MicroVention’s STRAIT Study of the Bobby Balloon Guide Catheter Begins Enrollment

April 20, 2022—MicroVention, 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. STRAIT is evaluating the safety and performance of the company’s 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. The device is designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the company’s Sofia Plus 6-F aspiration catheter.

The STRAIT study’s Principal Investigator is Professor Tobias Boeckh-Behrens, MD, of Department of Diagnostic and Interventional Neuro Radiology at Klinikum rechts der Isar der Technischen Universität München in Munich, Germany, where the first patient in the study was enrolled. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD.

Dr. Maegerlein commented in MicroVention’s 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. 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.”

According to the company, the indications for these devices—which may vary by region—include the following:

• 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. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Bobby device is also indicated for use as a conduit for retrieval devices.
• 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 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.
• 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 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.