Find out who we are, explore careers at the company, and view our financial performance. Fortunately, the devices that exhibited po . 1.5 . 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. 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. 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 SYNERGY. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Bench test results may not necessarily be indicative of clinical performance. Use only the recommended balloon inflation medium. To assess the safety and effectiveness of the Venovo Venous Stent Different test methods may yield different results. 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). Data on file. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Find out who we are, explore careers at the company, and view our financial performance. 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. MRI may not be recommended if for people who have a pacemaker or other metal implants. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. Do not resterilize and/or reuse the device. 2023 Boston Medical Center. 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. Recorded at the London Charing Cross Symposium in 2019. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. MRI also has one exam that uses oral contrast to help visualize the digestive track. The delivery system is not designed for use with power injection systems. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). All rights reserved. Several of these demonstrated magnetic field interactions. 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. 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. %%EOF 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 ). Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. For decades, we have worked together to define the future. 2023 Boston Scientific Corporation or its affiliates. through the guidewire lumen, other than those required for normal use. Bench tests may not be indicative of clinical performance. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. alcohol or nitroglycerine, stem cells, etc.) Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. Do not expand the balloon if it is not properly positioned in the vessel. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. 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 If difficulty is experienced during balloon inflation, do not continue; remove the catheter. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). This depends on the exam the doctor has ordered. 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 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. The average MRI exam takes about 45 minutes. 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. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Premarket Submission Number Not Available/Not Released. During system flushing, observe that saline exits at the catheter tip. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q 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. Find products, medical specialty information, and education opportunities. hUmo0+}B~Dx&~XQT,%DN nU|w{p C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 1.5,3: Safe More. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 44, no. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ;;>BFZQC. Do not attempt to break, damage, or disrupt the stent after placement. 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. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. Then the patient is brought out of the scanner. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. 2805 0 obj <>stream 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. The safety and effectiveness of this device for use in the arterial system have not been established. %PDF-1.7 % 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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 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 We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Boston, MA 02118 Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. All other trademarks are the property of their respective owners. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. The compatibility of the device has not been evaluated for the delivery of materials (e.g. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Never use air or any gaseous medium to inflate the balloon. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. The device is typically intended for long-term, but not permanent, implantation. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Staff also needs to know specific details about any implants in the body. o. 98 subjects x-rays were analyzed and no stent fractures were reported. Data on file. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Coronary artery spasm in the absence of a significant stenosis. 2023 Boston Scientific Corporation or its affiliates. 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. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. All rights reserved. Dake, Michael D, et al. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The image is highly detailed and can show even the smallest abnormality. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . The device is typically intended for long-term, but not permanent, implantation. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Data on file. Data on file. GMDN Names and Definitions: Copyright GMDN Agency 2015. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. The stent is not designed for repositioning or recapturing. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. EMERGE PTCA Dilatation Catheter. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . hbbd```b``>"tH/ BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Do not expose the delivery system to organic solvents, e.g., alcohol. Dr. Michael Dake, Senior VP for Health Sciences at the University of Arizona and Principal Investigator in the VenovoVenous Stent VERNACULAR trial shares key findings from the 24-month clinical results including primary patency rates, target lesion revascularization (TLR) and fracture rates, patient quality of life, and more. 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. 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). If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan 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? Bench test results may not necessarily be indicative of clinical performance. Data on file, BD Peripheral Intervention, Tempe, AZ. GMDN Names and Definitions: Copyright GMDN Agency 2015. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Find products, medical specialty information, and education opportunities. 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. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Choose from Monorail and Over-the-Wire Catheter options. Do not use if pouch is opened or damaged. 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Find out who we are, explore careers at the company, and view our financial performance. 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 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Testing completed by Boston Scientific Corporation. 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.
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