Penumbra (NYSE:PEN) announced today that the FDA has granted expanded clearance for its Indigo aspiration catheter system, Lightning 12.
Indigo Lightning is 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, according to the Alameda, Calif.-based company.
Lightning 12 combines the Indigo System CAT 12 aspiration catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system’s clot-detection mechanism. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body.
“Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention,” said company president & CEO Adam Elsesser in a news release. “COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.”
