Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510(k) approval for the new generation of its Indigo Aspiration System, Lightning 12.

The system is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems for the treatment of pulmonary embolism.

Combining the Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration, Lightning 12 is the company’s latest aspiration system for peripheral thrombectomy.

Lightning 12 and Separator 12 are part of the company’s Indigo Aspiration System that is indicated for the treatment of pulmonary embolism.

Penumbra president and chief executive officer Adam Elsesser said: “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.

“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.”

Lightning 12 combines intelligent aspiration and large-lumen catheter engineering

Pulmonary embolism (PE) is a condition characterised by blood clots that usually travel from the veins in the legs, and caught in the arteries of the lungs.

Blood clots in the lungs have the potential to block the lungs from absorbing oxygen, causing strain on the heart and other organs.

The Indigo Aspiration System is intended to remove the difficult-to-access, life-threatening clots, thereby reducing the need for thrombolytics and the associated ICU stays, said the company.

Also, the system enables physicians to focus on optimising thrombus removal using its unique clot detection mechanism.

CAT12 is a large-lumen aspiration catheter that includes novel laser-cut hypotube-based catheter engineering for advanced deliverability and torqueability within the body.

With the combination of intelligent aspiration and large-lumen catheter engineering, Lightning 12 is said to provide an advanced clot removal technology for the treatment of pulmonary embolism.