Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. 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. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 2023 Boston Scientific Corporation or its affiliates. 2785 0 obj <> endobj Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. The ordering physician will go over the findings with their patient. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy. EMERGE is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. The image is highly detailed and can show even the smallest abnormality. 5.7 MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION . 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 test has been completed people can return home and resume normal activities. BD promotes clinical excellence by providing various resources on best practices, clinical innovations and industry trends in healthcare. 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. *(c5PH e&@J2CdR5GF*x:@8qN[[{G(2KdI Y]\{h Qd(3F1KH>uM0Z1KCJO^lEuuBSGZTQIQ}6 Do not use the device after the Use By date specified on the label. 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. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. 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. Secondary endpoints included acute technical success, Quality of Life (QoL) assessment, Venous Clinical Severity Score (VCSS Pain score) and stent fractures. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. The technologist will then remove the IV, if applicable, and bring the patient out of the room to change back into their clothes. 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. Safe MR imaging involves a careful initial patient screening, accurate determination of the permanent implanted or temporary cardiovascular device and its properties, a thoughtful analysis of the risks and benefits of performing the examination at that time, and, when indicated, appropriate physician management and supervision. Do not expand the balloon if it is not properly positioned in the vessel. Single and Overlapping Stents up to 120-mm Boston Scientific www.bostonscientific.com . MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. During system flushing, observe that saline exits at the catheter tip. Boston, MA 02118 At Boston Medical Center, research efforts are imperative in allowing us to provide our patients with quality care. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. The SYNERGY. MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. On all models 2.75 mm x 20 mm and 30 mm length balloons 2.25 mm. hbbd```b``>"tH/ The Freedom from TLR rate at 36 months was 88.1%. Never use air or any gaseous medium to inflate the balloon. Use only the recommended balloon inflation medium. Data on file. Disposable devices intended to assist implantation may be included. Then the patient is brought out of the scanner. Once the radiologist reads the images, the ordering physician will typically receive the results within 24 to 48 hours. Do not use in patients with total venous occlusion that cannot be dilated to allow passage of the guidewire. To assess the safety and effectiveness of the Venovo Venous Stent 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. Data on file. Data on file. Data on file, BD Peripheral Intervention, Tempe, AZ. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Several of these demonstrated magnetic field interactions. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 2023 Boston Medical Center. If excessive force is felt during stent deployment, do not force the delivery system. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death. Find out who we are, explore careers at the company, and view our financial performance. Staff also needs to know specific details about any implants in the body. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. 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 Do not attempt to break, damage, or disrupt the stent after placement. GMDN Names and Definitions: Copyright GMDN Agency 2015. By bringing technology and performancetogether, we continue our commitment to evolving balloon catheter technology. Do not exceed the balloon rated burst pressure. BD supports the healthcare industry with market-leading products and services that aim to improve care while lowering costs. A specialist is capable of seeing and understanding subtle things due to advanced training and singular focus. 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. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. CAUTION: The law restricts these devices to sale by or on the order of a physician. With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. 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. 2805 0 obj <>stream Patients having an enterography, may be at BMC up to 3 hours. All rights reserved. Coronary artery spasm in the absence of a significant stenosis. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous ;;>BFZQC. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Find products, medical specialty information, and education opportunities. If difficulty is experienced during balloon inflation, do not continue; remove the catheter. Premarket Submission Number Not Available/Not Released. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. 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. We host and take part in events that excel in advancing the world of health. 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). Testing completed by Boston Scientific Corporation. The device is typically intended for long-term, but not permanent, implantation. %PDF-1.7 % Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. Boston Scientific, www.bostonscientific.com . All stents should be deployed in accordance with the manufacturers indications and instructions for use. This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice. 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. 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. 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. Receive Updates. Do not resterilize and/or reuse the device. Find products, medical specialty information, and education opportunities. Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. The delivery system is not designed for use with power injection systems. 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. Bench test results may not necessarily be indicative of clinical performance. Safety Topic / Subject Wallstent Endoprosthesis Magic Wallstent 3.5 x 25 coil, stent, filter Schneider (USA) Inc. . Choose from Monorail and Over-the-Wire Catheter options. GMDN Names and Definitions: Copyright GMDN Agency 2015. There is no preparation necessary for an MRI except for people having an exam called an MRCP, an exam of the gallbladder and the ducts associated with it, or an enterography. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). hUmo0+}B~Dx&~XQT,%DN nU|w{p The device is intended for use by physicians who have received appropriate training. Store in a cool, dark, dry place. This site is Exclusively Sponsored by BRACCO. 1.5,3: Safe More. endstream endobj startxref 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. 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 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. 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). Changing Clinical Practice: Venous Experts Discuss the VenovoVenous Stent. Data on file. 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. 2023 Boston Scientific Corporation or its affiliates. Persons with allergic reactions to nitinol (nickel-titanium) alloy and/or tantalum may suffer an allergic response to this implant. 1.5 . The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. All rights reserved. Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. 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. One Boston Medical Center Place Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. All rights reserved. If a long lesion needs to be stented consider using the longest available stent rather than overlapping stents. All rights reserved. 617.638.8000. All rights reserved. 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. 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 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. hb```vA1 8#3Y+8%j+2(fE3Y;&0i_9*=q Bench tests may not be indicative of clinical performance. The device is typically intended for long-term, but not permanent, implantation. 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 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. Directions for Use. Data on file. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. 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. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. 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. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. 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. People scheduled for an MRI should expect to be at BMC for about 1-1.5 hours. 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. MRI exams require people to lie still for the entire length of the study. Available in sizes from 1.2 mm to 4.0 mm. Crossing profile is defined as the maximum diameter found between the proximal end of the balloon and the distal tip of the catheter. Find products, medical specialty information, and education opportunities.

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