Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. The Venovo Venous Stent System is supplied sterile and is intended for single use only. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. 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. The delivery system is not designed for use with power injection systems. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. o. Do not use the device after the Use By date specified on the label. 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Data on File. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Recorded at the London Charing Cross Symposium in 2019. For decades, we have worked together to define the future. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. MRI exams require people to lie still for the entire length of the study. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Dake, Michael D, et al. The ordering physician will go over the findings with their patient. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Testing completed by Boston Scientific Corporation. 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. Bench test results may not necessarily be indicative of clinical performance. During system flushing, observe that saline exits at the catheter tip. THE List - MRI Safety Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. The device is typically intended for long-term, but not permanent, implantation. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. Find products, medical specialty information, and education opportunities. The compatibility of the device has not been evaluated for the delivery of materials (e.g. Staff also needs to know specific details about any implants in the body. Coronary artery spasm in the absence of a significant stenosis. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. All other trademarks are the property of their respective owners. 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 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. 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. Store in a cool, dark, dry place. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Prior to stent deployment, remove slack from the delivery system catheter outside the patient. hbbd```b``>"tH/ Once the scan is complete, the technologist will review the images to make sure all the information needed is there. 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. 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. Different test methods may yield different results. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. 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). A sales representive will get in touch with you shortly. Several of these demonstrated magnetic field interactions. Remove the delivery system and replace with a new unit. 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). Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 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. 98 subjects x-rays were analyzed and no stent fractures were reported. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Then the patient is brought out of the scanner. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. THE List - MRI Safety If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 1.5, 3: Conditional 5 More. To obtain copies images, please call the film library at 617.414.5882. 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. A Deeper Dive into the Venovo Venous Stent System, PRESS RELEASE - MAR 14, 2019, PR NEWSWIRE, BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease, One-year data from venous stent registry "promising". BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. All rights reserved. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. 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). Data on file, BD Peripheral Intervention, Tempe, AZ. Disposable devices intended to assist implantation may be included. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. hUmo0+}B~Dx&~XQT,%DN nU|w{p The SYNERGY. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . 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. Directions for Use. Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com.