Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel ), Update your browser to view this website correctly. 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. Corporate Communication Dept., Terumo Corporation. Read more Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. Ischemic Stroke and Carotid Artery Disease. 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. Please consult the device Instruction For Use for more information. All Rights Reserved Privacy Policy. Created with Sketch. We will accomplish this goal by producing the most reliable . The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. 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. Access products allow doctors to gain access to the treatment area. 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. with the new Berenstein tip guide assist. Created with Sketch. We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. Aneurysm Therapy Solutions, Ischemic Stroke & Carotid Artery Disease Solutions, Neurovascular Malformation Solutions, and Access Products. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. 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 SOFIA 6F catheter is compatible with guide or balloon guide catheters with an ID of 0.085" or larger. The balloon provides temporary vascular occlusion during these and other angiographic procedures. From there, the physician will deliver the treatment directly to the specified location through the 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. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. right-arrow Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 Visit our contact page for information on how to place an order by phone, fax or email. Visit our contact page for information on how to place an order by phone, fax or email. Indications may vary by region. Learn more about MicroVention's groundbreaking disease treatments. . The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. from 8 AM - 9 PM ET. When typing in this field, a list of search results will appear and be automatically updated as you type. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. The SOFIA Catheter is not intended for use in coronary arteries. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. 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. Our cutting-edge products lead the way in neuroendovascular therapies. Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. 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 neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. 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. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. 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. Learn more about MicroVention's groundbreaking disease treatments. 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. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). Find clinical trials, studies and registries involving this product. Visit . 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 About TraxcessEX GuidewireThe Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Soft Compliant Balloon 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. 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. Guide Catheters. 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. Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. Ischemic Stroke and Carotid Artery Disease. Come work alongside us in a rewarding and relaxed environment. About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). Our Story. The SOFIACatheter is not intended for use in coronary arteries. 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 BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. 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. STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. 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. Find clinical trials, studies and registries involving this product. Learn more about MicroVention's groundbreaking disease treatments. Interventional Neuroradiology, Neurology and Neurosurgery. . We set the bar high for ourselves and it wouldnt be possible without a collaborative work environment that values professional growth and innovation. 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. The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. Moreover, the SOFIACatheter 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. Find clinical trials, studies and registries involving this product. With the largest inner diameter of any 8F balloon guide catheter. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. Find clinical trials, studies and registries involving this product. 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.
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