Neuroendovascular medical device company MicroVention has recruited the first patient in the multi-centre, prospective EU observational study, dubbed STRAIT, with the new BOBBY balloon guide catheter.
The study intends to analyse the safety and performance of the BOBBY balloon guide catheter for endovascular treatment of acute ischemic stroke.
The BOBBY balloon guide catheter is designed to aid in the insertion and guiding of an intravascular catheter into a specific blood artery in the peripheral and neurovascular systems.
During these and other angiographic procedures, the balloon offers temporary vascular blockage. The balloon guide catheter is also indicated for use as a retrieval device conduit.
Designed to streamline balloon preparation, the BOBBY balloon guide catheter is already approved in Europe and North America.
It is also compatible with the SOFIA Plus 6Fr aspiration catheter and offers improved navigability.
STRAIT study recruited the first patient at the site of the Principal Investigator PD. Dr. med. Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology.
Dr Christian Maegerlein, who treated the patient with the BOBBY device, said: “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.”
MicroVention president and chief executive officer Carsten Schroeder said: “The STRAIT trial is intended to provide clinical evidence that MicroVention’s new balloon guide catheter can effectively contribute to improved clinical outcomes.”
In January 2020, MicroVention announced the FDA premarket approval for the FRED (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms.
MicroVention, a wholly-owned subsidiary of Terumo, develops and sells medical equipment for the treatment of cerebrovascular diseases.
