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.
The FDA panel will convene on November 1 to consider CoAxia's PMA submission based on data from the company's SENTIS trial, which closed 2 years ago this month.
SENTIS was "the first randomized trial of an acute interventional treatment in ischemic stroke patients to signal safety and long term improvement in clinical outcomes," the company said at the time.
The NeuroFlo device didn't achieve statistically significant levels of efficacy, but hit primary endpoints for safety, according to a press release.
In 2005 CoAxia won humanitarian device exemption for the NeuroFlo system in patients who had failed "maximal medical management," allowing physicians to use the device to stop or control blood flow in the peripheral blood vessels.
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