Balloon Guide Catheters Product Benefits The first BGC with a quick-prep system, and next-generation trackability. It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. The guidewire can be steered to facilitate the selective. With stainless steel double braid and five transition zones. The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. With a 10mm compliant balloon, designed to conform to the vessel wall. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. The balloon provides temporary vascular occlusion during these and other angiographic procedures. MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. Read more During these and other angiographic procedures, the balloon offers temporary vascular blockage. Access Product Solutions. Please consult the device Instruction For Use for more information. Find clinical trials, studies and registries involving this product. Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. The guidewire can be steered to facilitate the selectiveplacement of diagnostic or therapeutic catheters. placement of diagnostic or therapeutic catheters. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. 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. 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. Published: April 28, 2023 at 9:22 p.m. In 1997 MicroVention was founded and incorporated in a small facility in Southern California. . During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. 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. Director, Corporate CommunicationsMicroVention, Inc.+1-714-247-8000, Cision Distribution 888-776-0942 Learn more about MicroVention's groundbreaking disease treatments. Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. . 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. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. Designed with ScepterMinis self-sealing purge valve to simplify and decrease balloon prep time. The SOFIACatheter is not intended for use in coronary arteries. 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 company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. 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. ), Update your browser to view this website correctly. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. 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 device is designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the companys Sofia Plus 6-F aspiration catheter. Dual lumen reinforcement provides fast, consistent balloon inflation and deflation. 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. sofia 6f catheter: MICROVENTION, INC. K150366: 03/27/2015 sofia distal access catheter: MICROVENTION, INC. K142014: 10/10/2014 headway 17 advanced . Ischemic Stroke and Carotid Artery Disease. All Rights Reserved Privacy Policy. 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. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. 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. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel The device is not intended for use in coronary arteries. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. 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. 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. 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. A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). 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. 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. . FlowGate Balloon Guide Catheter offers proximal flow control and a stable platform to facilitate the insertion and guidance of an intravascular catheter. BOBBY balloon guide catheter thrombectomy in large-vessel occlusion stroke: Initial experience Interv Neuroradiol. 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. The device is not intended for use in coronary arteries. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. with the new Berenstein tip guide assist. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. Visit our contact page for information on how to place an order by phone, fax or email. Intermediate Catheters. A catheter is a hollow, flexible tube inserted into a vessel to allow the passage of fluids or distend a passageway. ", 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.". 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. 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. Dr. med. 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. Last January, MicroVentions WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA approval. 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. 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. 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. 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. 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. Ischemic Stroke and Carotid Artery Disease. Learn more about MicroVention's groundbreaking disease treatments. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). The device is not intended for use in coronary arteries. 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. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. Terumo will further strive to be of value to patients, medical professionals, and society at large. Balloon Occlusion Device Market Size is projected to Reach Multimillion USD by 2029, In comparison to 2022, at unexpected CAGR during the forecast Period . Learn More. Please consult the device Instruction For Use for more information. Our focus is to provide ideal, integrated comprehensive solutions, easy-to-use products, and proven best practices to fulfill our customers needs from start to finish. 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. Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. 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. 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. 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. Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. ET. It has been designed to assess the BOBBY balloon guide catheters safety and performance for endovascular treatment of acute ischemic stroke. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. View All Products Scepter C & Scepter XC Balloon Catheters 04 Microcatheters 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. The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 Proximal variable pitch braid reinforcement provides support and torque control, Hand shapeable distal tip allows for quick, easy tip shaping saving time and helping navigate challenging anatomy, The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. Microcatheters. Indications may vary by region. Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. Visit clinicaltrials.gov for more information. 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 BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. 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. Coil Assist Stents. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Created with Sketch. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. The balloon provides temporary vascular occlusion during these and other angiographic procedures. 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.