January 9, 2020
Penumbra’s Indigo Aspiration System Receives Expanded Indication for the Treatment of Pulmonary Embolism
January 9, 2020—Penumbra, Inc. announced its Indigo aspiration system has received United States FDA 510(k) clearance for an expanded indication for the treatment of pulmonary embolism.
The Indigo aspiration system, which includes the Indigo aspiration catheters and separators, is also indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
According to Penumbra, the Indigo aspiration system is a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature. The system uses the company’s Engine aspiration source to deliver nearly pure, continuous vacuum suction for the Indigo aspiration catheters to treat emboli and thrombus of various sizes.
The Indigo aspiration system is approved for use in the United States and European Union.