The FDA's Neurological Devices Panel will next month review CoAxia's NeuroFlo catheter for treatment of cerebral ischemia.
Privately held CoAxia Inc. landed a date with the FDA's Neurological Devices Panel to submit its NeuroFlo catheter for de novo approval.
The Minneapolis-based company's NeuroFlo device, which already has CE Marking for the European Union, aims to divert blood flow in the brain for patients suffering cerebral ischemia as a result of stroke, vasospasm, or other conditions.
The device boasts 35-50% improvement in cerebral perfusion and can be placed in 10-15 minutes via the abdominal aorta, according to the company's website.
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