MIVI Neuroscience won FDA approval to start a human clinical study of its MIVI Q aspiration catheter in the U.S.
The EVaQ Study V catheter’s ability to remove thrombus and blockages that can cause large vessel occlusions in arteries of the brain.
This study is a single-arm study with planned patient enrollment in up to 12 clinical centers in the U.S. with additional sites in the European Union.
“MIVI looks forward to working with FDA to incorporate the recommended protocol modifications in order to initiate and complete the EVaQ Study in the most rapid manner, and ultimately support a marketing clearance submission,” CEO Bob Colloton said in a news release. “We are very excited about the future of the Q Catheter in the United States, building off the success of our devices in Europe.”