microvention balloon guide catheter

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) . 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. Dr. med. The Traxcess 14 guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Interventional Neuroradiology, Neurology and Neurosurgery. Please consult the device Instruction For Use for more information. A brain aneurysm is a weak, bulging spot on the wall of an artery. Embolization: Expanding Evidence and Awareness. View or download the documents below for additional product resources. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. 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. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. Read more FlowGate Balloon Guide Catheter offers proximal flow control and a stable platform to facilitate the insertion and guidance of an intravascular catheter. Please consult the device Instruction For Use for more information. Learn more about MicroVention's groundbreaking disease treatments. 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. ), Update your browser to view this website correctly. It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. The device is not intended for use in coronary arteries. 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. For rapid neurovascular access with a balance of proximal support and distal flexibility. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. This year, 80% of employees said its a great place to work 21 points higher than the average U.S. company. Plus, get our latest issues & supplements delivered to your inbox each month. ", 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.". 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. We will accomplish this goal by producing the most reliable . 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 Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. The device is not intended for use in coronary arteries. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 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. Published: April 28, 2023 at 9:22 p.m. The SOFIACatheter is not intended for use in coronary arteries. Created with Sketch. /PRNewswire/ -- MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a. MicroVention Announces First Patient. With stainless steel double braid and five transition zones. 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. 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. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. Access products allow doctors to gain access to the treatment area. The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. 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. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Online ahead of print. Terumo will further strive to be of value to patients, medical professionals, and society at large. Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. 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. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. 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 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. Indications may vary by region. Find clinical trials, studies and registries involving this product. . 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. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. 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 selectiveplacement of diagnostic or therapeutic catheters. View All Products Scepter C & Scepter XC Balloon Catheters 04 Microcatheters The device is not intended for use in coronary arteries. 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. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. The balloon provides temporary vascular occlusion during these and other angiographic procedures. From there, the physician will deliver the treatment directly to the specified location through the catheter. It provides a balance of trackability and support with a large lumen and is 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. 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. A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Looking for more information about this product? A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). 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. (Uploaded on November 18, 2016. Note: Choose 8F (2.92mm / 0.115in) ID introducer sheath or larger. Terumo will further strive to be of value to patients, medical professionals, and society at large. We set the bar high for ourselves and it wouldnt be possible without a collaborative work environment that values professional growth and innovation. The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. The SOFIA 6F catheter is compatible with guide or balloon guide catheters with an ID of 0.085" or larger. 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. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. Find clinical trials, studies and registries involving this product. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. Visit clinicaltrials.gov for more information. Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. 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. STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Coil Assist Stents. 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 balloon provides temporary vascular occlusion during these and other angiographic procedures. We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. 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. 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 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. 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. 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. 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. placement of diagnostic or therapeutic catheters. The SOFIACatheter can be used to facilitate introduction of diagnostic or therapeutic agents. Come work alongside us in a rewarding and relaxed environment. . Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). 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. Learn more about MicroVention's groundbreaking disease treatments. 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. Visit our contact page for information on how to place an order by phone, fax or email. 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. It is also indicated for use as a conduit for retrieval devices. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. 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. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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.

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