FDA clearance granted to Penumbra for Indigo Aspiration System

indigo aspiration system by penumbra
Indigo Aspiration System

Penumbra has announced US Food and Drug Administration (FDA) 510(k) clearance for expanded indication of the Indigo Aspiration System. As part of the system, Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and now for the treatment of pulmonary embolism (PE).

Penumbra introduced the Indigo System, a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature, in 2014.

According to a press release, the Indigo System utilises the Penumbra ENGINE aspiration source to deliver nearly pure, continuous vacuum suction to the Indigo System Aspiration Catheters to address emboli and thrombus in vessels of various sizes.

Results of the EXTRACT-PE trial, a multicentre investigation conducted under an investigational device exemption (IDE), found that aspiration thrombectomy for acute PE with the Indigo Aspiration System meets primary efficacy and safety endpoints.

As well as achieving a reduction in RV:LV at 48 hours, the rate of major adverse events within 48 hours also compared favourably with the SEATTLE II and FLARE trials.

Commenting on these results, national principal investigator of EXTRACT-PE Akhilesh Sista (NYU Langone Health, New York, USA) said: “The positive results of the EXTRACT-PE trial, the first prospective safety and efficacy study of the Indigo Aspiration System, are a step forward in building needed clinical evidence around catheter-based embolectomy in patients with acute PE.”


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