boston scientific emerge stent mri safety

EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. The Freedom from TLR rate at 36 months was 88.1%. Data on file. 2023 Boston Scientific Corporation or its affiliates. Use only the recommended balloon inflation medium. MR Safety and Imaging of Neuroform Stents at 3T On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Do not attempt to break, damage, or disrupt the stent after placement. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Reproduced with Permission from the GMDN Agency. We are committed to providing the best experience possible for our patients and visitors. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. If excessive force is felt during stent deployment, do not force the delivery system. All other trademarks are the property of their respective owners. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. During system flushing, observe that saline exits at the catheter tip. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. PDF Summary of Safety and Effectivness (SSED)Template 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. 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. THE List - MRI Safety MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. Find out who we are, explore careers at the company, and view our financial performance. A sales representive will get in touch with you shortly. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. 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). Do not exceed the balloon rated burst pressure. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. 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 Find products, medical specialty information, and education opportunities. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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). 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific $ fG1012p("3| 2 Once the test has been completed people can return home and resume normal activities. 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. Safety of Magnetic Resonance Imaging in Patients With - Circulation This depends on the exam the doctor has ordered. MRI may not be recommended if for people who have a pacemaker or other metal implants. EMERGE PTCA Dilatation Catheter. 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. for the treatment of iliofemoral venous occlusive disease. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange 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. 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 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. Receive Updates. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). THE List - MRI Safety Available in sizes from 1.2 mm to 4.0 mm. Missing x-ray analyses were recorded as protocol deviations. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. The device is typically intended for long-term, but not permanent, implantation. MRI also has one exam that uses oral contrast to help visualize the digestive track. All rights reserved. Different test methods may yield different results. Data on file. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The compatibility of the device has not been evaluated for the delivery of materials (e.g. Fortunately, the devices that exhibited po . BD and the BD Logo are trademarks of Becton, Dickinson and Company. 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. Premarket Submission Number Not Available/Not Released. To obtain copies images, please call the film library at 617.414.5882. Choose from Monorail and Over-the-Wire Catheter options. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The Venovo Venous Stent System is supplied sterile and is intended for single use only. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. MRI Information for Healthcare Professionals - Boston Scientific 1.5, 3: Conditional 5 More. 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? Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. endstream endobj startxref 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. 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. EMERGE PTCA Dilatation Catheter - Boston Scientific 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. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. Data on file. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Epub 2021 Sep 20. Magnetic Resonance Imaging (MRI) | Boston Medical Center By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. All rights reserved. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Bench test results may not necessarily be indicative of clinical performance. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. The safety and effectiveness of this device for use in the arterial system have not been established. 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. 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. This site is Exclusively Sponsored by BRACCO. 2023 BD. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. The device is intended for use by physicians who have received appropriate training. Disposable devices intended to assist implantation may be included. Dake, Michael D, et al. 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. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. CAUTION: The law restricts these devices to sale by or on the order of a physician. Store in a cool, dark, dry place. 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). In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Directions for Use. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . 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. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. Data on file. 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. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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). TLR is defined as the first revascularization procedure in the target vessel(s) following the index procedure, as determined by an Independent Core Lab. 2023 Boston Scientific Corporation or its affiliates. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. o. 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 ordering physician will go over the findings with their patient. 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. Do not expand the balloon if it is not properly positioned in the vessel. 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. Bench tests may not be indicative of clinical performance. MRI exams require people to lie still for the entire length of the study. outflow obstruction. Do not use if pouch is opened or damaged. 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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 hUmo0+}B~Dx&~XQT,%DN nU|w{p Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. 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. SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System %%EOF 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. 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". 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. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. The device is typically intended for long-term, but not permanent, implantation. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. hbbd```b``>"tH/ Remove the delivery system and replace with a new unit. The SYNERGY. AccessGUDID - DEVICE: Tria Soft (08714729959915) To assess the safety and effectiveness of the Venovo Venous Stent Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Do not use the device after the Use By date specified on the label. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. All rights reserved. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. ;;>BFZQC. Data on file. 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). For decades, we have worked together to define the future. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 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 NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. 2785 0 obj <> endobj 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 AccessGUDID - DEVICE: Ascerta (08714729802976) Boston Scientific, www.bostonscientific.com . Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. 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. 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. 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 Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. 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. Then the patient is brought out of the scanner. 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 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. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. All rights reserved. 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. NC EMERGE PTCA Dilatation Catheter - Boston Scientific Boston Scientific Announces Results for First Quarter 2023

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