A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). Microvention, Mentice, GE Healthcare, and holds a licensing . Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. 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. . During these and other angiographic procedures, the balloon offers temporary vascular blockage. When typing in this field, a list of search results will appear and be automatically updated as you type. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. Dr. med. Embolization: Expanding Evidence and Awareness. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. 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 device is not intended for use in coronary arteries. View All Products Scepter C & Scepter XC Balloon Catheters 04 Microcatheters 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 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 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 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. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. The SOFIA-inspired, multiple transitions zones create a smooth, trackable, and stable experience. ", 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.". Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. 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 provides temporary vascular occlusion. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Created with Sketch. 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. For rapid neurovascular access with a balance of proximal support and distal flexibility. 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. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. 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. A microcatheter is a small diameter catheter that can be tracked over a guidewire in order to reach the target lesion. 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. With the largest inner diameter of any 8F balloon guide catheter. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. Indications may vary by region. Guidewires. The first BGC with a quick-prep system, and next-generation trackability. 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. Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. 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. Our access product portfolio enables physicians to gain access to the brain through a minimally invasive treatment called endovascular therapy. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). In 1997 MicroVention was founded and incorporated in a small facility in Southern California. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). right-arrow Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. placement of diagnostic or therapeutic catheters. Last January, MicroVentions WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA approval. Indications may vary by region. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. 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. Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. Please consult the device Instruction For Use for more information. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel (Uploaded on November 18, 2016. The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. Microcatheters. Ischemic Stroke and Carotid Artery Disease. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. . The device is not intended for use in coronary arteries. A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. 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 balloon provides temporary vascular occlusion during these and other angiographic procedures. The device is not intended for use in coronary arteries. Delivers atraumatic flow arrest without sacrificing aspiration power or time. 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. 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) . Dr. med. MicroVention develops a full range of access products, including catheters and guidewires, that allow physicians to gain access to the treatment area. The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Terumo will further strive to be of value to patients, medical professionals, and society at large. The SOFIA Catheter is not intended for use in coronary arteries. 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. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. . 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. First patient enrolled in the NAGOMI COMPLEX PMCF study. Find clinical trials, studies and registries involving this product. The Bobby device is also indicated for use as a conduit for retrieval devices. Copyright 2023 Terumo Corporation, All Rights Reserved. Dr. med. ET. 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 brain aneurysm is a weak, bulging spot on the wall of an artery. Custom coils in one week: Two years on from the launch of QwikCoil, whats next for Custom Wire Technologies? Ischemic Stroke and Carotid Artery Disease. 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 patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. Learn More. 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. Features and benefits Proximal flow control Our Story. Find clinical trials, studies and registries involving this product. Find clinical trials, studies and registries involving this product. The balloon provides temporary vascular occlusion during these and other angiographic procedures. We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. The device is not intended for use in coronary arteries. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 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. About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Come work alongside us in a rewarding and relaxed environment. All Rights Reserved Privacy Policy. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. Visit . . 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. 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. MM1331 NA 02/23 Last Updated . The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Coil Assist Stents. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. 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 SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. This diverse portfolio includes carotid stents, aspiration catheters, and mechanical thrombectomyproducts. Please consult the device Instruction For Use for more information. Access Product Solutions. Visit our contact page for information on how to place an order by phone, fax or email. Delivers atraumatic flow arrest without sacrificing aspiration power or time. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. 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. Ultimaster Nagomi MDR certification and launch of large-scale post-market study investigating the new coronary stent system in complex PCI, Terumo Groups Targets for Greenhouse Gas Reduction Approved by the SBT Initiative as 1.5C Aligned, Terumo Aortic Announces First Implant of Innovative Custom-made Thoracoabdominal Hybrid Device in North America, MicroVention Announces First Patient Enrolled in the STRAIT Study with the New BOBBY Balloon Guide Catheter. 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. Terumo will further strive to be of value to patients, medical professionals, and society at large. 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. Intermediate Catheters. 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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 intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. We set the bar high for ourselves and it wouldnt be possible without a collaborative work environment that values professional growth and innovation. 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. Soft Compliant Balloon It is also indicated for use as a conduit for retrieval devices. Published: April 28, 2023 at 9:22 p.m. 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. 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 currently approved in Europe and in North America. Plus, get our latest issues & supplements delivered to your inbox each month. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Expand All Quick-Prep Technology Designed with Scepter Mini's self-sealing purge valve to simplify and decrease balloon prep time. MicroVention is a neuroendovascular medical device company that develops minimally-invasive devices for treatment of vascular diseases in the brain. This year, 80% of employees said its a great place to work 21 points higher than the average U.S.company. sofia 6f catheter: MICROVENTION, INC. K150366: 03/27/2015 sofia distal access catheter: MICROVENTION, INC. K142014: 10/10/2014 headway 17 advanced . Terumos wholly-owned subsidiary MicroVention has announced the enrolment of the first participant in the STRAIT study of its new BOBBY balloon guide catheter. Dr. med. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. 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. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Find clinical trials, studies and registries involving this product. Read more In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. 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. 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. 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 guidewire can be steered to facilitate the selective. Terumo's acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. The device is not intended for use in coronary arteries. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Recruiting. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 Occlusion Balloon Catheters. 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. FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. We will accomplish this goal by producing the most reliable . The device is designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the companys Sofia Plus 6-F aspiration catheter. We provide a full range of catheter technologies for the treatment of several disease states. Wallaby Medical Acquires German Neurovascular Company Phenox GmbH, left-arrow 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. The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration 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 SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD.
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