Dake, Michael D, et al. 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 Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. The Freedom from TLR rate at 36 months was 88.1%. hbbd```b``>"tH/ 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 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. 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. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. 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 Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. One Boston Medical Center Place The device is typically intended for long-term, but not permanent, implantation. Use only the recommended balloon inflation medium. All rights reserved. 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. Do not expand the balloon if it is not properly positioned in the vessel. 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. 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. 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". The stent is not designed for repositioning or recapturing. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. Epub 2021 Sep 20. Coils, Filters, Stents, and Grafts More. Coronary artery spasm in the absence of a significant stenosis. 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. 2023 Boston Scientific Corporation or its affiliates. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. alcohol or nitroglycerine, stem cells, etc.) On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . 1.5,3: Safe More. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Data on file. 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. 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. Note: Boston Scientific Corporation is not responsible for correct use of codes on . Find products, medical specialty information, and education opportunities. Polaris Ultra Ureteral Stent Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Data on file. 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). 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. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. %PDF-1.7 % 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. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. During system flushing, observe that saline exits at the catheter tip. 98 subjects x-rays were analyzed and no stent fractures were reported. Premarket Submission Number Not Available/Not Released. Disposable devices intended to assist implantation may be included. 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. Store in a cool, dark, dry place. 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. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. MRI also has one exam that uses oral contrast to help visualize the digestive track. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 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. 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, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. 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. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . Do not expose the delivery system to organic solvents, e.g., alcohol. If a long lesion needs to be stented consider using the longest available stent rather than overlapping 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). This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. CAUTION: The law restricts these devices to sale by or on the order of a physician. All other trademarks are the property of their respective owners. The compatibility of the device has not been evaluated for the delivery of materials (e.g. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 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. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. 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. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. MRI exams require people to lie still for the entire length of the study. 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. 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. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Coils, Filters, Stents, and Grafts More. Boston, MA 02118 With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. All rights reserved. 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. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. To assess the safety and effectiveness of the Venovo Venous Stent Stents were evaluated at the 36-month follow-up for fracture analysis. 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. Patients having an enterography, may be at BMC up to 3 hours. 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. 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. 2023 Boston Scientific Corporation or its affiliates. 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. Then the patient is brought out of the scanner. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Find products, medical specialty information, and education opportunities. outflow obstruction. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Find out who we are, explore careers at the company, and view our financial performance. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. 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 The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. Find out who we are, explore careers at the company, and view our financial performance. $ fG1012p("3| 2 Available in sizes from 1.2 mm to 4.0 mm. Find products, medical specialty information, and education opportunities. Testing completed by Boston Scientific Corporation. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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 Bench test results may not necessarily be indicative of clinical performance. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. 2023 BD. 44, no. 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. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. 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). Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Never use air or any gaseous medium to inflate the balloon. 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. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. 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. If excessive force is felt during stent deployment, do not force the delivery system. %%EOF Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Staff also needs to know specific details about any implants in the body. All rights reserved. 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. We host and take part in events that excel in advancing the world of health. Data on file. 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. 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 All rights reserved. Do not use if pouch is opened or damaged. Testing completed by Boston Scientific Corporation. Recorded at the London Charing Cross Symposium in 2019. 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). how to open a swingline stapler model 8784x, countess vaughn mom,
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