JACC Study: PEN Indigo Aspiration System Meets Safety/Efficacy Endpoints

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A study published online first in the JACC: Cardiovascular Interventions found that Penumbra, Inc.’s Indigo Aspiration System met its predefined safety and efficacy endpoints for the treatment of pulmonary embolism (PE) in the EXTRACT-PE study. Specific results include a significant mean reduction in right ventricular (RV)/left ventricular (LV) ratio of 0.43, corresponding to a 27.3% reduction, at 48 hours after intervention; major adverse event composite rate of 1.7% within 48 hours; and intraprocedural thrombolytics were avoided in 98.3% of patients (all but two). EXTRACT-PE was a prospective, single-arm, multicenter study that enrolled 119 participants across 22 U.S. study centers.