Coils, Filters, Stents, and Grafts More. 44, no. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). 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. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. 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. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 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. Kaplan-Meier Primary Patency in Post-Thrombotic Lesions at 36 months, Kaplan-Meier Primary Patency in Non-Thrombotic Lesions at 36 months, Freedom from Target Lesion Revascularization (TLR) at 36 months. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Find products, medical specialty information, and education opportunities. 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 The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. All other trademarks are the property of their respective owners. Then the patient is brought out of the scanner. Coils, Filters, Stents, and Grafts More. Find products, medical specialty information, and education opportunities. Different test methods may yield different results. 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. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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 Once the scan is complete, the technologist will review the images to make sure all the information needed is there. 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. %%EOF Note: Boston Scientific Corporation is not responsible for correct use of codes on . Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Find out who we are, explore careers at the company, and view our financial performance. 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. Boston, MA 02118 Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. The device is typically intended for long-term, but not permanent, implantation. 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. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Stents were evaluated at the 36-month follow-up for fracture analysis. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Do not use the device with contralateral access. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Never use air or any gaseous medium to inflate the balloon. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Do not attempt to break, damage, or disrupt the stent after placement. The Venovo Venous Stent System is supplied sterile and is intended for single use only. 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. 2805 0 obj <>stream Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Find out who we are, explore careers at the company, and view our financial performance. MRI exams require people to lie still for the entire length of the study. 3Foreshortening is calculated as the difference, represented as percentage, between the compressed stent length and expanded stent length at minimum/maximum oversize (1-3 mm). 1.5,3: Safe More. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Store in a cool, dark, dry place. During system flushing, observe that saline exits at the catheter tip. 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. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. 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. 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. Find products, medical specialty information, and education opportunities. Epub 2021 Sep 20. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. 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. 2023 Boston Scientific Corporation or its affiliates. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. The Freedom from TLR rate at 36 months was 88.1%. All rights reserved. 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. 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. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. Data on file, BD Peripheral Intervention, Tempe, AZ. 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. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. 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 . Staff also needs to know specific details about any implants in the body. GMDN Names and Definitions: Copyright GMDN Agency 2015. outflow obstruction. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. 2785 0 obj <> endobj Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. One Boston Medical Center Place 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. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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. Use only the recommended balloon inflation medium. Do not expose the delivery system to organic solvents, e.g., alcohol. 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. 2023 Boston Medical Center. 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 delivery system is not designed for use with power injection systems. To assess the safety and effectiveness of the Venovo Venous Stent 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 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 hUmo0+}B~Dx&~XQT,%DN nU|w{p Missing x-ray analyses were recorded as protocol deviations. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. $ fG1012p("3| 2 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. Bench test results may not necessarily be indicative of clinical performance. Access our instructions for use and product manuals library. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. 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. 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. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. 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. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. through the guidewire lumen, other than those required for normal use. All rights reserved. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. Find out who we are, explore careers at the company, and view our financial performance. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. Disposable devices intended to assist implantation may be included. Data on file. All rights reserved. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. To obtain copies images, please call the film library at 617.414.5882. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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).