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
The US FDA’s Center for Devices and Radiological Health (Credit: The U.S. Food and Drug Administration)
Penumbra, 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.
Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use.
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.
Penumbra, 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.
Source: Company Press Release