Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Access products allow doctors to gain access to the treatment area. 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.. Come work alongside us in a rewarding and relaxed environment. The first BGC with a quick-prep system, and next-generation trackability.
MicroVention Announces First Patient Enrolled in the STRAIT - Terumo MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. Copyright 2023 Terumo Corporation, All Rights Reserved. Indications may vary by region. Dr. med. Visit our contact page for information on how to place an order by phone, fax or email. Terumos wholly-owned subsidiary MicroVention has announced the enrolment of the first participant in the STRAIT study of its new BOBBY balloon guide catheter. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
News Detail | Microvention Intermediate Catheters. Delivers atraumatic flow arrest without sacrificing aspiration power or time. Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. View or download the documents below for additional product resources. The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. 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. 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 Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature.
REal-World Analyses of Stroke - ClinicalTrials.gov 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 device is not intended for use in coronary arteries. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. 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 SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. Occlusion Balloon Catheters. 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. 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. Visit clinicaltrials.gov for more information. The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. Find clinical trials, studies and registries involving this product. From there, the physician will deliver the treatment directly to the specified location through the catheter. Terumo will further strive to be of value to patients, medical professionals, and society at large. It can be used to facilitate the introduction of diagnostic or therapeutic agents. Learn more about MicroVention's groundbreaking disease treatments. Please consult the device Instruction For Use for more information. Last January, MicroVentions WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA approval. 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. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. . 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. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. 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 company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. 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. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. 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. Learn More. Indications may vary by region. 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. With the largest inner diameter of any 8F balloon guide catheter.
MicroVention recruits first patient in STRAIT study of BOBBY catheter The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Recruiting. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. 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. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. 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. Dr. med. 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. MM1331 NA 02/23 Last Updated .
510(k) Premarket Notification - Food and Drug Administration When typing in this field, a list of search results will appear and be automatically updated as you type. ), Update your browser to view this website correctly. 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. Visit our contact page for information on how to place an order by phone, fax or email. Microvention, Mentice, GE Healthcare, and holds a licensing . Online ahead of print. 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 WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. 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. . 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. (Uploaded on November 18, 2016. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. . 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. 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. Features and benefits Proximal flow control 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. We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. 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. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years.
Chaperon | Microvention SOFIA | Microvention The balloon provides temporary vascular occlusion during these and other angiographic procedures. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. 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. Wallaby Medical Acquires German Neurovascular Company Phenox GmbH, left-arrow