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. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA™ Plus 6Fr Aspiration Catheter.
The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. Dr. med. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universität München). Dr. med. 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. 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 6×40 stent retriever revascularization device.”
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 BOBBY™ Balloon Guide Catheter
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 balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
About the Headway™ Microcatheter
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.
About Traxcess™ EX Guidewire
The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. The device is not intended for use in coronary arteries.
About the SOFIA™ Aspiration Catheter
The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIA Catheter is not intended for use in coronary arteries. 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.
Indications may vary by region. Please consult the device Instruction For Use for more information.
About MicroVention, Inc.
Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Terumo’s acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership.
www.microvention.com
About Terumo Corporation
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. 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. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. 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 will further strive to be of value to patients, medical professionals, and society at large.
www.terumo.com
