Microvention, a wholly owned subsidiary of Terumo Corporation, has announced the successful completion of its first patient enrolment in a multicentre, prospective, observational study called STRAIT.
The European Union (EU) study will evaluate the safety and performance of the company’s new BOBBY balloon guide catheter in the endovascular treatment of acute ischaemic stroke.
BOBBY is currently approved in Europe and North America, according to a Microvention press release, and has been designed to streamline balloon preparation while improving navigability and ensuring compatibility with the SOFIA plus 6Fr aspiration catheter (Microvention/Terumo).
The first STRAIT study patient was enrolled at the site of its principal investigator, Tobias Boeckh-Behrens (Technischen Universität München [TUM], Munich, Germany).
Christian Maegerlein (TUM, Munich, Germany), 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 [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 6Fr aspiration catheter, Headway microcatheter, Traxcess EX guidewire [both Microvention/Terumo] and the 6×40 stent retriever revascularisation device.”
Carsten Schroeder, president and CEO of Microvention, noted: “The STRAIT trial is intended to provide clinical evidence that Microvention’s new balloon guide catheter can effectively contribute to improved clinical outcomes.”