boston scientific emerge stent mri safety

This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. This depends on the exam the doctor has ordered. All other trademarks are the property of their respective owners. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. EMERGE PTCA Dilatation Catheter - Boston Scientific Several of these demonstrated magnetic field interactions. AccessGUDID - DEVICE: Tria Soft (08714729959915) 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. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Epub 2021 Sep 20. 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. 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 Choose from Monorail and Over-the-Wire Catheter options. Reproduced with Permission from the GMDN Agency. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Data on file, BD Peripheral Intervention, Tempe, AZ. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Access our instructions for use and product manuals library. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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. Find products, medical specialty information, and education opportunities. Bench test results may not necessarily be indicative of clinical performance. Data on file. Boston Scientific, www.bostonscientific.com . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. 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. Directions for Use. Note: Boston Scientific Corporation is not responsible for correct use of codes on . 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). Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide 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 average MRI exam takes about 45 minutes. 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. ;;>BFZQC. Dake, Michael D, et al. If excessive force is felt during stent deployment, do not force the delivery system. 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 Do not use the device after the Use By date specified on the label. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Do not resterilize and/or reuse the device. 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. Reproduced with Permission from the GMDN Agency. Then the patient is brought out of the scanner. Find out who we are, explore careers at the company, and view our financial performance. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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. Recorded at the London Charing Cross Symposium in 2019. Data on file. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. Stents were evaluated at the 36-month follow-up for fracture analysis. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. $ fG1012p("3| 2 Data on File. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 1.5 . 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. 2023 Boston Medical Center. TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. 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 We host and take part in events that excel in advancing the world of health. This site is Exclusively Sponsored by BRACCO. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. The delivery system is not designed for use with power injection systems. Available in sizes from 1.2 mm to 4.0 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. 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. Do not use if pouch is opened or damaged. Boston Medical Center (BMC) is a 514-bed academic medical center located in Boston's historic South End, providing medical care for infants, children, teens and adults. %PDF-1.7 % Data on file. 2023 Boston Scientific Corporation or its affiliates. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug Store in a cool, dark, dry place. 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. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Disposable devices intended to assist implantation may be included. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. A sales representive will get in touch with you shortly. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Coronary artery spasm in the absence of a significant stenosis. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. THE List - MRI Safety Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The device is typically intended for long-term, but not permanent, implantation. 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. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. 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. 1.5,3: Safe More. GMDN Names and Definitions: Copyright GMDN Agency 2015. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. MRI exams require people to lie still for the entire length of the study. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. 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. Magnetic Resonance Imaging (MRI) | Boston Medical Center We are committed to providing the best experience possible for our patients and visitors. MR Safety and Imaging of Neuroform Stents at 3T Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . 44, no. 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. 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. The SYNERGY. Do not attempt to break, damage, or disrupt the stent after placement. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. 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 technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q hUmo0+}B~Dx&~XQT,%DN nU|w{p The compatibility of the device has not been evaluated for the delivery of materials (e.g. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. Bench test results may not necessarily be indicative of clinical performance. Find products, medical specialty information, and education opportunities. for the treatment of iliofemoral venous occlusive disease. Polaris Ultra Ureteral Stent Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. NC EMERGE PTCA Dilatation Catheter - Boston Scientific A patient with the VICI VENOUS STENT can be scanned safely, immediately after placement, in an MR system meeting the following conditions: o Static magnetic field of 1.5 T or 3.0 T only. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Do not expose the delivery system to organic solvents, e.g., alcohol. To assess the safety and effectiveness of the Venovo Venous Stent 0 Different test methods may yield different results. All rights reserved. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. The technologist performing the exam will monitor the patient throughout the scan and they are also able to talk with each other the entire time. 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. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. All rights reserved. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. Bench tests may not be indicative of clinical performance. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. 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. 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. Testing completed by Boston Scientific Corporation. Do not use the device with contralateral access. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. The safety and effectiveness of this device for use in the arterial system have not been established. For people having an enterography exam, they will be given an oral contrast as well and will need to wait 2 hours after drinking it to allow it to coat their intestines completely. %%EOF o. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. BD and the BD Logo are trademarks of Becton, Dickinson and Company. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. outflow obstruction. Boston Scientific Announces Results for First Quarter 2023 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). 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. 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. 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). Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. All rights reserved. 98 subjects x-rays were analyzed and no stent fractures were reported. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 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. 617.638.8000. Several of these demonstrated magnetic field interactions. Venovo Venous Stent System - BD Fortunately, the devices that exhibited po . Data on file. 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. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Never use air or any gaseous medium to inflate the balloon. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Find products, medical specialty information, and education opportunities. Missing x-ray analyses were recorded as protocol deviations. 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). 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. 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. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. All rights reserved. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. 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. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. AccessGUDID - DEVICE: Ascerta (08714729802976) One Boston Medical Center Place The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. 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. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan 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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