boston scientific emerge stent mri safety boston scientific emerge stent mri safety
This depends on the exam the doctor has ordered. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. 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. 1.5,3: Safe More. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. 2023 Boston Medical Center. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Data on file. Do not resterilize and/or reuse the device. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . Dake, Michael D, et al. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Different test methods may yield different results. 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. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). BD and the BD Logo are trademarks of Becton, Dickinson and Company. Stents were evaluated at the 36-month follow-up for fracture analysis. endstream endobj startxref Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Dr. Michael Dake, Senior VP for Health Sciences at the University of Arizona and Principal Investigator in the VenovoVenous Stent VERNACULAR trial shares key findings from the 24-month clinical results including primary patency rates, target lesion revascularization (TLR) and fracture rates, patient quality of life, and more. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 2023 Boston Scientific Corporation or its affiliates. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Then the patient is brought out of the scanner. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. 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 ). Data on file. 44, no. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Find out who we are, explore careers at the company, and view our financial performance. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Directions for Use. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. 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. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. alcohol or nitroglycerine, stem cells, etc.) Find out who we are, explore careers at the company, and view our financial performance. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. All stents should be deployed in accordance with the manufacturers indications and instructions for use. 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. MRI also has one exam that uses oral contrast to help visualize the digestive track. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. 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 residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. 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. The SYNERGY. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 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. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Store in a cool, dark, dry place. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. 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. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. The stent is not designed for repositioning or recapturing. 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. Boston, MA 02118 The C-Code used for 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. 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. through the guidewire lumen, other than those required for normal use. 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. 850 W Rio Salado Pkwy, Tempe, AZ 85281 United States, 6:00 a.m. 4:30 p.m. Arizona Time (Monday-Friday), Surgical Instruments and Sterilization Container products. The Venovo Venous Stent System is contraindicated for use in patients with a known hypersensitivity to nitinol (nickel-titanium) and tantalum, who cannot receive intraprocedural anti-coagulation therapy, or who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system. The device is typically intended for long-term, but not permanent, implantation. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. Data on file, BD Peripheral Intervention, Tempe, AZ. The compatibility of the device has not been evaluated for the delivery of materials (e.g. 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Disposable devices intended to assist implantation may be included. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Disposable devices intended to assist implantation may be included. Premarket Submission Number Not Available/Not Released. 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 other trademarks are the property of their respective owners. The safety and effectiveness of this device for use in the arterial system have not been established. 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 Coils, Filters, Stents, and Grafts More. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Data on file. Polaris Ultra Ureteral Stent EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. All rights reserved. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. Missing x-ray analyses were recorded as protocol deviations. Recorded at the London Charing Cross Symposium in 2019. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. for the treatment of iliofemoral venous occlusive disease. All rights reserved. 2023 Boston Scientific Corporation or its affiliates. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. 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. 2785 0 obj <> endobj outflow obstruction. 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. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. Data on File. Remove the delivery system and replace with a new unit. Results shown as averages measured in N/mm as follows (n=6): Venovo Venous Stent System (0.126), Medtronic Abre Venous Stent (0.1035), Cook Zilver Vena (0.063) and Boston Scientific VICI VENOUS STENT (0.054). 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. 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. 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. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. All rights reserved. 0 Find products, medical specialty information, and education opportunities. Reproduced with Permission from the GMDN Agency. 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". Bench test results may not necessarily be indicative of clinical performance. 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 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. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Do not use the device after the Use By date specified on the label. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Data on file. Do not use the device with contralateral access. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. 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. All rights reserved. Choose from Monorail and Over-the-Wire Catheter options. For decades, we have worked together to define the future. ZGlide hydrophilic coating reduces frictional force on the catheter shaft by 51% in bench tests, Unique, over-the-inner tip design: outer tip material rides over the inner shaft material and is designed to improve overall flexibility and tip performance, Profiles: Ultra-low 0.017 tip profile and 0.026 crossing profile, Balloon Material: OptiLEAP balloon material provides sizing flexibility, Platinum marker bands provide optimal radiopacity. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 1.5 . Coronary artery spasm in the absence of a significant stenosis. 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. Fortunately, the devices that exhibited po . A sales representive will get in touch with you shortly. 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. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan The delivery system is not designed for use with power injection systems. 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. MRI may not be recommended if for people who have a pacemaker or other metal implants. 617.638.8000. 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. Bench test results may not necessarily be indicative of clinical performance. If excessive force is felt during stent deployment, do not force the delivery system. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. $ fG1012p("3| 2 SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Data on file. The average MRI exam takes about 45 minutes. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 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. Never use air or any gaseous medium to inflate the balloon. 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. We host and take part in events that excel in advancing the world of health. 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. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Coils, Filters, Stents, and Grafts More. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. 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 Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . Do not exceed the balloon rated burst pressure. 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). Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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). MRI exams require people to lie still for the entire length of the study. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. Receive Updates. Testing completed by Boston Scientific Corporation. Reproduced with Permission from the GMDN Agency. 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. GMDN Names and Definitions: Copyright GMDN Agency 2015. To obtain copies images, please call the film library at 617.414.5882. Epub 2021 Sep 20. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 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.
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