Penumbra released the 90‑day results of its STORM‑PE randomized controlled trial, enrolling 100 patients with intermediate‑high risk pulmonary embolism. The study found that patients treated with Penumbra’s computer‑assisted vacuum thrombectomy (CAVT) plus anticoagulation achieved significantly better functional outcomes than anticoagulation alone, with a higher proportion reaching New York Heart Association Class I and an improved 6‑minute walk distance.
Safety outcomes were comparable between the two arms. No device‑related mortality occurred, no additional pulmonary embolism‑related deaths were observed beyond seven days, and there was no increase in symptomatic PE recurrence. These data provide the first Level 1 evidence that mechanical thrombectomy can outperform anticoagulation alone in this patient population.
The trial’s results reinforce the clinical benefit of CAVT in a group that traditionally relies on anticoagulation alone and support broader adoption of Penumbra’s Lightning Flash system in pulmonary embolism protocols. The findings may accelerate integration of CAVT into standard care pathways, potentially driving future revenue growth for the company. The Lightning Flash 3.0 platform, launched shortly before the announcement, and interim data from the prospective international STRIKE‑PE study further underscore the platform’s real‑world safety and efficacy.
"This pivotal trial continues to build important clinical evidence supporting the role of endovascular therapy beyond anticoagulation alone and helps inform how treatment strategies including CAVT for PE may continue to evolve in future clinical guidelines," said Robert Lookstein, MD, MSc, co‑global principal investigator of the STORM‑PE trial.
The 90‑day data were presented at the Society of Interventional Radiology Annual Scientific Meeting, held April 11‑15 2026, and a prospective international STRIKE‑PE study will provide additional real‑world safety and efficacy data.
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