Penumbra’s newest generation of Indigo aspiration system receives FDA clearance for pulmonary embolism

Indigo aspiration system Lightning 12

Penumbra today announced US Food and Drug Administration (FDA) 510(k) clearance for expanded indication of the latest iteration of the Indigo aspiration system, Lightning 12.

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 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 Adam Elsesser, president and chief executive officer, Penumbra. “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.”

The Indigo System Lightning 12 is the company’s newest generation aspiration system for peripheral thrombectomy. Lightning 12 combines the Indigo System CAT12 aspiration catheter with lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system’s unique clot detection mechanism.

CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to provide deliverability and torqueability within the body. According to a press release, this combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbra’s most advanced clot removal technology for the treatment of PE.


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