%PDF-1.7 % Data on file. Find products, medical specialty information, and education opportunities. Epub 2021 Sep 20. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. Data on File. 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 Missing x-ray analyses were recorded as protocol deviations. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. 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. The delivery system is not designed for use with power injection systems. MRI also has one exam that uses oral contrast to help visualize the digestive track. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. Fortunately, the devices that exhibited po . C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. 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. Data on file. Data on file, BD Peripheral Intervention, Tempe, AZ. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Bench test results may not necessarily be indicative of clinical performance. 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. Several of these demonstrated magnetic field interactions. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. The stent is not designed for repositioning or recapturing. 2023 Boston Medical Center. Data on file. $ fG1012p("3| 2 Boston Scientific, www.bostonscientific.com . Store in a cool, dark, dry place. 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. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . Once the test has been completed people can return home and resume normal activities. 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. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. 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. 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 Stents were evaluated at the 36-month follow-up for fracture analysis. alcohol or nitroglycerine, stem cells, etc.) 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). Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Testing completed by Boston Scientific Corporation. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. 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. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. Dake, Michael D, et al. This site is Exclusively Sponsored by BRACCO. People who are claustrophobic, should consult their physician prior to the day of the appointment for assistance, as the department is not licensed to dispense medication. If excessive force is felt during stent deployment, do not force the delivery system. 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. The device is typically intended for long-term, but not permanent, implantation. 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. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Patients having an enterography, may be at BMC up to 3 hours. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. hbbd```b``>"tH/ One Boston Medical Center Place 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. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. Do not attempt to break, damage, or disrupt the stent after placement. Use only the recommended balloon inflation medium. Find products, medical specialty information, and education opportunities. EMERGE PTCA Dilatation Catheter. 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). CAUTION: The law restricts these devices to sale by or on the order of a physician. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). 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. 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 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. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. 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). 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. 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. 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. 1.5 . 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. outflow obstruction. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Recorded at the London Charing Cross Symposium in 2019. 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. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP 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). ;;>BFZQC. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. All stents should be deployed in accordance with the manufacturers indications and instructions for use. Several of these demonstrated magnetic field interactions. Choose from Monorail and Over-the-Wire Catheter options. 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. Find out who we are, explore careers at the company, and view our financial performance. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. The ordering physician will go over the findings with their patient. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. MRI may not be recommended if for people who have a pacemaker or other metal implants. Bench tests may not be indicative of clinical performance. 2023 Boston Scientific Corporation or its affiliates. The device is typically intended for long-term, but not permanent, implantation. 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 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. Find out who we are, explore careers at the company, and view our financial performance. Never use air or any gaseous medium to inflate the balloon. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. Different test methods may yield different results. Do not use if pouch is opened or damaged. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Disposable devices intended to assist implantation may be included. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. All rights reserved. To assess the safety and effectiveness of the Venovo Venous Stent 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. 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. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Do not resterilize and/or reuse the device. 1.5, 3: Conditional 5 More. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 98 subjects x-rays were analyzed and no stent fractures were reported. A sales representive will get in touch with you shortly. The compatibility of the device has not been evaluated for the delivery of materials (e.g. 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 safety and effectiveness of this device for use in the arterial system have not been established. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Coils, Filters, Stents, and Grafts More. 44, no. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. For decades, we have worked together to define the future. 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. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Staff also needs to know specific details about any implants in the body. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. 617.638.8000. All rights reserved. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. 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. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Available in sizes from 1.2 mm to 4.0 mm. 2023 BD. Access our instructions for use and product manuals library. The average MRI exam takes about 45 minutes. 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. Reproduced with Permission from the GMDN Agency. See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EMERGE PTCA Dilatation Catheter - Boston Scientific, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Exceptional deliverability and low profiles designed to cross tight lesions, High rated burst pressure 18 ATM (1824 kPa) for sizing flexibility, Two shaft designs provide options for challenging lesions, EMERGE Catheter is designed for exceptional simultaneous use performance, Shaft profile allows for simultaneous use of two Monorail catheters in a 6 F guide catheter and two Over-the-Wire catheters in an 8 F guide catheter*, Designed to optimize stent apposition in large, proximal vessels, Two shaft options with distinct technologies designed to provide flexibility for navigating to and through even the most challenging lesions, Push technology: Single-segment inner shaft design for ultimate pushability 1.2 mm and 1.5 mm Push, Workhorse technology: Bi-Segment inner shaft designed for maximum deliverability without sacrificing pushability (1.2 mm to 4.0 mm). Coils, Filters, Stents, and Grafts More. 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. 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? 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 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. through the guidewire lumen, other than those required for normal use. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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 advance or retract the catheter unless the balloon is fully deflated under vacuum. %%EOF All other trademarks are the property of their respective owners. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Do not use the device after the Use By date specified on the label. Receive Updates. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. for the treatment of iliofemoral venous occlusive disease. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. 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. 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. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Find products, medical specialty information, and education opportunities. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. This depends on the exam the doctor has ordered. Data on file. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. During system flushing, observe that saline exits at the catheter tip. Bench test results may not necessarily be indicative of clinical performance. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We host and take part in events that excel in advancing the world of health. 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 o. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 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. 2785 0 obj <> endobj BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. 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. 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. All rights reserved. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Do not expand the balloon if it is not properly positioned in the vessel. 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
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