Dr. med. Dr. med. A brain aneurysm is a weak, bulging spot on the wall of an artery. Delivers atraumatic flow arrest without sacrificing aspiration power or time. Small-Cell Lung Cancer Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Pl Ventilator Associated Pneumonia (VAP) Clinical Trial Anaylsis by Trial Phase, Trial Status, Trial Surmodics enrols first patents in Pounce Thrombectomy System study, Ancora Heart selects Egnites AI technology for AccuCinchs trial, Baymatob completes pilot study on AI-guided labour monitoring device Oli, Senseonics announces first paediatric insertion for Eversense in trial. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. With stainless steel double braid and five transition zones. Please consult the device Instruction For Use for more information. We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. When typing in this field, a list of search results will appear and be automatically updated as you type. Access products allow doctors to gain access to the treatment area. Integrated guiding catheter system offering support and a large inner diameter lumen, featuring a unique inner catheter option for rapid atraumatic access, Thin PTFE layer and flat wire braid creates increased lumen diameter, Soft inner catheter options with Hydrophilic Coating. About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Now its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice, such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Next Article The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro. The new balloon guide catheter has been designed for use in enabling insertion and intravascular catheter guidance into a selected blood vessel in the peripheral and neurovascular systems. Indications may vary by region. MicroVention, Inc., a subsidiary of Terumo and a global neurovascular company, announced the first U.S. clinical case of its next generation Flow Diverter, the FRED X device, at Thomas Jefferson University Hospital located in Philadelphia. It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. The STRAIT studys Principal Investigator is Professor Tobias Boeckh-Behrens, MD, of Department of Diagnostic and Interventional Neuro Radiology at Klinikum rechts der Isar der Technischen Universitt Mnchen in Munich, Germany, where the first patient in the study was enrolled. The guidewire can be steered to facilitate the selective. Our Story. (Uploaded on November 18, 2016. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a multi-center, prospective EU observational study called STRAIT, to evaluate the Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute IschemicStroke. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. All Rights Reserved Privacy Policy. Learn More. Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. . Terumo will further strive to be of value to patients, medical professionals, and society at large. A catheter is a hollow, flexible tube inserted into a vessel to allow the passage of fluids or distend a passageway. Dr. med. The SOFIA Catheter is not intended for use in coronary arteries. This year, 80% of employees said its a great place to work 21 points higher than the average U.S. company. The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. View All Products Scepter C & Scepter XC Balloon Catheters 04 Microcatheters Visit our contact page for information on how to place an order by phone, fax or email. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. We took a novel approach by designing a ready-to-use liquid embolic device formalformations. We were pleased with the excellent performance of the BOBBYBGCwith the SOFIA Plus 6Fr Aspiration Catheter, Headway Microcatheter, Traxcess EX Guidewire and the 6x40 stent retriever revascularization device. The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. The Traxcess 14 guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Indications may vary by region. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Find clinical trials, studies and registries involving this product. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. The BOBBY Balloon Guide Catheter is intended For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. Created with Sketch. The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). We were pleased with the excellent performance of the BOBBY BGC with the SOFIA Plus 6Fr Aspiration Catheter, Headway Microcatheter, Traxcess EX Guidewire and the 6x40 stent retriever revascularization device., Carsten Schroeder, President and CEO of MicroVention, Inc. noted that, The STRAIT trial is intended to provide clinical evidence that MicroVentions new balloon guide catheter can effectively contribute to improved clinical outcomes.. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. Read more Endovascular procedures offer many advantages, including a shorter recovery period, less discomfort, a small incision, and fewer risks for patients that have other medical conditions.*. The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. Terumo will further strive to be of value to patients, medical professionals, and society at large. Aliso Viejo, CA April 20, 2022 MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a multi-center, prospective EU observational study called STRAIT, to evaluate the Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. Balloon Occlusion Device Market Size is projected to Reach Multimillion USD by 2029, In comparison to 2022, at unexpected CAGR during the forecast Period . Visit clinicaltrials.gov for more information. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The Bobby balloon guide catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The device is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. April 20, 2022MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in STRAIT, a multicenter, prospective observational study in the European Union. bobby balloon guide catheter: MicroVention, Inc. K193607: 07/21/2020 via microcatheter (size 17), via microcatheter (size 21), via microcatheter (size 27), via microcatheter (size 33) . Aliso Viejo, California andAlajuela, Costa Rica, April 11, 2023 MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today hosted the Republic of Costa Ricas President Rodrigo Chaves Robles and other government officials and dignitaries at its Costa Rica facility inAlajuela. The device is not intended for use in coronary arteries. Malformations are an abnormal tangle of blood vessels that cause arteries to shunt directly into veins, the blood flow never slows down enough to provide oxygen and nutrients. The Bobby balloon guide catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. Wallaby Medical Acquires German Neurovascular Company Phenox GmbH, left-arrow The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. Ischemic Stroke and Carotid Artery Disease. Find clinical trials, studies and registries involving this product. The device is not intended for use in coronary arteries. The Headway microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. ", Carsten Schroeder, President and CEO of MicroVention, Inc. noted that, "The STRAIT trial is intended to provide clinical evidence that MicroVention's new balloon guide catheter can effectively contribute to improved clinical outcomes.". BOBBY balloon guide catheter thrombectomy in large-vessel occlusion stroke: Initial experience Interv Neuroradiol. The balloon provides temporary vascular occlusion during these and other angiographic procedures. FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. Microcatheters. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Balloon Guide Catheters. Guide catheters are large, robust catheters that allow smaller catheters to pass through and facilitate the placement of various medical devices while providing stability during the procedure. MicroVention is a neuroendovascular medical device company that develops minimally-invasive devices for treatment of vascular diseases in the brain. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. ET. For rapid neurovascular access with a balance of proximal support and distal flexibility. Features and benefits Proximal flow control The Bobby device is also indicated for use as a conduit for retrieval devices. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. Founded in 1997 by a handful of Associates in Southern California, MicroVention is now a worldwide community with over 3,000 Associates and distributors worldwide, with offices across the United States, Europe, Asia, and CostaRica. An intermediate catheter is designed to help provide stability by reducing the tendency of the microcatheter to move during delivery/implantation of medical devices. Guidewires. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Dr. med. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. We were pleased with the excellent performance of the BOBBY BGC with the SOFIA Plus 6Fr Aspiration Catheter, Headway Microcatheter, Traxcess EX Guidewire and the 6x40 stent retriever revascularization device., Carsten Schroeder, President and CEO of MicroVention, Inc. noted that, The STRAIT trial is intended to provide clinical evidence that MicroVentions new balloon guide catheter can effectively contribute to improved clinical outcomes.. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. The new balloon guide catheter has been designed for use in enabling insertion and intravascular catheter guidance into a selected blood vessel in the peripheral and neurovascular systems. The leading site for news and procurement in the medical device industry, Nanotech knowledge grows to progress tuberculosis treatment, Sterilisation innovation to prioritise patient safety, Transcatheter accessories becoming more specialised, MedShift receives $45m loan from Turning Rock, TeraRecon launches new AI-powered Neuro Suite platform, Nuvo Group signs LOI to combine with SPAC to go public, Twinn.health introduces AI-based imaging platform for age-related diseases, FDA grants Ultromics EchoGo Amyloidosis platform breakthrough device status, Medtronic reports increase in Q3 2023 global revenue, BD reports 2.8% decline in Q1 2023 revenues, The six crucial advantages of Software as a Service for eIFU. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Additionally, the Sofia catheter is intended for use in the removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. The SOFIA Catheter is not intended for use in coronary arteries. The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter. A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). The balloon provides temporary vascular occlusion during these and other angiographic procedures. A balloon guide catheter (BGC) is an adjunctive device used to arrest and reverse flow by inflating the balloon at its tip, which allows for flow reversal in intracranial arteries during retrieval of thrombectomy devices by applying concomitant aspiration through its lumen. MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a multi-center, prospective EU observational study called STRAIT, to evaluate the Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. Aliso Viejo, CA April 20, 2022 MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a multi-center, prospective EU observational study called STRAIT, to evaluate the Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. The SOFIA-inspired, multiple transitions zones create a smooth, trackable, and stable experience. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). About TraxcessEX GuidewireThe Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. We will accomplish this goal by producing the most reliable . A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. Terumos wholly-owned subsidiary MicroVention has announced the enrolment of the first participant in the STRAIT study of its new BOBBY balloon guide catheter. Christian Maegerlein who treated the patient with the BOBBY device commented, A severe stroke case with a left carotid occlusion was successfully treated with the use of the BOBBY, resulting in a first pass TICI 3, 20 minutes after groin puncture. The BOBBY balloon guide catheter is designed to aid in the insertion and guiding of an intravascular catheter into a specific blood artery in the peripheral and neurovascular systems. Dr. med. SOFIA Flow Plus 6F Aspiration Catheter Compatible, Optimized compatibility with SOFIA Flow Plus Aspiration Catheter1, The BOBBY Balloon Guide Catheter was tested with 6Fr OD compatible devices (2.13mm / 0.084in).1, Note: Guidewire not required for inflation of balloon. Christian Maegerlein who treated the patient with the BOBBY device commented, A severe stroke case with a left carotid occlusion was successfully treated with the use of the BOBBY, resulting in a first pass TICI 3, 20 minutes after groin puncture. Designed with ScepterMinis self-sealing purge valve to simplify and decrease balloon prep time. The majority of MicroVention's access products guide catheters, intermediate catheters, microcatheters, balloon catheters, and guidewires are specifically designed to work interchangeably across each of our product lines. Learn more about MicroVention's groundbreaking disease treatments. Proximal variable pitch braid reinforcement provides support and torque control, Hand shapeable distal tip allows for quick, easy tip shaping saving time and helping navigate challenging anatomy, The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. Recruiting. The device is not intended for use in coronary arteries. MicroVention president and CEO Carsten Schroeder said: The STRAIT trial is intended to provide clinical evidence that MicroVentions new balloon guide catheter can effectively contribute to improved clinical outcomes.. STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. Please consult the device Instruction For Use for more information. The guidewire can be steered to facilitate the selective. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Our access product portfolio enables physicians to gain access to the brain through a minimally invasive treatment called endovascular therapy.
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