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. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. 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. All rights reserved. Never use air or any gaseous medium to inflate the balloon. GMDN Names and Definitions: Copyright GMDN Agency 2015. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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 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. 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. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. 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 difficulty is experienced during balloon inflation, do not continue; remove the catheter. Do not exceed the balloon rated burst pressure. 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. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The delivery system is not designed for use with power injection systems. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Data on file. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Data on file. Stents were evaluated at the 36-month follow-up for fracture analysis. 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). Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. The SYNERGY. Do not use if pouch is opened or damaged. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Find products, medical specialty information, and education opportunities. 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. The Freedom from TLR rate at 36 months was 88.1%. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. 1.5, 3: Conditional 5 More. MRI Information for Healthcare Professionals - Boston Scientific All stents should be deployed in accordance with the manufacturers indications and instructions for use. %PDF-1.7 % The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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. One Boston Medical Center Place Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. 2023 Boston Scientific Corporation or its affiliates. 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. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Epub 2021 Sep 20. Boston Scientific, www.bostonscientific.com . THE List - MRI Safety All rights reserved. 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. Bench test results may not necessarily be indicative of clinical performance. 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 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 resterilize and/or reuse the device. 44, no. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. The compatibility of the device has not been evaluated for the delivery of materials (e.g. Boston Scientific Announces Results for First Quarter 2023 98 subjects x-rays were analyzed and no stent fractures were reported. 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. Data on file. Shellock R & D Services, Inc. email: [email protected]. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . Choose from Monorail and Over-the-Wire Catheter options. Find out who we are, explore careers at the company, and view our financial performance. PMA Applicant: Boston Scientific Corporation Address: One Scimed Place, Maple Grove, MN 55311-1566 Approval Date: August 11, 2020 Approval Letter: Approval Order What is it? Coronary artery spasm in the absence of a significant stenosis. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. hUmo0+}B~Dx&~XQT,%DN nU|w{p All rights reserved. Shellock R & D Services, Inc. email: [email protected]. The ordering physician will go over the findings with their patient. hbbd```b``>"tH/ This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. BD and the BD Logo are trademarks of Becton, Dickinson and Company. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. Dake, Michael D, et al. Coils, Filters, Stents, and Grafts More. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). 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 a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous 0 Remove the delivery system and replace with a new unit. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) 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 AccessGUDID - DEVICE: Ascerta (08714729802976) 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 The device is typically intended for long-term, but not permanent, implantation. The safety and effectiveness of this device for use in the arterial system have not been established. Directions for Use. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information The average MRI exam takes about 45 minutes. Find products, medical specialty information, and education opportunities. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. 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. Data on file. 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, EMERGE PTCA Dilatation Catheter - Boston Scientific, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Exceptional deliverability and low profiles designed to cross tight lesions, High rated burst pressure 18 ATM (1824 kPa) for sizing flexibility, Two shaft designs provide options for challenging lesions, EMERGE Catheter is designed for exceptional simultaneous use performance, Shaft profile allows for simultaneous use of two Monorail catheters in a 6 F guide catheter and two Over-the-Wire catheters in an 8 F guide catheter*, Designed to optimize stent apposition in large, proximal vessels, Two shaft options with distinct technologies designed to provide flexibility for navigating to and through even the most challenging lesions, Push technology: Single-segment inner shaft design for ultimate pushability 1.2 mm and 1.5 mm Push, Workhorse technology: Bi-Segment inner shaft designed for maximum deliverability without sacrificing pushability (1.2 mm to 4.0 mm). through the guidewire lumen, other than those required for normal use. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. EMERGE PTCA Dilatation Catheter. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. 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. 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. endstream endobj startxref Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. Use only the recommended balloon inflation medium. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Find products, medical specialty information, and education opportunities. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Patients having an enterography, may be at BMC up to 3 hours. 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. Premarket Submission Number Not Available/Not Released. If excessive force is felt during stent deployment, do not force the delivery system. 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. Coils, Filters, Stents, and Grafts More. ** 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. 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. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. 2023 Boston Medical Center. 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. 2805 0 obj <>stream Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. 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). Disposable devices intended to assist implantation may be included. All rights reserved. Missing x-ray analyses were recorded as protocol deviations. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange All other trademarks are the property of their respective owners. $ fG1012p("3| 2 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. 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. All rights reserved. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 2785 0 obj <> endobj 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Data on file. Testing completed by Boston Scientific Corporation. Do not use the device after the Use By date specified on the label. Find products, medical specialty information, and education opportunities. Available in sizes from 1.2 mm to 4.0 mm. We are committed to providing the best experience possible for our patients and visitors. 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. Data on file. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. EMERGE PTCA Dilatation Catheter - Boston Scientific The image is highly detailed and can show even the smallest abnormality. Disposable devices intended to assist implantation may be included. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. NC EMERGE PTCA Dilatation Catheter - Boston Scientific A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. Access our instructions for use and product manuals library. Data on file. o. Do not use the device with contralateral access. 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.
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