Aliso Viejo, CA – April 20, 2022 – 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 […]
Category: Industry News
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Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval
MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB 17 System, designed with the latest microbraid technology, features […]
MIVI Neuroscience Receives IDE to Study Q Aspiration Catheter
MIVI Neuroscience announced that the FDA has approved an investigational device exemption to initiate a human clinical study of the MIVI Q aspiration catheter in the United States. EVaQ is a prospective, multicenter, single-arm study of the Q revascularization system for neurointervention in acute ischemic stroke. According to the company, the study will assess the […]
MicroVention Announces FDA Premarket Approval of a New Flow Diverter for the Treatment of Brain Aneurysms
MicroVention, Inc., a U.S. based subsidiary of Terumo and a global neurovascular company announced the FDA Premarket Approval (PMA) for the FRED® (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms. The FRED® device is the first flow diverter in the U.S. to use a self-expanding braided nitinol mesh to help re-direct blood […]
Balt USA, LLC Announces CE Mark Obtained for Titan™ Aspiration Catheter
The Titan catheter line consists of a highly navigable, large bore aspiration catheter and a smaller bore catheter for navigation and support. Balt USA, LLC announced today it has obtained CE mark for the Titan aspiration catheter. The Titan catheter line consists of a highly navigable, large bore (.070″) aspiration catheter and a smaller bore […]