Penumbra’s Newest Generation of Indigo Aspiration System Receives FDA Clearance for Pulmonary Embolism

Penumbra announced U.S. Food and Drug Administration 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.

Pulmonary embolism, or PE, is a deadly condition causing blood clots within a patient’s lungs that has grown in prevalence during the COVID-19 pandemic. The Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays.

“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 CAT™12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing 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 advanced deliverability and torqueability within the body. This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbra’s most advanced clot removal technology for the treatment of pulmonary embolism.

The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE.

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