Fortunately, the devices that exhibited po . An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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. All rights reserved. A sales representive will get in touch with you shortly. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 2023 Boston Medical Center. The NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. Dake, Michael D, et al. 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Do not expand the balloon if it is not properly positioned in the vessel. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All other trademarks are the property of their respective owners. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. MRI exams require people to lie still for the entire length of the study. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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. 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 Data on file. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Bench test results may not necessarily be indicative of clinical performance. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. 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. 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. 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. Disposable devices intended to assist implantation may be included. Data on file. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. Do not attempt to break, damage, or disrupt the stent after placement. Find products, medical specialty information, and education opportunities. CAUTION: The law restricts these devices to sale by or on the order of a physician. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Data on file. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Remove the delivery system and replace with a new unit. BD and the BD Logo are trademarks of Becton, Dickinson and Company. 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. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. 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. 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 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. Coils, Filters, Stents, and Grafts More. Dr. Gerard O'Sullivan, FSIR, FEBIR of Galway University Hospitals in Galway, Ireland and Dr. Steven Dubenec, MBBS, FRACS, Head of Vascular Surgery at the Royal Prince Alfred Hospital in Sydney, Australia discuss important features of the VenovoVenous Stent and their personal experiences using the product. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. All rights reserved. The safety and effectiveness of this device for use in the arterial system have not been established. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 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 On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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). BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. To assess the safety and effectiveness of the Venovo Venous Stent 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. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. 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. Reusing this medical device bears the risk of cross-patient contamination as medical devices particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. 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. 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. Bench tests may not be indicative of clinical performance. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. THE List - MRI Safety MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. Testing completed by Boston Scientific Corporation. We are committed to providing the best experience possible for our patients and visitors. Several of these demonstrated magnetic field interactions. 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 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Find out who we are, explore careers at the company, and view our financial performance. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. Testing completed by Boston Scientific Corporation. 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. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. The device is typically intended for long-term, but not permanent, implantation. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. Data on File. All other trademarks are the property of their respective owners. PDF Summary of Safety and Effectivness (SSED)Template 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. 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific 2805 0 obj <>stream %PDF-1.7 % *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 GMDN Names and Definitions: Copyright GMDN Agency 2015. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All rights reserved. All rights reserved. endstream endobj 2789 0 obj <>stream If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. 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. 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 617.638.8000. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Epub 2021 Sep 20. Boston Scientific Announces Results for First Quarter 2023 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 radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. outflow obstruction. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Find products, medical specialty information, and education opportunities. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! Shellock R & D Services, Inc. email: [email protected]. 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. 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. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. One Boston Medical Center Place For decades, we have worked together to define the future. Coils, Filters, Stents, and Grafts More. Magnetic Resonance Imaging (MRI) | Boston Medical Center If difficulty is experienced during balloon inflation, do not continue; remove the catheter. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. Find out who we are, explore careers at the company, and view our financial performance. 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. Safety of Magnetic Resonance Imaging in Patients With - Circulation 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. The image is highly detailed and can show even the smallest abnormality. 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. Access our instructions for use and product manuals library. The compatibility of the device has not been evaluated for the delivery of materials (e.g. 2023 Boston Scientific Corporation or its affiliates. Several of these demonstrated magnetic field interactions. 2023 Boston Scientific Corporation or its affiliates. Store in a cool, dark, dry place. Stents were evaluated at the 36-month follow-up for fracture analysis. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. The ordering physician will go over the findings with their patient. 2023 BD. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 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. Do not use if pouch is opened or damaged. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. If excessive force is felt during stent deployment, do not force the delivery system. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . 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. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. 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 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. 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. Use only the recommended balloon inflation medium. During system flushing, observe that saline exits at the catheter tip. Shellock R & D Services, Inc. email: [email protected]. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. 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. NC EMERGE PTCA Dilatation Catheter - Boston Scientific 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". Different test methods may yield different results. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. MARLBOROUGH, Mass., April 26, 2023 / PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational 1 basis and 14.0 percent on an organic 2 basis, all compared to the prior year period. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. 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. The SYNERGY. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Never use air or any gaseous medium to inflate the balloon. 2023 Boston Scientific Corporation or its affiliates. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. 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.