Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. All other trademarks are the property of their respective owners. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. A sales representive will get in touch with you shortly. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. 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. BD and the BD Logo are trademarks of Becton, Dickinson and Company. Dake, Michael D, et al. The device is typically intended for long-term, but not permanent, implantation. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. THE List - MRI Safety hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Data on file. Use only the recommended balloon inflation medium. Store in a cool, dark, dry place. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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. MRI also has one exam that uses oral contrast to help visualize the digestive track. Visit our ImageReady website to learn more about Boston Scientifics MR-Conditional Pacemakers, ICDs, and Spinal Cord Stimulator (SCS) Systems. ;;>BFZQC. THE List - MRI Safety Bench test results may not necessarily be indicative of clinical performance. Do not expand the balloon if it is not properly positioned in the vessel. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. EMERGE PTCA Dilatation Catheter - Boston Scientific %%EOF 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. Boston Scientific Announces Results for First Quarter 2023 Find out who we are, explore careers at the company, and view our financial performance. 1.5,3: Safe More. 2023 Boston Scientific Corporation or its affiliates. Skip to main content News Careers Investors Region selector Argentina Brazil Chile China Colombia Deutschland Espanol Europe India Japan Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Disposable devices intended to assist implantation may be included. 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. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. THE List - MRI Safety All rights reserved. 617.638.8000. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. Data on file. Never use air or any gaseous medium to inflate the balloon. Data on file. We host and take part in events that excel in advancing the world of health. Disposable devices intended to assist implantation may be included. through the guidewire lumen, other than those required for normal use. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. CAUTION: The law restricts these devices to sale by or on the order of a physician. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. The Venovo Venous Stent System is supplied sterile and is intended for single use only. All rights reserved. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 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. 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. 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. 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. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. During system flushing, observe that saline exits at the catheter tip. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! GMDN Names and Definitions: Copyright GMDN Agency 2015. 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. Fortunately, the devices that exhibited po . 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. The safety and effectiveness of this device for use in the arterial system have not been established. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. alcohol or nitroglycerine, stem cells, etc.) 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). A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. 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. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Boston Scientific, www.bostonscientific.com . The device is intended for use by physicians who have received appropriate training. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). 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. 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. 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. 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. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. 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. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. MRI exams require people to lie still for the entire length of the study. 44, no. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. Different test methods may yield different results. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Missing x-ray analyses were recorded as protocol deviations. Polaris Ultra Ureteral Stent Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. 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. 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). AccessGUDID - DEVICE: Tria Soft (08714729959915) 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). To obtain copies images, please call the film library at 617.414.5882. 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. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Do not use the device with contralateral access. The average MRI exam takes about 45 minutes. 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. Boston, MA 02118 C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. All rights reserved. 2023 Boston Scientific Corporation or its affiliates. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 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. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Data on file, BD Peripheral Intervention, Tempe, AZ. Data on file. Bench test results may not necessarily be indicative of clinical performance. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. Find products, medical specialty information, and education opportunities. 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. 0 Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Epub 2021 Sep 20. For decades, we have worked together to define the future. 98 subjects x-rays were analyzed and no stent fractures were reported. 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. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. 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. 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. Data on file. Data on file. 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.

I Don't Like My Friend Anymore For No Reason, Are Eddie And Katherine Still Together, Ktvu Reporters Leaving, Articles B