Penumbra Earns Expanded FDA Clearance for Aspiration System

Penumbra has received 510(k) clearance for expanded indication of its Indigo aspiration system, a continuous aspiration mechanical thrombectomy device.

The system is now indicated for treating pulmonary embolisms, which occur when blood clots get stuck in the arteries of the lungs and can be fatal if the clots are large or numerous enough.

The device’s aspiration engine provides continuous vacuum suction to the system’s catheters to remove obstructions in various sized vessels in the peripheral vasculature.