GMDN Names and Definitions: Copyright GMDN Agency 2015. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. 2805 0 obj <>stream BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. All rights reserved. The Freedom from TLR rate at 36 months was 88.1%. Store in a cool, dark, dry place. Once the test has been completed people can return home and resume normal activities. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Reproduced with Permission from the GMDN Agency. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 98 subjects x-rays were analyzed and no stent fractures were reported. 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 During system flushing, observe that saline exits at the catheter tip. All other trademarks are the property of their respective owners. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. The device is typically intended for long-term, but not permanent, implantation. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Data on File. 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 Data on file. Do not use the device after the Use By date specified on the label. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! Several of these demonstrated magnetic field interactions. Available in sizes from 1.2 mm to 4.0 mm. Stents were evaluated at the 36-month follow-up for fracture analysis. 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. Dake, Michael D, et al. Find out who we are, explore careers at the company, and view our financial performance. hUmo0+}B~Dx&~XQT,%DN nU|w{p Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. All other trademarks are the property of their respective owners. 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). 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. Disposable devices intended to assist implantation may be included. 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 residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. The safety and effectiveness of this device for use in the arterial system have not been established. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous 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. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. The compatibility of the device has not been evaluated for the delivery of materials (e.g. 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. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Data on file. Coronary artery spasm in the absence of a significant stenosis. If excessive force is felt during stent deployment, do not force the delivery system. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 Disposable devices intended to assist implantation may be included. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Never use air or any gaseous medium to inflate the balloon. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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). Premarket Submission Number Not Available/Not Released. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. 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. Find products, medical specialty information, and education opportunities. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. All rights reserved. Note: Boston Scientific Corporation is not responsible for correct use of codes on . o. 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR 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). outflow obstruction. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Find products, medical specialty information, and education opportunities. 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. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. 2023 Boston Scientific Corporation or its affiliates. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. for the treatment of iliofemoral venous occlusive disease. 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. The Venovo Venous Stent System is supplied sterile and is intended for single use only. All stents should be deployed in accordance with the manufacturers indications and instructions for use. 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. Reusing this medical device bears the risk of cross-patient contamination as medical devices particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. To assess the safety and effectiveness of the Venovo Venous Stent 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. Staff also needs to know specific details about any implants in the body. The stent is not designed for repositioning or recapturing. 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. Different test methods may yield different results. 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. Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. 2023 Boston Medical Center. 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. MRI may not be recommended if for people who have a pacemaker or other metal implants. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. 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. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. Find out who we are, explore careers at the company, and view our financial performance. 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. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information 170 subjects at 21 sites in the U.S., Europe, and Australia/New Zealand, * Evaluated against literature derived performance goal of 74% for efficacy (p<.0001) and 89% for safety (p=.032), 1The Venovo Venous Stent System was studied in the global VERNACULAR clinical trial, which was a prospective, multi-center, non-randomized, single-arm study of 170 patients. 2023 Boston Scientific Corporation or its affiliates. All rights reserved. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. The Neuroform (Boston Scientific Corporation, Natick, MA) stent is a self-expanding nitinol stent designed to assist the endovascular placement of detachable coils in wide-necked intracranial aneurysms ( 1, 2 ). Do not expand the balloon if it is not properly positioned in the vessel. Data on file. Recorded at the London Charing Cross Symposium in 2019. 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. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. The device is intended for use by physicians who have received appropriate training. 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. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 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 Find products, medical specialty information, and education opportunities. Testing completed by Boston Scientific Corporation. Do not exceed the balloon rated burst pressure. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Testing completed by Boston Scientific Corporation. Do not expose the delivery system to organic solvents, e.g., alcohol. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. 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. Find out who we are, explore careers at the company, and view our financial performance. 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 long-term outcomes following repeat dilatation of endothelialized stents are unknown. The delivery system is not designed for use with power injection systems. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge.
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