MIVI seeks FDA approval for stroke catheter as trial fulfils primary endpoint

MIVI Neuroscience showcased encouraging results at the 2024 International Stroke Conference in Phoenix, Arizona, USA, in February. They have submitted data to the US Food and Drug Administration (FDA) seeking clearance for their Q Revascularization System, based on the successful completion of their EvaQ acute ischemic stroke study (NCT04437862). The study achieved its primary objective with a revascularization success rate of 93.9%, meeting mTICI 2b-3 criteria as confirmed by an independent imaging core lab.

The EvaQ Trial data has been submitted to the FDA for approval of the Q Revascularization System. The system, available internationally since 2018 with a CE mark, targets the removal of fresh, soft emboli and thrombi in peripheral and neurovascular systems, or serves as a diagnostic angiographic catheter. FDA granted an investigational device exemption (IDE) in 2020 to start the EvaQ trial.

In acute ischemic stroke, where a brain blood vessel is blocked, aspiration catheters play a vital role by suctioning out blood clots or blockages to restore blood flow and oxygen supply to the affected brain area.