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. 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. placement of diagnostic or therapeutic catheters. FlowGate Balloon Guide Catheter offers proximal flow control and a stable platform to facilitate the insertion and guidance of an intravascular catheter. Features and benefits Proximal flow control 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. The SOFIACatheter is not intended for use in coronary arteries. 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. Occlusion Balloon Catheters. Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 The Traxcess 14 Guidewire is intended 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. 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. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease, Excellent torque transmission and maneuverability. Terumo will further strive to be of value to patients, medical professionals, and society at large. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. 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.. Interventional Neuroradiology, Neurology and Neurosurgery. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. 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. 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. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Learn More. Recruiting. 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. Come work alongside us in a rewarding and relaxed environment. 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. . About MicroVention, Inc.Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. 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. 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 first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. The study will evaluate the safety and performance of the new balloon guide catheter to treat acute ischemic stroke. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. 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. 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. Learn more about MicroVention's groundbreaking disease treatments. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. A microcatheter is a small diameter catheter that can be tracked over a guidewire in order to reach the target lesion. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. Delivers atraumatic flow arrest without sacrificing aspiration power or time. 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. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 ", 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.". It is also indicated for use as a conduit for retrieval devices. Plus, get our latest issues & supplements delivered to your inbox each month. We set the bar high for ourselves and it wouldnt be possible without a collaborative work environment that values professional growth and innovation. Learn more about MicroVention's groundbreaking disease treatments. 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. placement of diagnostic or therapeutic catheters. Clinical Education. The SOFIA 6F catheter is compatible with guide or balloon guide catheters with an ID of 0.085" or larger. 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. Created with Sketch. Visit . Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. Wallaby Medical Acquires German Neurovascular Company Phenox GmbH, left-arrow with the new Berenstein tip guide assist. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. 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. Our Story. 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. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel . The guidewire can be steered to facilitate the selective. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Ischemic Stroke and Carotid Artery Disease. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). Learn more about MicroVention's groundbreaking disease treatments. 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. This year, 80% of employees said its a great place to work 21 points higher than the average U.S.company. A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. Dr. med. The SOFIA Catheter is not intended for use in coronary arteries. With a 10mm compliant balloon, designed to conform to the vessel wall. The SOFIA Catheter is not intended for use in coronary arteries. The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Microvention, Mentice, GE Healthcare, and holds a licensing . 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 first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. 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. Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. 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. 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. 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. FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. Guide 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. 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 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. Visit our contact page for information on how to place an order by phone, fax or email. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. Delivers atraumatic flow arrest without sacrificing aspiration power or time. The Traxcess 14 guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Online ahead of print. Visit clinicaltrials.gov for more information. MicroVention develops a full range of access products, including catheters and guidewires, that allow physicians to gain access to the treatment area. MicroVention is a neuroendovascular medical device company that develops minimally-invasive devices for treatment of vascular diseases in the brain. Find clinical trials, studies and registries involving this product. 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. Access products allow doctors to gain access to the treatment area. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. It can be used to facilitate the introduction of diagnostic or therapeutic agents. ), Update your browser to view this website correctly. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. 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. For rapid neurovascular access with a balance of proximal support and distal flexibility. The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. 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. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. Custom coils in one week: Two years on from the launch of QwikCoil, whats next for Custom Wire Technologies? Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. . The guidewire can be steered to facilitate the selective. 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 advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. Coil Assist Stents. The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. 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. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. Visit clinicaltrials.gov for more information. from 8 AM - 9 PM ET. We took a novel approach by designing a ready-to-use liquid embolic device formalformations. 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. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. In 1997 MicroVention was founded and incorporated in a small facility in Southern California. Visit our contact page for information on how to place an order by phone, fax or email.
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