Penumbra’s Indigo Aspiration System Shows Clot Burden Reduction in EXTRACT-PE Subgroup Analysis

June 8, 2022—Penumbra, Inc. announced new data on the company’s Indigo aspiration system for the treatment of submassive pulmonary embolism (PE) regardless of clot location.

The findings from the study, “Clot Burden Reduction After Aspiration Thrombectomy in Main Versus Branch Pulmonary Artery Emboli: A Subgroup Analysis of the EXTRACT-PE Trial,” by Salah Qannadli, MD, et al were presented at LINC 2022, the Leipzig Interventional Course held June 6-9 in Leipzig, Germany.

According to the company, the EXTRACT-PE subgroup analysis study demonstrated the following:

• A right ventricular/left ventricular (RV/LV) ratio reduction of 28.2% and 26.8% in the main pulmonary artery (PA) and branch vessels, respectively
• A systolic PA pressure reduction of 8.1% and 8.4% in the main vessel and branch vessels, respectively

As summarized in the investigators’ abstract from LINC, the EXTRACT-PE trial evaluated the safety and performance of the Indigo 8-F system for the treatment of PE without thrombolytics. This subgroup analysis evaluated performance outcomes of patients with main PA emboli versus discrete unilateral or bilateral PA emboli without main PA involvement.

Of 119 patients, 44 (37%) had emboli that involved the main PA, and 75 (63%) had branch emboli. No significant difference was observed between these groups for procedural device time, change in RV/LV ratio, or systolic PA pressure from before to after treatment. Mean absolute reduction in clot burden was significant in both groups: main PA, 3.6 (P = .029), and branch vessels, 5.8 (P < .001).

“The Indigo aspiration system was effective at improving clinical outcomes for submassive PE patients regardless of emboli location. Clot burden was significantly reduced in both groups,” concluded the investigators in the LINC abstract.

James F. Benenati, MD, Penumbra Chief Medical Officer, commented in the announcement, “The data from this study suggest that the Indigo catheter system is an excellent device for the treatment of PE. The Indigo system can be used equally effectively for proximal and distal aspiration thrombectomy in the PAs.”

In January 2021, the company announced that findings from the multicenter prospective EXTRACT-PE evaluating the safety and efficacy of the Indigo aspiration system in submassive acute PE were published by Akhilesh K. Sista, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. The EXTRACT-PE study demonstrated that the Indigo device was associated with a significant reduction in RV/LV ratio and a low major adverse event rate in submassive PE patients; additionally, intraprocedural thrombolytic drugs were avoided in 98.3% of patients.