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. Ischemic Stroke and Carotid Artery Disease. MicroVention is a neuroendovascular medical device company that develops minimally-invasive devices for treatment of vascular diseases in the brain. Find clinical trials, studies and registries involving this product. We will accomplish this goal by producing the most reliable . MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. MicroVention Announces First Patient Enrolled in the STRAIT Study with For rapid neurovascular access with a balance of proximal support and distal flexibility. It can be used to facilitate the introduction of diagnostic or therapeutic agents. 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. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. Dr. med. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease, Excellent torque transmission and maneuverability. 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.. Balloon Guide Catheters. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. . 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 balloon provides temporary vascular occlusion during these and other angiographic procedures. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Guidewires. We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. 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. MicroVention Announces First Patient Enrolled in the - SNISOnline 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. Terumo's acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. The SOFIA 6F catheter is compatible with guide or balloon guide catheters with an ID of 0.085" or larger. 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. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. The Sofia catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Learn more about MicroVention's groundbreaking disease treatments. Features and benefits Proximal flow control MicroVention's STRAIT Study of the Bobby Balloon Guide Catheter Begins It has been designed to assess the BOBBY balloon guide catheters safety and performance for endovascular treatment of acute ischemic stroke. 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. We took a novel approach by designing a ready-to-use liquid embolic device formalformations. It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. The SOFIA-inspired, multiple transitions zones create a smooth, trackable, and stable experience. The SOFIA Aspiration Catheter is designed for removing/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the neuro and peripheral vasculatures. The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Chaperon | Microvention Microcatheters. Looking for more information about this product? In 1997 MicroVention was founded and incorporated in a small facility in Southern California. Please consult the device Instruction For Use for more information. Access Product Solutions | MicroVention Access products allow doctors to gain access to the treatment area. Dr. med. Terumo will further strive to be of value to patients, medical professionals, and society at large. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. This year, 80% of employees said its a great place to work 21 points higher than the average U.S. company. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Indications may vary by region. 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. Note: Choose 8F (2.92mm / 0.115in) ID introducer sheath or larger. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. 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. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. All Rights Reserved Privacy Policy. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. 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. 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. Learn more about MicroVention's groundbreaking disease treatments. 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. SOFIA | Microvention Access Product Solutions. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. placement of diagnostic or therapeutic catheters. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. Home | MicroVention 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 Bobby device is also indicated for use as a conduit for retrieval devices. 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. Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. We provide a full range of catheter technologies for the treatment of several disease states. Created with Sketch. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel The SOFIACatheter can be used to facilitate introduction of diagnostic or therapeutic agents. The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. Latest "Balloon Occlusion Device Market" Highlights 2023 - MarketWatch The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. 510(k) Premarket Notification - Food and Drug Administration Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. When typing in this field, a list of search results will appear and be automatically updated as you type. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. Visit clinicaltrials.gov for more information. According to the company, the indications for these deviceswhich may vary by regioninclude the following: Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. MicroVention recruits first patient in STRAIT study of BOBBY catheter Delivers atraumatic flow arrest without sacrificing aspiration power or time. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. (Uploaded on November 18, 2016. With stainless steel double braid and five transition zones. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. 2023 Bryn Mawr Communications II, LLC. A catheter is a hollow, flexible tube inserted into a vessel to allow the passage of fluids or distend a passageway. 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. Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of 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 neuro vascular systems. About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. 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. An intermediate catheter is designed to help provide stability by reducing the tendency of the microcatheter to move during delivery/implantation of medical devices. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. 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. 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. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Balloon guide catheters: use, reject, or randomize? Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. Online ahead of print. right-arrow Visit clinicaltrials.gov for more information. 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 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. Occlusion Balloon Catheters. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. 510(k) Premarket Notification BOBBY Balloon Guide Catheter for Endovascular Treatment of | Clincosm Published: April 28, 2023 at 9:22 p.m. BOBBY balloon guide catheter thrombectomy in large-vessel occlusion stroke: Initial experience Interv Neuroradiol. 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. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. Intermediate Catheters. With the largest inner diameter of any 8F balloon guide catheter. The device is not intended for use in coronary arteries. The guidewire can be steered to facilitate the selective. 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 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 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. Learn more about MicroVention's groundbreaking disease treatments. 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. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. 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. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. . Soft Compliant Balloon ), Update your browser to view this website correctly. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. MicroVention Announces First Patient Enrolled in the STRAIT Study with Visit . 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. Aneurysm Therapy Solutions, Ischemic Stroke & Carotid Artery Disease Solutions, Neurovascular Malformation Solutions, and Access Products. A brain aneurysm is a weak, bulging spot on the wall of an artery. Visit our contact page for information on how to place an order by phone, fax or email. Plus, get our latest issues & supplements delivered to your inbox each month. 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 Corporate Communication Dept., Terumo Corporation. Learn more about MicroVention's groundbreaking disease treatments. Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. 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 device is not intended for use in coronary arteries. REal-World Analyses of Stroke - ClinicalTrials.gov It is also indicated for use as a conduit for retrieval devices. The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter. From there, the physician will deliver the treatment directly to the specified location through the catheter. 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. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. The SOFIA Catheter is not intended for use in coronary arteries. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. First patient enrolled in the NAGOMI COMPLEX PMCF study. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. The SOFIACatheter is not intended for use in coronary arteries. 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. 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. The first BGC with a quick-prep system, and next-generation trackability. The SOFIA Catheter is not intended for use in coronary arteries. 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. About TraxcessEX GuidewireThe Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. BOBBY | MicroVention BOBBY | MicroVention Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. 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. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. Our access product portfolio enables physicians to gain access to the brain through a minimally invasive treatment called endovascular therapy. Interventional Neuroradiology, Neurology and Neurosurgery. 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. Next Article The prestigious award is based entirely on what current employees say about their experience working at MicroVention. 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. Wallaby Medical Acquires German Neurovascular Company Phenox GmbH, left-arrow The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Coil Assist Stents. 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. 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. 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. Created with Sketch. It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices. 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. 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. A microcatheter is a small diameter catheter that can be tracked over a guidewire in order to reach the target lesion. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. Come work alongside us in a rewarding and relaxed environment. FlowGate Balloon Guide Catheter offers proximal flow control and a stable platform to facilitate the insertion and guidance of an intravascular catheter. BOBBY | Microvention Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. placement of diagnostic or therapeutic catheters. The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Dr. med. sofia 6f catheter: MICROVENTION, INC. K150366: 03/27/2015 sofia distal access catheter: MICROVENTION, INC. K142014: 10/10/2014 headway 17 advanced .