The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). MR Safety and Imaging of Neuroform Stents at 3T 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. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) A sales representive will get in touch with you shortly. Do not use the device after the Use By date specified on the label. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. Patients having an enterography, may be at BMC up to 3 hours. Most people are able to complete the exam easily, but for those who are uncomfortable, there are staff trained to assist them in completing the exam through relaxation and visualization techniques. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). through the guidewire lumen, other than those required for normal use. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 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. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Data on file. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. Boston Scientific Announces Results for First Quarter 2023 All rights reserved. for the treatment of iliofemoral venous occlusive disease. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. 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. AccessGUDID - DEVICE: Ascerta (08714729802976) Note: Boston Scientific Corporation is not responsible for correct use of codes on . This depends on the exam the doctor has ordered. All rights reserved. 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 Data on file, BD Peripheral Intervention, Tempe, AZ. The compatibility of the device has not been evaluated for the delivery of materials (e.g. Data on file. 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 One Boston Medical Center Place Then the patient is brought out of the scanner. 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 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. PDF Summary of Safety and Effectivness (SSED)Template 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. 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. 44, no. hUmo0+}B~Dx&~XQT,%DN nU|w{p EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Directions for Use. 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. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. AccessGUDID - DEVICE: Tria Soft (08714729959915) 2023 Boston Medical Center. NC EMERGE PTCA Dilatation Catheter - Boston Scientific C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Different test methods may yield different results. 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 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. 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. For decades, we have worked together to define the future. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Never use air or any gaseous medium to inflate the balloon. 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 ). Do not use the device with contralateral access. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. %%EOF endstream endobj 2789 0 obj <>stream Bench test results may not necessarily be indicative of clinical performance. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 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. 1.5 . 0 Bench tests may not be indicative of clinical performance. To obtain copies images, please call the film library at 617.414.5882. Boston Scientific, www.bostonscientific.com . ;;>BFZQC. 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". 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. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). All other trademarks are the property of their respective owners. The SYNERGY. 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. Find out who we are, explore careers at the company, and view our financial performance. All rights reserved. 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. Data on File. Coronary artery spasm in the absence of a significant stenosis. 2805 0 obj <>stream At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. 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. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. 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 List - MRI Safety Data on file. 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. All rights reserved. Reproduced with Permission from the GMDN Agency. THE List - MRI Safety Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. hbbd```b``>"tH/ 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. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Data on file. Find out who we are, explore careers at the company, and view our financial performance. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. 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. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. 2023 Boston Scientific Corporation or its affiliates. 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). GMDN Names and Definitions: Copyright GMDN Agency 2015. Safety of Magnetic Resonance Imaging in Patients With - Circulation BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Fortunately, the devices that exhibited po . The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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 SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. EMERGE PTCA Dilatation Catheter. The stent is not designed for repositioning or recapturing. 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. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). 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. 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 Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Disposable devices intended to assist implantation may be included. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. The safety and effectiveness of this device for use in the arterial system have not been established. 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. Do not exceed the balloon rated burst pressure. Recorded at the London Charing Cross Symposium in 2019. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. All rights reserved. outflow obstruction. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. 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. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Disposable devices intended to assist implantation may be included. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam.
