MIVI Neuroscience has submitted data to the US Food and Drug Administration (FDA) for clearance of its Q Revascularization System as the company’s EvaQ acute ischemic stroke study (NCT04437862) met its primary endpoint.
The trial successfully met its primary endpoint, demonstrating successful revascularisation in 93.9% of cases, meeting mTICI 2b-3 criteria as confirmed by an independent imaging core lab.
The EvaQ Trial data has been submitted to the FDA to gain clearance for the Q Revascularisation System. The system has been CE-marked since 2018 and available internationally for five years, specifically for removing fresh, soft emboli and thrombi in the peripherals and neurovascular systems, or as a diagnostic angiographic catheter. The FDA approved an investigational device exemption (IDE) back in 2020 to initiate the EvaQ trial.
An acute ischemic stroke occurs when a blood vessel in the brain becomes blocked, reducing blood flow and oxygen in the brain tissue. Aspiration catheters create suction to remove these blood clots or blockages from the blood vessels, restoring blood flow to the affected area of the brain.
According to a report on GlobalData’s Pharma Intelligence Center, the ischemic stroke market is forecast to be worth $10.6bn in the eight major markets (US, UK, France, Spain, Germany, Italy, Japan, and China) in 2027.
In the announcement accompanying the results, MIVI CEO Bob Colloton said: “We are encouraged by the results and the prospect of commercialisation of the Q Revascularisation System in the US, following FDA clearance.
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“This is a validating milestone and demonstrates our commitment to advancing technology that could improve the outcomes for acute ischemic stroke patients, worldwide.”
In January 2023, device company Infinity Neuro received CE Mark approval for its Inspira aspiration catheters to treat stroke. The Inspira aspiration catheters are designed to evaluate target vessels, restore cerebral blood flow quickly, and retrieve clots causing large vessel occlusion (LVO) and acute ischemic stroke in patients.