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510(k) Premarket Notification - Food and Drug Administration MicroVention's goal is to be the leading global neuroendovascular company. Terumo's acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The first BGC with a quick-prep system, and next-generation trackability. We provide a full range of catheter technologies for the treatment of several disease states. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. 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. In 1997 MicroVention was founded and incorporated in a small facility in Southern California. All Rights Reserved Privacy Policy. (Uploaded on November 18, 2016. 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) . 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. Please consult the device Instruction For Use for more information. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. 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. Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. Coil Assist Stents. Once the blood vessels are accessed, a catheter is typically inserted through this small incision and guided to the location of the brain where treatment is necessary. ALISO VIEJO, Calif., April 20, 2022 /PRNewswire/ -- 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 Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Learn More. We took a novel approach by designing a ready-to-use liquid embolic device formalformations. 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. About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. Occlusion Balloon Catheters. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. 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 SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. MicroVention Announces First Patient Enrolled in the STRAIT - BioSpace Soft Compliant Balloon Find clinical trials, studies and registries involving this product. . placement of diagnostic or therapeutic catheters. 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 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. SOFIA | Microvention The balloon provides temporary vascular occlusion during these and other angiographic procedures. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. Learn more about MicroVention's groundbreaking disease treatments. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter. The SOFIA-inspired, multiple transitions zones create a smooth, trackable, and stable experience. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. 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. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Chaperon | Microvention We were pleased with the excellent performance of the Bobby balloon guide catheter with the Sofia Plus 6-F aspiration catheter, Headway microcatheter, Traxcess EX guidewire, and the 6 X 40 stent retriever revascularization device.. BOBBY Balloon Guide Catheter for Endovascular Treatment of | Clincosm It has been designed to assess the BOBBY balloon guide catheters safety and performance for endovascular treatment of acute ischemic stroke. 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. 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. About TraxcessEX GuidewireThe Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Created with Sketch. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Indications may vary by region. right-arrow ), Update your browser to view this website correctly. 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. 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.*. REal-World Analyses of Stroke - ClinicalTrials.gov A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. Delivers atraumatic flow arrest without sacrificing aspiration power or time. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Recruiting. Find clinical trials, studies and registries involving this product. 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. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Dr. med. Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 Visit clinicaltrials.gov for more information. 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. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. ALISO VIEJO, Calif., April 20, 2022 /PRNewswire/ -- 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. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). 2023 Bryn Mawr Communications II, LLC. Read more The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. Home | MicroVention About the BOBBY Balloon Guide CatheterThe 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. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. 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. Access Product Solutions. Exceptionally soft distal segment allows forexcellent navigability and trackability into distal anatomy, enabling the SOFIA Catheter to provide support close to the treatment site, Hybrid Braid and Coil Design provides 1:1 push/pull control for enhanced trackability. We set the bar high for ourselves and it wouldnt be possible without a collaborative work environment that values professional growth and innovation. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Visit clinicaltrials.gov for more information. We will accomplish this goal by producing the most reliable . The Bobby device is also indicated for use as a conduit for retrieval devices. 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. 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. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. The device is not intended for use in coronary arteries. 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. FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. The SOFIA 6F catheter is compatible with guide or balloon guide catheters with an ID of 0.085" or larger. BOBBY balloon guide catheter thrombectomy in large-vessel occlusion The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The device is not intended for use in coronary arteries. 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. Terumo will further strive to be of value to patients, medical professionals, and society at large. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. 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. Guide Catheters. The guidewire can be steered to facilitate the selective. www.microvention.com, About Terumo CorporationTerumo (TSE: 4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. 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. The balloon provides temporary vascular occlusion during these and other angiographic procedures. About the Headway MicrocatheterThe 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. Stryker Neurovascular | FlowGate Balloon Guide Catheter A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). When typing in this field, a list of search results will appear and be automatically updated as you type. from 8 AM - 9 PM ET. 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. Delivers atraumatic flow arrest without sacrificing aspiration power or time. Ischemic Stroke and Carotid Artery Disease. Learn more about MicroVention's groundbreaking disease treatments. 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. Visit our contact page for information on how to place an order by phone, fax or email.