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? By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Find products, medical specialty information, and education opportunities. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . Available in sizes from 1.2 mm to 4.0 mm. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design. THE List - MRI Safety All stents should be deployed in accordance with the manufacturers indications and instructions for use. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 The Venovo Venous Stent System is supplied sterile and is intended for single use only. 98 subjects x-rays were analyzed and no stent fractures were reported. 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. 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. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). 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. We are committed to providing the best experience possible for our patients and visitors. Note: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 2023 Boston Scientific Corporation or its affiliates. *6 F guide catheter with a minimum 0.070 ID, 8 F guide catheter with a minimum 0.088 ID. One Boston Medical Center Place Bench test results may not necessarily be indicative of clinical performance. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange Testing completed by Boston Scientific Corporation. 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 ;;>BFZQC. 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 There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. The long-term outcomes following repeat dilatation of endothelialized stents are unknown. 1.5 . We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. 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. Any patient receiving IV contrast as part of their exam also receives a blood test to make sure the contrast is safe for them. All rights reserved. MRI may not be recommended if for people who have a pacemaker or other metal implants. THE List - MRI Safety Do not use if pouch is opened or damaged. 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. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. 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. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. 1.5,3: Safe More. 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 MR Safety and Imaging of Neuroform Stents at 3T 2023 Boston Scientific Corporation or its affiliates. This depends on the exam the doctor has ordered. 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). Disposable devices intended to assist implantation may be included. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. Do not expand the balloon if it is not properly positioned in the vessel. CAUTION: The law restricts these devices to sale by or on the order of a physician. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Once the test has been completed people can return home and resume normal activities. Then the patient is brought out of the scanner. %PDF-1.7 % The SYNERGY. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. Do not expose the delivery system to organic solvents, e.g., alcohol. 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. 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. hUmo0+}B~Dx&~XQT,%DN nU|w{p Dake, Michael D, et al. MRI Information for Healthcare Professionals - Boston Scientific 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 $ fG1012p("3| 2 Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. alcohol or nitroglycerine, stem cells, etc.) The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. 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. Reproduced with Permission from the GMDN Agency. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Several of these demonstrated magnetic field interactions. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Find out who we are, explore careers at the company, and view our financial performance. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. 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. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Data on file. 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 ). EMERGE PTCA Dilatation Catheter - Boston Scientific 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. Access our instructions for use and product manuals library. Several of these demonstrated magnetic field interactions. through the guidewire lumen, other than those required for normal use. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 1.5, 3: Conditional 5 More. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. The device is intended for use by physicians who have received appropriate training. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Boston Scientific Announces Results for First Quarter 2023 Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All other trademarks are the property of their respective owners. The device is typically intended for long-term, but not permanent, implantation. We host and take part in events that excel in advancing the world of health. 2Radial resistive force was tested at 13 mm crimp diameter (1 mm oversizing) using a radial expansion force gauge. Do not use the device after the Use By date specified on the label. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. Data on file. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. 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. Find products, medical specialty information, and education opportunities. Find out who we are, explore careers at the company, and view our financial performance. The Freedom from TLR rate at 36 months was 88.1%. 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 Missing x-ray analyses were recorded as protocol deviations. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. outflow obstruction. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Polymeric ureteral stent 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. endstream endobj startxref 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. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 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. Venovo Venous Stent System - BD Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. AccessGUDID - DEVICE: Ascerta (08714729802976) 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. 2805 0 obj <>stream Different test methods may yield different results. Recorded at the London Charing Cross Symposium in 2019. Patients must remain still and quiet for the entire exam, as any movement, even speaking, can make the images blurry. SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ Boston Scientific Corporation 300 Boston Scientific. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. Data on file. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. 617.638.8000. 2023 Boston Scientific Corporation or its affiliates. 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation 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. NC EMERGE Indications, Safety, and Warnings - Boston Scientific 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). 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. At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. EMERGE PTCA Dilatation Catheter. Do not exceed the balloon rated burst pressure. 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. The safety and effectiveness of this device for use in the arterial system have not been established. BD offers training resources to help improve your clinical practices as part of our goal of advancing the world of health. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. Find out who we are, explore careers at the company, and view our financial performance. Bench tests may not be indicative of clinical performance. All rights reserved. Data on file, BD Peripheral Intervention, Tempe, AZ. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . This site is Exclusively Sponsored by BRACCO. Do not resterilize and/or reuse the device. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. 0 BD and the BD Logo are trademarks of Becton, Dickinson and Company. Some people may need an IV put in place so caregivers can inject a contrast solution into their veins. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 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. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Coronary artery spasm in the absence of a significant stenosis. 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". Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. 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 A sales representive will get in touch with you shortly. GMDN Names and Definitions: Copyright GMDN Agency 2015. 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 average MRI exam takes about 45 minutes. Fortunately, the devices that exhibited po . 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. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. 44, no. Freedom from MAE was 93.5%, demonstrating a statistically significant difference from a literature-derived PG of 89%.