microvention balloon guide 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. It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices. 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.. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. 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. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). Visit our contact page for information on how to place an order by phone, fax or email. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. Balloon Guide Catheters. 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. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Our Story. with the new Berenstein tip guide assist. View All Products Scepter C & Scepter XC Balloon Catheters 04 Microcatheters Evaluation of the safety and performance of the BOBBY Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. 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. Access Product Solutions. 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 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. An intermediate catheter is designed to help provide stability by reducing the tendency of the microcatheter to move during delivery/implantation of medical devices. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. 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. Dr. med. It can be used to facilitate the introduction of diagnostic or therapeutic agents. FlowGate Balloon Guide Catheter offers proximal flow control and a stable platform to facilitate the insertion and guidance of an intravascular catheter. Created with Sketch. From there, the physician will deliver the treatment directly to the specified location through the catheter. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Delivers atraumatic flow arrest without sacrificing aspiration power or time. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. Terumo's acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. Find clinical trials, studies and registries involving this product. The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Looking for more information about this product? Dr. med. 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. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. Guidewires. 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. 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. Come work alongside us in a rewarding and relaxed environment. Corporate Communication Dept., Terumo Corporation. 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 indicated for general intravascular use, including the neuro and peripheral vasculature. BOBBY balloon guide catheter thrombectomy in large-vessel occlusion stroke: Initial experience Interv Neuroradiol. 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. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Dr. med. The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. sofia 6f catheter: MICROVENTION, INC. K150366: 03/27/2015 sofia distal access catheter: MICROVENTION, INC. K142014: 10/10/2014 headway 17 advanced . During these and other angiographic procedures, the balloon offers temporary vascular blockage. Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. 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. Terumo will further strive to be of value to patients, medical professionals, and society at large. Intermediate Catheters. Learn more about MicroVention's groundbreaking disease treatments. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. 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 catheter is a hollow, flexible tube inserted into a vessel to allow the passage of fluids or distend a passageway. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. With stainless steel double braid and five transition zones. Note: Choose 8F (2.92mm / 0.115in) ID introducer sheath or larger. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. 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. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease, Excellent torque transmission and maneuverability. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. The guidewire can be steered to facilitate the selective. All Rights Reserved Privacy Policy. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The device is designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the companys Sofia Plus 6-F aspiration catheter. 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. 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. 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. Last January, MicroVentions WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA approval. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. 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. Recruiting. View or download the documents below for additional product resources. Guide Catheters. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Dr. med. The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Read more 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. 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 designed to aid in the insertion and guiding of an intravascular catheter into a specific blood artery in the peripheral and neurovascular systems. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. The device is not intended for use in coronary arteries. Microvention, Mentice, GE Healthcare, and holds a licensing . Visit clinicaltrials.gov for more information. 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. ", 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.". 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. 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. Access products allow doctors to gain access to the treatment area. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. 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. Visit clinicaltrials.gov for more information. 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 deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. 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. 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. The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. ET. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Interventional Neuroradiology, Neurology and Neurosurgery. Visit our contact page for information on how to place an order by phone, fax or email. The device 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. Endovascular procedures offer many advantages, including a shorter recovery period, less discomfort, a small incision, and fewer risks for patients that have other medical conditions.*. It is also indicated for use as a conduit for retrieval devices. . 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. 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.. 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. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. Find clinical trials, studies and registries involving this product. 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 balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. 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. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). 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. Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. Clinical Education. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. from 8 AM - 9 PM ET. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. 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 Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. 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. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. Please consult the device Instruction For Use for more information. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. ), Update your browser to view this website correctly. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 Aneurysm Therapy Solutions, Ischemic Stroke & Carotid Artery Disease Solutions, Neurovascular Malformation Solutions, and Access Products. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel 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. Learn more about MicroVention's groundbreaking disease treatments. Wallaby Medical Acquires German Neurovascular Company Phenox GmbH, left-arrow Plus, get our latest issues & supplements delivered to your inbox each month. This year, 80% of employees said its a great place to work 21 points higher than the average U.S.company. MicroVention is a neuroendovascular medical device company that develops minimally-invasive devices for treatment of vascular diseases in the brain. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. In 1997 MicroVention was founded and incorporated in a small facility in Southern California. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). Ischemic Stroke and Carotid Artery Disease. Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. 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. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. 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 first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. 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. Exceptionally soft distal segment allows forexcellent navigability and trackability into distal anatomy, enabling the SOFIA Catheter to provide support close to the treatment site, Hybrid Braid and Coil Design provides 1:1 push/pull control for enhanced trackability. 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. 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MicroVention develops a full range of access products, including catheters and guidewires, that allow physicians to gain access to the treatment area. /PRNewswire/ -- MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a. MicroVention Announces First Patient. The first BGC with a quick-prep system, and next-generation trackability. 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. 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. We will accomplish this goal by producing the most reliable . 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. Published: April 28, 2023 at 9:22 p.m. Created with Sketch. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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.

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