Penumbra announces FDA clearance of Indigo Aspiration System for treatment of pulmonary embolism

January 10, 2020
ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the Indigo® Aspiration System. As part of the Indigo Aspiration System, the Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and now, for the treatment of pulmonary embolism.

Penumbra introduced the Indigo System, a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature, in 2014. The Indigo System utilizes the Penumbra ENGINE™ aspiration source to deliver nearly pure, continuous vacuum suction to the Indigo System Aspiration Catheters to address emboli and thrombus in vessels of various sizes.

About Pulmonary Embolism
Pulmonary embolism (PE) is a condition that occurs when blood clots, typically traveling from the veins in the legs, get caught in the arteries of the lungs. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. According to the American Heart Association, PE affects roughly 300,000 Americans per year.1

About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets innovative products and has a broad portfolio that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra P logo, Indigo, and Penumbra ENGINE are trademarks of Penumbra, Inc.