It has been designed to assess the BOBBY balloon guide catheters safety and performance for endovascular treatment of acute ischemic stroke. 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. It is also indicated for use as a conduit for retrieval devices. Online ahead of print. from 8 AM - 9 PM ET. 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. 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. View or download the documents below for additional product resources. The SOFIA Catheter is not intended for use in coronary arteries. Visit clinicaltrials.gov for more information. Visit clinicaltrials.gov for more information. A catheter is a hollow, flexible tube inserted into a vessel to allow the passage of fluids or distend a passageway. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The SOFIA 6F catheter is compatible with guide or balloon guide catheters with an ID of 0.085" or larger. Find clinical trials, studies and registries involving this product. The SOFIA-inspired, multiple transitions zones create a smooth, trackable, and stable experience. 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. 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. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Visit . 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. ), 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, 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. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. Visit clinicaltrials.gov for more information. 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. 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. BOBBY | MicroVention It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. Created with Sketch. The SOFIA Catheter is not intended for use in coronary arteries. 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. For rapid neurovascular access with a balance of proximal support and distal flexibility. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. Recruiting. STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. Safety and Performance of the BOBBY Balloon Guide Catheter 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. 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. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Dr. med. MicroVention Announces First Patient Enrolled in the STRAIT - BioSpace The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. (Uploaded on November 18, 2016. 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. BOBBY balloon guide catheter thrombectomy in large-vessel occlusion Microvention, Mentice, GE Healthcare, and holds a licensing . 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. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Learn More. 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. The guidewire can be steered to facilitate the selective. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. 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. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. Visit our contact page for information on how to place an order by phone, fax or email. We will accomplish this goal by producing the most reliable . Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. 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. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. 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 Chaperon | Microvention Terumos wholly-owned subsidiary MicroVention has announced the enrolment of the first participant in the STRAIT study of its new BOBBY balloon guide catheter. Designed with ScepterMinis self-sealing purge valve to simplify and decrease balloon prep time. 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. During these and other angiographic procedures, the balloon offers temporary vascular blockage. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Occlusion Balloon Catheters. 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. Dr. med. MicroVention president and CEO Carsten Schroeder said: The STRAIT trial is intended to provide clinical evidence that MicroVentions new balloon guide catheter can effectively contribute to improved clinical outcomes.. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. Indications may vary by region. 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. View All Products Scepter C & Scepter XC Balloon Catheters 04 Microcatheters Expand All Quick-Prep Technology Designed with Scepter Mini's self-sealing purge valve to simplify and decrease balloon prep time. Last January, MicroVentions WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA approval. Learn more about MicroVention's groundbreaking disease treatments. In 1997 MicroVention was founded and incorporated in a small facility in Southern California. Dr. med. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. MicroVention Announces First Patient Enrolled in the - SNISOnline We took a novel approach by designing a ready-to-use liquid embolic device formalformations. The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. Dr. med. 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. 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. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. ET. placement of diagnostic or therapeutic catheters. Guide Catheters. The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). Intermediate Catheters. Previous Article, Terumo Aortics Thoraflex Hybrid Device Approved by FDA for Complex Aortic Arch Disease Repair. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Indications may vary by region. BOBBY balloon guide catheter thrombectomy in large-vessel occlusion stroke: Initial experience Interv Neuroradiol. MicroVention develops a full range of access products, including catheters and guidewires, that allow physicians to gain access to the treatment area. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. Aliso Viejo, California andAlajuela, Costa Rica, April 11, 2023 MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today hosted the Republic of Costa Ricas President Rodrigo Chaves Robles and other government officials and dignitaries at its Costa Rica facility inAlajuela. 2023 Bryn Mawr Communications II, LLC. Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter. The SOFIACatheter can be used to facilitate introduction of diagnostic or therapeutic agents. Delivers atraumatic flow arrest without sacrificing aspiration power or time. Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 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. First patient enrolled in the NAGOMI COMPLEX PMCF study. We provide a full range of catheter technologies for the treatment of several disease states. About TraxcessEX GuidewireThe Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Looking for more information about this product? Coil Assist Stents. 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. Ischemic Stroke and Carotid Artery Disease. MicroVention recruits first patient in STRAIT study of BOBBY catheter Balloon guide catheters: use, reject, or randomize? From there, the physician will deliver the treatment directly to the specified location through the catheter. Balloon Guide Catheters. 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. Access Product Solutions. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. 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 balloon provides temporary vascular occlusion during these and other angiographic procedures. Next Article 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. Find clinical trials, studies and registries involving this product. Our access product portfolio enables physicians to gain access to the brain through a minimally invasive treatment called endovascular therapy. 510(k) Premarket Notification - Food and Drug Administration Clinical Education. MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. With the largest inner diameter of any 8F balloon guide catheter. Terumo will further strive to be of value to patients, medical professionals, and society at large. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Terumo's acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. 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) . The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. 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. . News Detail | Microvention Home | MicroVention Find clinical trials, studies and registries involving this product. The Sofia catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. 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 device is not intended for use in coronary arteries. 510(k) Premarket Notification The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. The device is not intended for use in coronary arteries. Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. Visit our contact page for information on how to place an order by phone, fax or email. 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. BOBBY | 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. Ischemic Stroke and Carotid Artery Disease. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). MicroVention Announces First Patient Enrolled in the STRAIT Study with It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Terumo will further strive to be of value to patients, medical professionals, and society at large. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. Delivers atraumatic flow arrest without sacrificing aspiration power or time. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. When typing in this field, a list of search results will appear and be automatically updated as you type. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease, Excellent torque transmission and maneuverability. 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. 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. with the new Berenstein tip guide assist. Find clinical trials, studies and registries involving this product. Come work alongside us in a rewarding and relaxed environment. 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. 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. Ist Patient Enrolled in Balloon-Guide Catheter Study It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. The first BGC with a quick-prep system, and next-generation trackability. Learn More. A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. 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