Terumo’s wholly-owned subsidiary, MicroVention, has announced the enrollment of the first participant in the STRAIT study of its new BOBBY Balloon Guide Catheter.
A multicenter prospective observational study, STRAIT, is being conducted in the European Union (EU).
It was designed to evaluate the safety and performance of the BOBBY Balloon Guide Catheter for the endovascular treatment of acute ischemic stroke.
The new Balloon Guide Catheter has been designed to allow insertion and guidance of the intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
During these and other angiographic procedures, the balloon provides temporary vascular occlusion.
MicroVention President and CEO Carsten Schroeder said, “The STRAIT trial aims to provide clinical evidence that MicroVention’s new balloon guide catheter can effectively help improve clinical outcomes.
The BOBBY device streamlines balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter.
It is currently approved in North America and Europe and is also indicated for use as a conduit for retrieval devices.
The SOFIA Aspiration Catheter is designed to remove/aspirate emboli and thrombi from certain blood vessels of the arterial system, including neuro and peripheral vessels.
It can be used to facilitate the introduction of diagnostic or therapeutic agents.
Last January, MicroVention’s WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA clearance.
Designed with the latest microbraid technology, the WEB 17 system is intended for the treatment of wide neck intracranial bifurcation aneurysms.