To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis. %PDF-1.7 % The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. PDF Summary of Safety and Effectivness (SSED)Template Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. THE List - MRI Safety Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Patients who received a Venovo Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.7% PP rate for subjects with post-thrombotic syndrome and 97.1% PP rate for subjects with non-thrombotic iliac vein lesions. 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 The Venovo Venous Stent System is supplied sterile and is intended for single use only. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. All rights reserved. Testing completed by Boston Scientific Corporation. 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 for the treatment of iliofemoral venous occlusive disease. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Do not use the device with contralateral access. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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 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. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. If excessive force is felt during stent deployment, do not force the delivery system. 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. 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). All other trademarks are the property of their respective owners. 1.5,3: Safe More. MRI exams require people to lie still for the entire length of the study. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Reproduced with Permission from the GMDN Agency. Fortunately, the devices that exhibited po . We are committed to providing the best experience possible for our patients and visitors. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. Patients having an enterography, may be at BMC up to 3 hours. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 2023 BD. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Data on file. 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). Directions for Use. Coils, Filters, Stents, and Grafts More. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. The stent is not designed for repositioning or recapturing. Never use air or any gaseous medium to inflate the balloon. The device is typically intended for long-term, but not permanent, implantation. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous 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". 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. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). endstream endobj startxref The image is highly detailed and can show even the smallest abnormality. 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. outflow obstruction. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. Use only the recommended balloon inflation medium. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Find products, medical specialty information, and education opportunities. 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. The safety and effectiveness of this device for use in the arterial system have not been established. 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. 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. Epub 2021 Sep 20. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, potential complications, adverse events and detailed safety information. CAUTION: The law restricts these devices to sale by or on the order of a physician. 2805 0 obj <>stream Data on file. To obtain copies images, please call the film library at 617.414.5882. $ fG1012p("3| 2 xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 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). ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. This site is Exclusively Sponsored by BRACCO. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 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 use the device after the Use By date specified on the label. MRI also has one exam that uses oral contrast to help visualize the digestive track. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. Recorded at the London Charing Cross Symposium in 2019. 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. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. 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. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. Definition excerpted from FDA Guidance document titled, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. 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. 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 Note: Boston Scientific Corporation is not responsible for correct use of codes on . Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. Receive Updates. 1.5 . Data on file. 2023 Boston Scientific Corporation or its affiliates. Reproduced with Permission from the GMDN Agency. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Boston Scientific, www.bostonscientific.com . Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. BD and the BD Logo are trademarks of Becton, Dickinson and Company. 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). 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 Freedom from TLR rate at 36 months was 88.1%. 2785 0 obj <> endobj 617.638.8000. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. 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. THE List - MRI Safety There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Dake, Michael D, et al. 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). Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. MR Safety and Imaging of Neuroform Stents at 3T 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 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. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan 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. 0 The SYNERGY. Find out who we are, explore careers at the company, and view our financial performance. SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices.

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