, Stents, and Grafts More. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 2023 BD. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug Bench test results may not necessarily be indicative of clinical performance. One Boston Medical Center Place The device is intended for use by physicians who have received appropriate training. Coronary artery spasm in the absence of a significant stenosis. 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. 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. The average MRI exam takes about 45 minutes. Stents were evaluated at the 36-month follow-up for fracture analysis. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Fortunately, the devices that exhibited po . Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Data on file. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. The ordering physician will go over the findings with their patient. Bench tests may not be indicative of clinical performance. THE List - MRI Safety 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. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Results shown as averages measured in N/mm as follows (n=6): Venovo Venous Stent System (0.126), Medtronic Abre Venous Stent (0.1035), Cook Zilver Vena (0.063) and Boston Scientific VICI VENOUS STENT (0.054). All rights reserved. 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. THE List - MRI Safety Find out who we are, explore careers at the company, and view our financial performance. Find out who we are, explore careers at the company, and view our financial performance. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Do not use if pouch is opened or damaged. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. outflow obstruction. 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 ). The compatibility of the device has not been evaluated for the delivery of materials (e.g. All rights reserved. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, *6 F guide catheter with a minimum 0.070" ID, 8 F guide catheter with a minimum 0.088" ID, 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, Improves overall flexibility and performance in tortuous anatomy, Outer tip material rides over the inner shaft, Designed to improve overall flexibility and tip performance, Short tip designed to lessen tip catch occurrence and offer greater control, Designed for exceptional simultaneous use performance, Reduced frictional force on the catheter shaft, Both stiff and flexible segments to enhance pushability and trackability, One piece outer shaft provides a seamless transition, Designed for less balloon growth and increased rated, Unique blend of balloon materials provides excellent, Provides optimal radiopacity and excellent visibility. 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 residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 4.8 F Stent Diameter, Device Size Text, specify: 24 cm Effective Length, Device Size Text, specify: 1.6 mm Stent Diameter. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. Reproduced with Permission from the GMDN Agency. Find products, medical specialty information, and education opportunities. Different test methods may yield different results. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Data on file, BD Peripheral Intervention, Tempe, AZ. 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. 2023 Boston Scientific Corporation or its affiliates. AccessGUDID - DEVICE: Tria Soft (08714729959915) Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. All other trademarks are the property of their respective owners. Do not expose the delivery system to organic solvents, e.g., alcohol. 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. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. 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. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. ;;>BFZQC. The device is typically intended for long-term, but not permanent, implantation. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. During system flushing, observe that saline exits at the catheter tip. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. 0 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. MRI also has one exam that uses oral contrast to help visualize the digestive track. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. If excessive force is felt during stent deployment, do not force the delivery system. Remove the delivery system and replace with a new unit. 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 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. BD and the BD Logo are trademarks of Becton, Dickinson and Company. 2023 Boston Scientific Corporation or its affiliates. GMDN Names and Definitions: Copyright GMDN Agency 2015. Data on file. 617.638.8000. 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. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Testing completed by Boston Scientific Corporation. Find products, medical specialty information, and education opportunities. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Store in a cool, dark, dry place. EMERGE PTCA Dilatation Catheter. Data on File. The image is highly detailed and can show even the smallest abnormality. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 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. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. $ fG1012p("3| 2 MRI may not be recommended if for people who have a pacemaker or other metal implants. Bench test results may not necessarily be indicative of clinical performance.