microvention balloon guide 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. sofia 6f catheter: MICROVENTION, INC. K150366: 03/27/2015 sofia distal access catheter: MICROVENTION, INC. K142014: 10/10/2014 headway 17 advanced . All Rights Reserved Privacy Policy. 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. Terumo's acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. 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. Note: Choose 8F (2.92mm / 0.115in) ID introducer sheath or larger. /PRNewswire/ -- MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a. MicroVention Announces First Patient. Access products allow doctors to gain access to the treatment area. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. Balloon Guide Catheters. A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). View All Products Scepter C & Scepter XC Balloon Catheters 04 Microcatheters Published: April 28, 2023 at 9:22 p.m. 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 balloon provides temporary vascular occlusion during these and other angiographic procedures. 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.. It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices. 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. 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. Plus, get our latest issues & supplements delivered to your inbox each month. Visit . Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 Expand All Quick-Prep Technology Designed with Scepter Mini's self-sealing purge valve to simplify and decrease balloon prep time. The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. Guidewires. 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.. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. 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. In 1997 MicroVention was founded and incorporated in a small facility in Southern California. ", 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.". ), Update your browser to view this website correctly. This year, 80% of employees said its a great place to work 21 points higher than the average U.S.company. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. A brain aneurysm is a weak, bulging spot on the wall of an artery. We took a novel approach by designing a ready-to-use liquid embolic device formalformations. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. Dr. med. Dr. med. 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. 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 The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. 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. Ischemic Stroke and Carotid Artery Disease. It is also indicated for use as a conduit for retrieval devices. . Features and benefits Proximal flow control The balloon provides temporary vascular occlusion during these and other angiographic procedures. Access Product Solutions. View or download the documents below for additional product resources. The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. Learn more about MicroVention's groundbreaking disease treatments. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Terumos wholly-owned subsidiary MicroVention has announced the enrolment of the first participant in the STRAIT study of its new BOBBY balloon guide catheter. placement of diagnostic or therapeutic catheters. 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. With a 10mm compliant balloon, designed to conform to the vessel wall. The device is not intended for use in coronary arteries. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. MicroVention develops a full range of access products, including catheters and guidewires, that allow physicians to gain access to the treatment area. 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.*. With stainless steel double braid and five transition zones. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Embolization: Expanding Evidence and Awareness. 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. 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. 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 neurovascular systems. Terumo will further strive to be of value to patients, medical professionals, and society at large. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel The balloon provides temporary vascular occlusion during these and other angiographic procedures. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The SOFIA Catheter is not intended for use in coronary arteries. The guidewire can be steered to facilitate the selective. 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. 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. . 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. 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 intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. 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Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. 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.

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