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November 20, 2020

Penumbra’s Indigo Aspiration System Lightning 12 and Separator 12 Cleared for PE

November 20, 2020—Penumbra, Inc. announced FDA 510(k) clearance for an expanded indication for Lightning 12, the latest iteration of the company’s Indigo aspiration system. As part of the Indigo aspiration system, Lightning 12 (Indigo system CAT 12 aspiration catheter with Lightning intelligent aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, as well as for the treatment of pulmonary embolism (PE).

Penumbra launched the Lightning 12 in July 2020 and is available immediately for the interventional treatment for PE.

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