STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. The device is not intended for use in coronary arteries. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition. 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. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. BOBBY | MicroVention FlowGate Balloon Guide Catheter offers proximal flow control and a stable platform to facilitate the insertion and guidance of an intravascular catheter. Visit clinicaltrials.gov for more information. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. 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 SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease, Excellent torque transmission and maneuverability. Learn more about MicroVention's groundbreaking disease treatments. MicroVention Announces First Patient Enrolled in the STRAIT - BioSpace The balloon provides temporary vascular occlusion during these and other angiographic procedures. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). from 8 AM - 9 PM ET. It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices. The guidewire can be steered to facilitate the selective. The Traxcess 14 guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Update my browser now. Coil Assist Stents. Copyright 2023 Terumo Corporation, All Rights Reserved. With the largest inner diameter of any 8F balloon guide catheter. The guidewire can be steered to facilitate the selective. Soft Compliant Balloon 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. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. For rapid neurovascular access with a balance of proximal support and distal flexibility. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. Please consult the device Instruction For Use for more information. An intermediate catheter is designed to help provide stability by reducing the tendency of the microcatheter to move during delivery/implantation of medical devices. This diverse portfolio includes carotid stents, aspiration catheters, and mechanical thrombectomyproducts. 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. Plus, get our latest issues & supplements delivered to your inbox each month. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. Balloon Occlusion Device Market Size is projected to Reach Multimillion USD by 2029, In comparison to 2022, at unexpected CAGR during the forecast Period . 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. ET. 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. Our focus is to provide ideal, integrated comprehensive solutions, easy-to-use products, and proven best practices to fulfill our customers needs from start to finish. Expand All Quick-Prep Technology Designed with Scepter Mini's self-sealing purge valve to simplify and decrease balloon prep time. Balloon guide catheters: use, reject, or randomize? with the new Berenstein tip guide assist. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Custom coils in one week: Two years on from the launch of QwikCoil, whats next for Custom Wire Technologies? MicroVention Announces First Patient Enrolled in the STRAIT Study with Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Dr. med. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. 510(k) Premarket Notification - Food and Drug Administration REal-World Analyses of Stroke - ClinicalTrials.gov Stryker Neurovascular | FlowGate Balloon Guide Catheter Our cutting-edge products lead the way in neuroendovascular therapies. Ist Patient Enrolled in Balloon-Guide Catheter Study Intermediate Catheters. MicroVention develops a full range of access products, including catheters and guidewires, that allow physicians to gain access to the treatment area. 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 device is not intended for use in coronary arteries. 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.. Online ahead of print. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. 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. MicroVention's goal is to be the leading global neuroendovascular company. Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. 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. A brain aneurysm is a weak, bulging spot on the wall of an artery. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. Learn more about MicroVention's groundbreaking disease treatments. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Access Product Solutions | MicroVention Home | MicroVention A catheter is a hollow, flexible tube inserted into a vessel to allow the passage of fluids or distend a passageway. Created with Sketch. The device is not intended for use in coronary arteries. Terumos wholly-owned subsidiary MicroVention has announced the enrolment of the first participant in the STRAIT study of its new BOBBY balloon guide catheter. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. All Rights Reserved Privacy Policy. BOBBY Balloon Guide Catheter for Endovascular Treatment of | Clincosm 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. It is also indicated for use as a conduit for retrieval devices. Come work alongside us in a rewarding and relaxed environment. The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. Terumo's acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. MicroVention's STRAIT Study of the Bobby Balloon Guide Catheter Begins Delivers atraumatic flow arrest without sacrificing aspiration power or time. Chaperon | Microvention Visit clinicaltrials.gov for more information. The device is designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the companys Sofia Plus 6-F aspiration catheter. Guiding Catheters Product Benefits Integrated guiding catheter system offering support and a large inner diameter lumen, featuring a unique inner catheter option for rapid atraumatic access Expand All Large 6F Catheter ID Allows for Multiple Catheter Usage Thin PTFE layer and flat wire braid creates increased lumen diameter MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. Dr. med. 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. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. Visit . MM1331 NA 02/23 Last Updated . Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. . Learn More. Embolization: Expanding Evidence and Awareness. Please consult the device Instruction For Use for more information. 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). Balloon Guide Catheters. Delivers atraumatic flow arrest without sacrificing aspiration power or time. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). The first BGC with a quick-prep system, and next-generation trackability. With a 10mm compliant balloon, designed to conform to the vessel wall. /PRNewswire/ -- MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a. MicroVention Announces First Patient. BOBBY | Microvention This year, 80% of employees said its a great place to work 21 points higher than the average U.S.company. It has been designed to assess the BOBBY balloon guide catheters safety and performance for endovascular treatment of acute ischemic stroke. Published: April 28, 2023 at 9:22 p.m. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. The Bobby device is also indicated for use as a conduit for retrieval devices. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. 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. Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. Endovascular Today (ISSN 1551-1944 print and ISSN 2689-792X online) is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 In 1997 MicroVention was founded and incorporated in a small facility in Southern California. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. Created with Sketch. 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 SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. 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. Microcatheters. 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. 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. We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. . Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. Visit our contact page for information on how to place an order by phone, fax or email. ", 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.". The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. We took a novel approach by designing a ready-to-use liquid embolic device formalformations. The balloon provides temporary vascular occlusion during these and other angiographic procedures. We provide a full range of catheter technologies for the treatment of several disease states. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. 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. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Aneurysm Therapy Solutions, Ischemic Stroke & Carotid Artery Disease Solutions, Neurovascular Malformation Solutions, and Access Products. With stainless steel double braid and five transition zones. Visit clinicaltrials.gov for more information. 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. 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. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. About Us | MicroVention The SOFIA-inspired, multiple transitions zones create a smooth, trackable, and stable experience. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. Dr. med. The SOFIACatheter is not intended for use in coronary arteries. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. TIS Division (Terumo Interventional Systems), Cardiovascular Division (Terumo Cardiovascular)/ HeartSheet Division, Terumo Blood and Cell Technologies Company (Terumo Blood and Cell Technologies), Creating a Diverse and Inclusive Workplace. Terumo will further strive to be of value to patients, medical professionals, and society at large. Learn more about MicroVention's groundbreaking disease treatments. Designed with ScepterMinis self-sealing purge valve to simplify and decrease balloon prep time. Features and benefits Proximal flow control The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Last January, MicroVentions WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA approval. 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 Sofia catheter 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. 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. 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. placement of diagnostic or therapeutic catheters. It can be used to facilitate the introduction of diagnostic or therapeutic agents. placement of diagnostic or therapeutic catheters. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility.