AccessGUDID - DEVICE: Ascerta (08714729802976) Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Data on file. Patients having an enterography, may be at BMC up to 3 hours. To obtain copies images, please call the film library at 617.414.5882. One Boston Medical Center Place NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. The device is typically intended for long-term, but not permanent, implantation. During system flushing, observe that saline exits at the catheter tip. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Premarket Submission Number Not Available/Not Released. MRI Information for Healthcare Professionals - Boston Scientific 0 Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. NC EMERGE PTCA Dilatation Catheter - Boston Scientific Reproduced with Permission from the GMDN Agency. Bench tests may not be indicative of clinical performance. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 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. 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. 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). Data on file. MRI exams require people to lie still for the entire length of the study. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Then the patient is brought out of the scanner. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP 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 stents should be deployed in accordance with the manufacturers indications and instructions for use. Available in sizes from 1.2 mm to 4.0 mm. 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. MR Safety and Imaging of Neuroform Stents at 3T On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. 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 Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. BD and the BD Logo are trademarks of Becton, Dickinson and Company. The SYNERGY. 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 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. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . 2023 Boston Medical Center. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Safety of Magnetic Resonance Imaging in Patients With - Circulation Find products, medical specialty information, and education opportunities. Find out who we are, explore careers at the company, and view our financial performance. Magnetic Resonance Imaging (MRI) | Boston Medical Center Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 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. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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". 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. 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. 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. 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. The Freedom from TLR rate at 36 months was 88.1%. endstream endobj startxref Several of these demonstrated magnetic field interactions. Data on File. The Venovo Venous Stent System is supplied sterile and is intended for single use only. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. o. 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. MARLBOROUGH, Mass., April 26, 2023 / PRNewswire / -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational 1 basis and 14.0 percent on an organic 2 basis, all compared to the prior year period. Do not attempt to break, damage, or disrupt the stent after placement. A patient with the VICI VENOUS STENT can be scanned safely, immediately after placement, in an MR system meeting the following conditions: o Static magnetic field of 1.5 T or 3.0 T only. Polaris Ultra Ureteral Stent Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. 1 The Venovo Venous Stent System was studied in the global VERNACULAR clinical trial, which was a prospective, multi-center, non-randomized, single-arm study of 170 patients. 2805 0 obj <>stream Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Data on file. The NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters (balloon models 2.00- 5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). hbbd```b``>"tH/ U~ S?)DO(X`dpHpEjq[p10Lv1 Hjer8(,mArFFzMfzSdZn8,=}SGp=!x2|6eCjoVJfPb*K=]Q b?s/=2>I*6yeO-+7Xb{C/^9)#/> # Tu[sS*[eWc!Z9PEPW-OG#*vQJ*U' lK(^>EZoCq8VlS6>s$i \s#zG=?O4E Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. 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. hUmo0+}B~Dx&~XQT,%DN nU|w{p EMERGE PTCA Dilatation Catheter. 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 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 compatibility of the device has not been evaluated for the delivery of materials (e.g. All rights reserved. Missing x-ray analyses were recorded as protocol deviations. 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. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Bench test results may not necessarily be indicative of clinical performance. THE List - MRI Safety All rights reserved. Do not use the device after the Use By date specified on the label. AccessGUDID - DEVICE: Tria Soft (08714729959915) The device is typically intended for long-term, but not permanent, implantation. Access our instructions for use and product manuals library. 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. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 2023 Boston Scientific Corporation or its affiliates. Fortunately, the devices that exhibited po . C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 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. Coronary artery spasm in the absence of a significant stenosis. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. All rights reserved. Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q All rights reserved. Disposable devices intended to assist implantation may be included. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Recorded at the London Charing Cross Symposium in 2019. The average MRI exam takes about 45 minutes. Stents were evaluated at the 36-month follow-up for fracture analysis. 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. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 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. 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. Dake, Michael D, et al. 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. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death.
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