Results from the EXTRACT-PE trial, which found that Penumbra’s Indigo aspiration system met its predefined safety and efficacy endpoints for the treatment of pulmonary embolism (PE), have been published in JACC: Cardiovascular Interventions.
Penumbra’s Indigo system is designed to remove clot from arteries and veins in the peripheral vasculature. It was introduced in 2014, and Penumbra announced it received clearance for the PE indication in January 2020.
The EXTRACT-PE (Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism) study was a prospective, single-arm, multicentre study that sought to evaluate the safety of the Indigo system in submassive acute PE.
Authors Akhilesh K Sista (NYU Grossman School of Medicine, New York, USA) and colleague report a significant reduction in RV/LV ratio, a low major adverse event rate in submassive PE patients, and avoidance of intraprocedural thrombolytics in 98.3% of patients.