FDA greenlights cerebral protection device for carotid stenting

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Interventional product developer Invatec has received 510(k) clearance from the FDA to market its Mo.Ma Ultra proximal cerebral protection device for use during carotid artery stenting.

The device captures debris released during the stenting procedure to prevent it from traveling to the brain, where it has the potential to cause a stroke, according to the Bethlehem, Pa.-based company. Guidewires, stents and occuding balloons can be used in this environment to treat the target lesion through the Mo.Ma Ultra device to the internal carotid artery, like a guiding catheter or sheath. The suspended blood is then aspirated along with embolic debris to complete the procedure.