To assess the safety and effectiveness of the Venovo Venous Stent With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 0 Data on file. 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. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. This depends on the exam the doctor has ordered. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Access our instructions for use and product manuals library. MRI may not be recommended if for people who have a pacemaker or other metal implants. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. Staff also needs to know specific details about any implants in the body. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. MRI Information for Healthcare Professionals - Boston Scientific The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. through the guidewire lumen, other than those required for normal use. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. 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. NC EMERGE PTCA Dilatation Catheter - Boston Scientific 2023 BD. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. Stents were evaluated at the 36-month follow-up for fracture analysis. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. All rights reserved. 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. 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. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. 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. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. Do not exceed the balloon rated burst pressure. 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. 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 Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. 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. Testing completed by Boston Scientific Corporation. The average MRI exam takes about 45 minutes. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. Once the test has been completed people can return home and resume normal activities. Epub 2021 Sep 20. Bench tests may not be indicative of clinical performance. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . BD and the BD Logo are trademarks of Becton, Dickinson and Company. 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. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 $ fG1012p("3| 2 We host and take part in events that excel in advancing the world of health. ;;>BFZQC. MRI also has one exam that uses oral contrast to help visualize the digestive track. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. 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. 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. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Reproduced with Permission from the GMDN Agency. AccessGUDID - DEVICE: Ascerta (08714729802976) Data on file. Find out who we are, explore careers at the company, and view our financial performance. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. If excessive force is felt during stent deployment, do not force the delivery system. 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. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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. One Boston Medical Center Place for the treatment of iliofemoral venous occlusive disease. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. Do not use the device after the Use By date specified on the label. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The image is highly detailed and can show even the smallest abnormality. The Venovo Venous Stent System is supplied sterile and is intended for single use only. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. 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 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. 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. This site is Exclusively Sponsored by BRACCO. Note: Boston Scientific Corporation is not responsible for correct use of codes on . 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. We are committed to providing the best experience possible for our patients and visitors. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Data on file. Data on file. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. A sales representive will get in touch with you shortly. CAUTION: The law restricts these devices to sale by or on the order of a physician. All rights reserved. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. AccessGUDID - DEVICE: Tria Soft (08714729959915) The delivery system is not designed for use with power injection systems. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Bench test results may not necessarily be indicative of clinical performance. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Wallstent EndoprosthesisMagic Wallstent3.5 x 25coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Wallstent EndoprosthesisWith Permalume covering8 x 80coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Wallstent Esophageal II Endoprosthesis20 x 130coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, WALLSTENT RX Biliary EndoprosthesisBoston Scientifichttp://www.bostonscientific.com, WALLSTENT Venous, Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com, WallStentcarotid artery stentBoston Scientific CorporationMaple Grove, MN, Wallstentplatinum and cobalt-alloycoil, stent, filterSchneiderBulach, Switzerland, Walvekar Salivary Duct StentHood Laboratories, www.hoodlabs.com, Watchman Gen 4 ImplantAtritech Inc. and Boston Scientific, www.bostonscientific.com, Watchman Left Atrial Appendage Closure DeviceAtritech Inc. and Boston Scientific, www.bostonscientific.com, WEB Aneurysm Embolization Device Sequent Medical, Inc./Microvention, www.microvention.com, Weck Horizon, Titanium Clip, All sizes Teleflex Medical, www.teleflex.com, WedgeLoc Suture Anchor with Opti-Fiber SuturesMedShape SolutionsAtlanta, GA, WedgeLoc Suture AnchorMedShape Solutions, Inc.Atlanta, GA, Wehrs Incus Prosthesis, Otologic ImplantGyrus ACMI, www.gyrusacmi.com, WessexAortic, Model WAV10heart valveSorin BiomedicaItaly, WessexMitral, Model WMV20heart valveSorin BiomedicaItaly, Westaby T-Y StentHood Laboratories, www.hoodlabs.com, Western EZ-OX Plus SystemALQ-2342 on an Aluminum D cylinderWestern EnterprisesWestlake, OH. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. 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. 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. Data on file. 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. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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). 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. Dake, Michael D, et al. 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 balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. 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). The device is typically intended for long-term, but not permanent, implantation. Do not resterilize and/or reuse the device. Bench test results may not necessarily be indicative of clinical performance. The safety and effectiveness of this device for use in the arterial system have not been established. Coils, Filters, Stents, and Grafts More. 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. All rights reserved. endstream endobj 2789 0 obj <>stream The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Patients having an enterography, may be at BMC up to 3 hours. Do not expand the balloon if it is not properly positioned in the vessel. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. THE List - MRI Safety 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. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide 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. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 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. Coronary artery spasm in the absence of a significant stenosis. 2=[DE8m|E23 jIrL|bW30+;$12r+e5Jl+]pVIn[Ndck0xc$VVq+9e'0")m275ahsk8/` $4,,:8X3@$3h` u40y@p ` i;+:dXf`6@,ohH=`)35^7;7>n`pRwg 1hQb`br&Y' 6G hUmo0+}B~Dx&~XQT,%DN nU|w{p MR Safety and Imaging of Neuroform Stents at 3T Directions for Use. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 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.
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