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 Q catheter’s ability to remove thrombus that causes large vessel occlusions in the arteries of the brain.  Patient enrollment is planned at up to 12 clinical centers in the United States and additional sites in the European Union.

Principal investigators for the EVaQ study are Lucas Elijovich, MD, with the Semmes-Murphey Clinic in Memphis, Tennessee; Brian Jankowitz, MD, with Cooper University Health Care in Camden, New Jersey; and Professor Christophe Cognard, MD with Purpan University Hospital in Toulouse, France.