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.. Guide Catheters. Please consult the device Instruction For Use for more information. 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. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. The first BGC with a quick-prep system, and next-generation trackability. 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. 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. Our Story. 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. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Intermediate Catheters. The device is not intended for use in coronary arteries. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. 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. Soft Compliant Balloon Visit our contact page for information on how to place an order by phone, fax or email. Custom coils in one week: Two years on from the launch of QwikCoil, whats next for Custom Wire Technologies? The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. Created with Sketch. 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 prestigious award is based entirely on what current employees say about their experience working at MicroVention. MicroVention's goal is to be the leading global neuroendovascular company. We will accomplish this goal by producing the most reliable . A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. Learn More. Find clinical trials, studies and registries involving this product. Delivers atraumatic flow arrest without sacrificing aspiration power or time. 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. Learn more about MicroVention's groundbreaking disease treatments. 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. The device is not intended for use in coronary arteries. Access products allow doctors to gain access to the treatment area. 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. About TraxcessEX GuidewireThe Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Designed with ScepterMinis self-sealing purge valve to simplify and decrease balloon prep time. 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 BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. Delivers atraumatic flow arrest without sacrificing aspiration power or time. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). 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.. Learn more about MicroVention's groundbreaking disease treatments. Terumo's 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. From there, the physician will deliver the treatment directly to the specified location through the catheter. ), Update your browser to view this website correctly. Visit our contact page for information on how to place an order by phone, fax or email. It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices. 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. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Guidewires. Next Article Dr. med. An intermediate catheter is designed to help provide stability by reducing the tendency of the microcatheter to move during delivery/implantation of medical devices. About the SOFIA Aspiration CatheterThe 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. 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. 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. STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. FlowGate Balloon Guide Catheter offers proximal flow control and a stable platform to facilitate the insertion and guidance of an intravascular catheter. placement of diagnostic or therapeutic catheters. First patient enrolled in the NAGOMI COMPLEX PMCF study. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. The balloon provides temporary vascular occlusion during these and other angiographic procedures. . 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 SOFIA-inspired, multiple transitions zones create a smooth, trackable, and stable experience. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. During these and other angiographic procedures, the balloon offers temporary vascular blockage. 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. We set the bar high for ourselves and it wouldnt be possible without a collaborative work environment that values professional growth and innovation. 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. 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. Please consult the device Instruction For Use for more information. 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.. 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. 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 balloon provides temporary vascular occlusion during these and other angiographic procedures. 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 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. 2023 Bryn Mawr Communications II, LLC. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. 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. Visit our contact page for information on how to place an order by phone, fax or email. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. 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. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. 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. Balloon Occlusion Device Market Size is projected to Reach Multimillion USD by 2029, In comparison to 2022, at unexpected CAGR during the forecast Period . 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. Recruiting. The leading site for news and procurement in the medical device industry, Nanotech knowledge grows to progress tuberculosis treatment, Sterilisation innovation to prioritise patient safety, Transcatheter accessories becoming more specialised, MedShift receives $45m loan from Turning Rock, TeraRecon launches new AI-powered Neuro Suite platform, Nuvo Group signs LOI to combine with SPAC to go public, Twinn.health introduces AI-based imaging platform for age-related diseases, FDA grants Ultromics EchoGo Amyloidosis platform breakthrough device status, Medtronic reports increase in Q3 2023 global revenue, BD reports 2.8% decline in Q1 2023 revenues, The six crucial advantages of Software as a Service for eIFU. 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. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. ET. 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. Ischemic Stroke and Carotid Artery Disease. Coil Assist Stents. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. 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. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Indications may vary by region. Access Product Solutions. Learn More. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. 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. 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. Learn more about MicroVention's groundbreaking disease treatments. The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. (Uploaded on November 18, 2016.

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