Late Breaking

Safety and Efficacy of the Indigo Aspiration System in Patients with Acute Pulmonary Embolism: Results from a Prospective, Single-Arm, Multicenter IDE Study (EXTRACT-PE)

Presented During:

Sat, 6/13/2020: 12:41 PM  - 12:50 PM 
Room: Webinar  

Final ID:



A Sista1, J Horowitz2, V Tapson3, J Benenati4


1NYU School of Medicine, New York, NY, 2NYU Langone Health, Brooklyn, NY, 3Cedars Sinai, Los Angeles, CA, 4Maimi Cardiac and Vascular Institute, Miami, FL

First Author:

Akhilesh K. Sista, MD, FSIR  
NYU School of Medicine
New York, NY


James Horowitz, MD  
NYU Langone Health
Brooklyn, NY
Victor Tapson, MD  
Cedars Sinai
Los Angeles, CA
James F. Benenati, MD, FSIR  
Maimi Cardiac and Vascular Institute
Miami, FL

Presenting Author:

Akhilesh K. Sista, MD, FSIR  
NYU School of Medicine
New York, NY


To evaluate the safety and efficacy of aspiration thrombectomy with the Indigo® Aspiration System (Penumbra, Inc., Alameda CA) in patients with acute pulmonary embolism (PE).


EXTRACT-PE was a prospective, single-arm, multicenter IDE trial that enrolled patients with symptomatic acute PE ≤14 days duration diagnosed by computed tomography angiography (CTA). Patients were included if they had a systolic BP ≥90 mmHg, a right ventricular (RV)/left ventricular (LV) ratio >0.9, and if they were ≥18 years of age. The primary efficacy endpoint was reduction in RV/LV ratio from baseline to 48 hours, assessed by CTA. The primary safety endpoint was the rate of major adverse events, a composite of device-related death, major bleeding, and device-related SAEs (clinical deterioration, pulmonary vascular injury, and cardiac injury) within 48 hours.


119 patients (mean age of 59.8±15.0 years) were enrolled at 22 US sites from Nov 2017 to Mar 2019. Median time from device insertion to removal was 37.0 min (IQR 23.5-60.0). Two patients (1.7%) received intraprocedural thrombolytics. Median hospital ICU stay was 1.0 day (IQR 1.0-2.0). Mean reduction in systolic pulmonary artery pressures from pre- to post-Indigo and pre- to post-procedure were 4.3 mm Hg (95% CI 2.6-5.9; p<0.0001) and 4.7 mm Hg (95% CI 3.0-6.4; p<0.0001), respectively.
Mean RV/LV ratio reduction at 48 hours was 0.43 (95% CI 0.38-0.47; p<0.0001) corresponding to a 27.3% reduction. The rate of major adverse events was 1.7% (2 patients experienced 3 events). Secondary safety endpoints included rates of cardiac injury (0%), pulmonary vascular injury (1.7%), clinical deterioration (1.7%), major bleeding (1.7%), and device-related death (0.8%) within 48 hours. Rates of any-cause mortality, device-related SAEs, and symptomatic PE recurrence within 30 days were 2.5%, 1.7%, and 0%, respectively.


Aspiration thrombectomy with the Indigo Aspiration System rapidly reduced intra-procedure pulmonary artery pressure, was associated with a significant reduction in the RV/LV ratio at 48 hours, and met its pre-specified safety endpoint. These results were achieved without the use of intraprocedural thrombolytics in 98.3% of patients.

Abstract Categories:

Venous Interventions: Thrombolysis/Thrombectomy


Aspiration Thrombectomy
Pulmonary embolism