Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. 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? BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. 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. Allergic/anaphylactic reaction; Amputation; Aneurysm; Arteriovenous fistula; Death related/unrelated to procedure; Dissection; Embolization; Extravasation; Fever; Hemorrhage/bleeding requiring a blood transfusion; Hematoma; Hypotension/hypertension; Incorrect positioning of the stent requiring further stenting or surgery; Intimal injury/dissection; Ischemia/infarction of tissue/organ; Local infection; Malposition (failure to deliver the stent to the intended site); Open surgical repair; Pain; Pulmonary embolism; Pseudoaneurysm; Renal failure; Respiratory arrest; Restenosis; Rupture; Septicemia/bacteremia; Stent Fracture; Stent Migration; Vasospasm; Venous occlusion/thrombosis/restenosis. 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. 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 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 ). Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan The Venovo Venous Stent System is supplied sterile and is intended for single use only. outflow obstruction. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Find out who we are, explore careers at the company, and view our financial performance. 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. 2023 Boston Scientific Corporation or its affiliates. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The image is highly detailed and can show even the smallest abnormality. 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. All rights reserved. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. AccessGUDID - DEVICE: Ascerta (08714729802976) 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. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. Missing x-ray analyses were recorded as protocol deviations. GMDN Names and Definitions: Copyright GMDN Agency 2015. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. MRI may not be recommended if for people who have a pacemaker or other metal implants. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Disposable devices intended to assist implantation may be included. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous The Freedom from TLR rate at 36 months was 88.1%. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Coronary artery spasm in the absence of a significant stenosis. All rights reserved. Find products, medical specialty information, and education opportunities. Do not resterilize and/or reuse the device. Available in sizes from 1.2 mm to 4.0 mm. for the treatment of iliofemoral venous occlusive disease. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange Bench test results may not necessarily be indicative of clinical performance. The compatibility of the device has not been evaluated for the delivery of materials (e.g. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. 0 hUmo0+}B~Dx&~XQT,%DN nU|w{p BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. Store in a cool, dark, dry place. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. Once the test has been completed people can return home and resume normal activities. Safe MR imaging involves a careful initial patient screening, accurate determination of the permanent implanted or temporary cardiovascular device and its properties, a thoughtful analysis of the risks and benefits of performing the examination at that time, and, when indicated, appropriate physician management and supervision. 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. $ fG1012p("3| 2 Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Bench tests may not be indicative of clinical performance. 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 device is intended for use by physicians who have received appropriate training. Different test methods may yield different results. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. %PDF-1.7 % Access our instructions for use and product manuals library. 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 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). Coils, Filters, Stents, and Grafts More. 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). PDF Summary of Safety and Effectivness (SSED)Template 617.638.8000. 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). Remove the delivery system and replace with a new unit. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. Recorded at the London Charing Cross Symposium in 2019. 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. For decades, we have worked together to define the future. All rights reserved. AccessGUDID - DEVICE: Ascerta Firm (08714729861720)
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