Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 Embolization: Expanding Evidence and Awareness. 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 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. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. 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. 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. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Ist Patient Enrolled in Balloon-Guide Catheter Study The first BGC with a quick-prep system, and next-generation trackability. 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. REal-World Analyses of Stroke - ClinicalTrials.gov . Delivers atraumatic flow arrest without sacrificing aspiration power or time. Stryker Neurovascular | FlowGate Balloon Guide Catheter Moreover, 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 BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The Sofia catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. The balloon provides temporary vascular occlusion during these and other angiographic procedures. About TraxcessEX GuidewireThe Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Visit clinicaltrials.gov for more information. Microcatheters. Dr. med. The device is not intended for use in coronary arteries. 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. 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. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. The SOFIA Catheter is not intended for use in coronary arteries. MicroVention Announces First Patient Enrolled in the STRAIT Study with Find clinical trials, studies and registries involving this product. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. 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. Dr. med. 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. During these and other angiographic procedures, the balloon offers temporary vascular blockage. The SOFIACatheter can be used to facilitate introduction of diagnostic or therapeutic agents. ", 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.". FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. 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. 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. With stainless steel double braid and five transition zones. The SOFIACatheter is not intended for use in coronary arteries. The device is not intended for use in coronary arteries. Visit our contact page for information on how to place an order by phone, fax or email. A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter. 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 selectiveplacement of diagnostic or therapeutic catheters. Clinical Education. Learn more about MicroVention's groundbreaking disease treatments. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. 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. Dr. med. 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 device is not intended for use in coronary arteries. MicroVention Announces First Patient Enrolled in the STRAIT - Terumo Designed with ScepterMinis self-sealing purge valve to simplify and decrease balloon prep time. Please consult the device Instruction For Use for more information. It can be used to facilitate the introduction of diagnostic or therapeutic agents. Find clinical trials, studies and registries involving this product. MicroVention's goal is to be the leading global neuroendovascular company. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. The device is designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the companys Sofia Plus 6-F aspiration catheter. Recruiting. 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. 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.. About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Visit clinicaltrials.gov for more information. Find clinical trials, studies and registries involving this product. Published: April 28, 2023 at 9:22 p.m. Next Article 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.. . The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. This year, 80% of employees said its a great place to work 21 points higher than the average U.S.company. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. Dr. med. Learn more about MicroVention's groundbreaking disease treatments. This year, 80% of employees said its a great place to work 21 points higher than the average U.S. company. Our cutting-edge products lead the way in neuroendovascular therapies. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. ET. 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. Visit our contact page for information on how to place an order by phone, fax or email. placement of diagnostic or therapeutic catheters. Microvention, Mentice, GE Healthcare, and holds a licensing . Learn More. 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 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. 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. Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation [ Time Frame: During the procedure ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Online ahead of print. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. BOBBY | MicroVention Corporate Communication Dept., Terumo Corporation. MicroVention's STRAIT Study of the Bobby Balloon Guide Catheter Begins Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. 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. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. MicroVention begins subject enrolment in balloon guide catheter trial With a 10mm compliant balloon, designed to conform to the vessel wall. Dr. Maegerlein commented in MicroVentions press release, A severe stroke case with a left carotid occlusion was successfully treated with the use of the Bobby, resulting in a first pass TICI [thrombolysis in cerebral infarction] 3, 20 minutes after groin puncture. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). With the largest inner diameter of any 8F balloon guide catheter. BOBBY balloon guide catheter thrombectomy in large-vessel occlusion 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 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. from 8 AM - 9 PM ET. Balloon Occlusion Device Market Size is projected to Reach Multimillion USD by 2029, In comparison to 2022, at unexpected CAGR during the forecast Period . It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices. with the new Berenstein tip guide assist. MicroVention recruits first patient in STRAIT study of BOBBY catheter BOBBY | Microvention Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. A guidewire is a thin, flexible wire that is used to enter small and tortuous vessels to act as a guide for subsequent insertion of a another instrument such as a microcatheter or balloon catheter. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The guidewire can be steered to facilitate the selective. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. BOBBY Balloon Guide Catheter for Endovascular Treatment of | Clincosm Visit clinicaltrials.gov for more information. Learn more about MicroVention's groundbreaking disease treatments. STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. MicroVention Announces First Patient Enrolled in the STRAIT - BioSpace 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. Aneurysm Therapy Solutions, Ischemic Stroke & Carotid Artery Disease Solutions, Neurovascular Malformation Solutions, and Access Products. sofia 6f catheter: MICROVENTION, INC. K150366: 03/27/2015 sofia distal access catheter: MICROVENTION, INC. K142014: 10/10/2014 headway 17 advanced . The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease, Excellent torque transmission and maneuverability. 510(k) Premarket Notification Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. News Detail | Microvention Interventional Neuroradiology, Neurology and Neurosurgery. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. 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.. Access Product Solutions | MicroVention About Us | MicroVention ), Update your browser to view this website correctly. /PRNewswire/ -- MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a. MicroVention Announces First Patient. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. Read more Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. Expand All Quick-Prep Technology Designed with Scepter Mini's self-sealing purge valve to simplify and decrease balloon prep time. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. From there, the physician will deliver the treatment directly to the specified location through the catheter. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. 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) . The Bobby device is also indicated for use as a conduit for retrieval devices. For rapid neurovascular access with a balance of proximal support and distal flexibility. The SOFIA Catheter is not intended for use in coronary arteries. Looking for more information about this product? Copyright 2023 Terumo Corporation, All Rights Reserved. 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.
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