MIVI Neuroscience has announced today that the US Food and Drug Administration (FDA) has approved an investigational device exemption for the initiation of a human clinical study of the MIVI Q aspiration catheter in the USA. EVaQ is a prospective, multicentre, single-arm study of the Q revascularisation system for neurointervention in acute ischaemic stroke.
According to the company, the study will assess the Q catheter’s ability to remove thrombus that causes large vessel occlusions in the arteries of the brain. Patient enrolment is planned at up to 12 clinical centres in the USA and additional sites in the European Union.
Principal investigators for the EvaQ study are Lucas Elijovich, with the Semmes Murphy Clinic in Memphis, USA; Brian Jankowitz, with Cooper University Health Care in Camden, USA; and professor Christophe Cognard, with Purpan University Hospital in Toulouse, France.