A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. Several of these demonstrated magnetic field interactions. 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. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. MR Safety and Imaging of Neuroform Stents at 3T Safety of Magnetic Resonance Imaging in Patients With - Circulation We host and take part in events that excel in advancing the world of health. Coronary artery spasm in the absence of a significant stenosis. Remove the delivery system and replace with a new unit. To assess the safety and effectiveness of the Venovo Venous Stent Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Venovo Venous Stent System - BD If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). 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. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. 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 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. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. Bench test results may not necessarily be indicative of clinical performance. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. The ordering physician will go over the findings with their patient. 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. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). %PDF-1.7 % Find products, medical specialty information, and education opportunities. THE List - MRI Safety 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. Choose from Monorail and Over-the-Wire Catheter options. 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. Find out who we are, explore careers at the company, and view our financial performance. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Find products, medical specialty information, and education opportunities. 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. 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. endstream endobj startxref Boston Scientific Announces Results for First Quarter 2023 With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. 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. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. 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 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. Bench tests may not be indicative of clinical performance. 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. endstream endobj 2789 0 obj <>stream 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. All rights reserved. Several of these demonstrated magnetic field interactions. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. All rights reserved. Find out who we are, explore careers at the company, and view our financial performance. All other trademarks are the property of their respective owners. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. 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. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. AccessGUDID - DEVICE: Tria Soft (08714729959915) Reproduced with Permission from the GMDN Agency. 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). This site is Exclusively Sponsored by BRACCO. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. BD and the BD Logo are trademarks of Becton, Dickinson and Company. Fortunately, the devices that exhibited po . Dake, Michael D, et al. The compatibility of the device has not been evaluated for the delivery of materials (e.g. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. Missing x-ray analyses were recorded as protocol deviations. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. Stents were evaluated at the 36-month follow-up for fracture analysis. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. 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. Find products, medical specialty information, and education opportunities. 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. 1.5 . Receive Updates. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. All rights reserved. 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. Data on file. PDF Summary of Safety and Effectivness (SSED)Template $ fG1012p("3| 2 hUmo0+}B~Dx&~XQT,%DN nU|w{p The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Premarket Submission Number Not Available/Not Released. Data on file. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. alcohol or nitroglycerine, stem cells, etc.) AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. 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. MRI Information for Healthcare Professionals - Boston Scientific An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. 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 If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). 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 C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Disposable devices intended to assist implantation may be included. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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 Never use air or any gaseous medium to inflate the balloon. 1.5, 3: Conditional 5 More. Access our instructions for use and product manuals library. If excessive force is felt during stent deployment, do not force the delivery system. Testing completed by Boston Scientific Corporation. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. 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). Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 2023 Boston Scientific Corporation or its affiliates. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. The Freedom from TLR rate at 36 months was 88.1%. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. for the treatment of iliofemoral venous occlusive disease. Data on file. outflow obstruction. 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 At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. Data on File. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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. 1.5,3: Safe More. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. A sales representive will get in touch with you shortly. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Coils, Filters, Stents, and Grafts More. 2023 Boston Scientific Corporation or its affiliates. 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. hbbd```b``>"tH/ 617.638.8000. MRI also has one exam that uses oral contrast to help visualize the digestive track. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Note: Boston Scientific Corporation is not responsible for correct use of codes on . 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 ). Store in a cool, dark, dry place. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Directions for Use. This depends on the exam the doctor has ordered. EMERGE PTCA Dilatation Catheter. 2023 BD. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The stent is not designed for repositioning or recapturing. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. 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. 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. The device is typically intended for long-term, but not permanent, implantation. BMC physicians are leaders in their fields with the most advanced medical technology at their fingertips and working alongside a highly skilled nursing and professional staff. o. 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. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. NC EMERGE PTCA Dilatation Catheter - Boston Scientific
Why Is My Eucalyptus Plant Leaves Turning Brown, Articles B