boston scientific emerge stent mri safety

Staff also needs to know specific details about any implants in the body. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%. Data on file. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. endstream endobj startxref 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 technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. THE List - MRI Safety 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. Emerge 0.026 crossing profile measured on 1.2 x 15 mm (n=5) and 1.5 x 15 mm (n = 5) products. Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide Do not expand the balloon if it is not properly positioned in the vessel. 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 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. $ fG1012p("3| 2 Do not attempt to break, damage, or disrupt the stent after placement. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. 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. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange outflow obstruction. Disposable devices intended to assist implantation may be included. 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). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. 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. 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. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. 617.638.8000. Find out who we are, explore careers at the company, and view our financial performance. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q 2805 0 obj <>stream 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 depends on the exam the doctor has ordered. 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. 2785 0 obj <> endobj Find products, medical specialty information, and education opportunities. Do not exceed the balloon rated burst pressure. The image is highly detailed and can show even the smallest abnormality. 1.5 . The delivery system is not designed for use with power injection systems. Data on file. The Venovo Venous Stent System is supplied sterile and is intended for single use only. 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". If difficulty is experienced during balloon inflation, do not continue; remove the catheter. 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. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. 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. 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. Once the scan is complete, the technologist will review the images to make sure all the information needed is there. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. Patients having an enterography, may be at BMC up to 3 hours. All rights reserved. Do not use the device after the Use By date specified on the label. 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. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Coils, Filters, Stents, and Grafts More. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. The SYNERGY. The stent is not designed for repositioning or recapturing. 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). All rights reserved. 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 EMERGE PTCA Dilatation Catheter. We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Fortunately, the devices that exhibited po . Do not use if pouch is opened or damaged. xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! 2023 Boston Scientific Corporation or its affiliates. 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. Several of these demonstrated magnetic field interactions. %PDF-1.7 % Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. Remove the delivery system and replace with a new unit. 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. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. MRI also has one exam that uses oral contrast to help visualize the digestive track. Receive Updates. Several of these demonstrated magnetic field interactions. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Coils, Filters, Stents, and Grafts More. 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. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). If excessive force is felt during stent deployment, do not force the delivery system. Find out who we are, explore careers at the company, and view our financial performance. 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. Find out who we are, explore careers at the company, and view our financial performance. Data on file. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. To obtain copies images, please call the film library at 617.414.5882. 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 Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution. Many exams involve IV contrast, which helps highlight the tissues and give the radiologist different information about an area(s) of interest to help make a diagnosis. 2023 Boston Scientific Corporation or its affiliates. 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. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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). SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System The compatibility of the device has not been evaluated for the delivery of materials (e.g. Boston, MA 02118 C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 2023 Boston Medical Center. 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. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. 1.5,3: Safe More. 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. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . 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. We are committed to providing the best experience possible for our patients and visitors. 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. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 2023 Boston Scientific Corporation or its affiliates. The Freedom from TLR rate at 36 months was 88.1%. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. 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. 2023 BD. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. The ordering physician will go over the findings with their patient. endstream endobj 2789 0 obj <>stream Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. For decades, we have worked together to define the future. The device is typically intended for long-term, but not permanent, implantation. NC EMERGE PTCA Dilatation Catheter - Boston Scientific 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. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm. Dake, Michael D, et al. 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? Choose from Monorail and Over-the-Wire Catheter options. Never use air or any gaseous medium to inflate the balloon. Find out who we are, explore careers at the company, and view our financial performance. All rights reserved. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. During system flushing, observe that saline exits at the catheter tip. EMERGE PTCA Dilatation Catheter - Boston Scientific 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 AccessGUDID - DEVICE: Tria Soft (08714729959915) 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. ;;>BFZQC. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. 1 The 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. Store in a cool, dark, dry place. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. MRI Information for Healthcare Professionals - Boston Scientific Different test methods may yield different results. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). AccessGUDID - DEVICE: Ascerta Firm (08714729861720) 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. All other trademarks are the property of their respective owners. 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. %%EOF Recorded at the London Charing Cross Symposium in 2019. Data on file. We host and take part in events that excel in advancing the world of health. 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. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 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. Reproduced with Permission from the GMDN Agency. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous 12, Dec. 2021, https://doi.org/10.1007/s00270-021- 02975-2. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. Bench tests may not be indicative of clinical performance. hbbd```b``>"tH/ 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. 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. Then the patient is brought out of the scanner. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. 1.5, 3: Conditional 5 More. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. 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. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. Polaris Ultra Ureteral Stent Directions for Use. The technologist monitors the patient the entire time, and may tell the patient to hold their breath for some parts of the exam. Coronary artery spasm in the absence of a significant stenosis. All stents should be deployed in accordance with the manufacturers indications and instructions for use. A sales representive will get in touch with you shortly. 98 subjects x-rays were analyzed and no stent fractures were reported. Epub 2021 Sep 20. Missing x-ray analyses were recorded as protocol deviations. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 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. MRI exams require people to lie still for the entire length of the study. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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 ). Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Safety of Magnetic Resonance Imaging in Patients With - Circulation ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Testing completed by Boston Scientific Corporation. All rights reserved. Bench test results may not necessarily be indicative of clinical performance. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved.
Kings County Animal Shelter, Basil Rathbone Net Worth At Death, Articles B