STORM-PE evaluates patients with acute intermediate-high risk pulmonary embolism (PE) treated with computer-assisted vacuum thrombectomy (CAVT). It utilizes the Alameda, California-based company’s Lightning Flash thrombectomy system.
According to a news release, the study showed that CAVT plus anticoagulation achieved greater functional improvement compared to anticoagulation alone. Improvements included walking significantly further and achieving NYHA Class I (no physical limitations).
Penumbra presented findings at the Society of Interventional Radiology (SIR) Annual Scientific Meeting in Toronto. They add to outcomes shared at the Vascular Interventional Advances (VIVA) 2025 Conference in November and STORM-PE findings shared in October supporting the use of the company’s Lightning Flash system at TCT 2025.
(The company is also subject to a planned $14.5 billion acquisition by Boston Scientific. Read more about that here.)
A look at Lightning Flash and the data shared by Penumbra
Penumbra reported that, at 90 days, patients receiving CAVT plus anticoagulation walked significantly longer distances (479 meters vs. 368 meters) in a six-minute walk test. Walkers experienced no physical limitation compared to the anticoagulation-only arm.
Additionally, CAVT recipients returned to pre-PE functional status distribution, while the anticoagulation-only arm failed to. The therapy improved quality of life and reduced shortness of breath, a metric that proved comparable in both arms.
Safety rates through 90 days were comparable across both arms. Investigators saw no device-related mortality, no additional PE-related mortality past seven days and no difference in symptomatic PE recurrence. Penumbra says this confirmed the safety profile of CAVT.
The company also shared a new interim analysis from STRIKE-PE, highlighting long-term quality of life data and functional outcomes. The real-world study evaluates CAVT in up to 1,500 patients.
Penumbra says its Lightning Flash portfolio is the most advanced mechanical thrombectomy system on the market. It describes it as the only CAVT system designed to address venous and pulmonary thrombus. The platform features Penumbra’s Lightning CAVT technology with the latest dual clot detection algorithms.
Lightning Flash uses both pressure- and flow-based processes to detect blood clot and blood flow. The company designed the portfolio to help remove blood clots with speed, safety and simplicity. It aims to allow physicians to better navigate the body’s complex anatomy and deliver high power aspiration for clot removal.
Commentary from investigators and Penumbra officials
Dr. Robert Lookstein, co-global principal investigator of the STORM-PE RCT and professor of radiology and surgery at Icahn School of Medicine at Mount Sinai, said:
“Together with the initial STORM‑PE results, which demonstrated faster reperfusion and improved right ventricular recovery, this 90 day data highlights significant patient‑centered benefits of CAVT in intermediate‑high risk PE. 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.”
Dr. Rachel Rosovsky, co‑global principal investigator of the STORM‑PE randomized controlled trial, hematologist at Massachusetts General Hospital, and associate professor of medicine at Harvard Medical School, said:
“STORM-PE continues to highlight emerging benefits of treatment beyond anticoagulation alone for patients with intermediate‑high risk PE. These functional endpoints are important because they reflect outcomes that matter to patients and directly affect their daily lives. Collectively, the STORM‑PE data suggest that PE care is evolving, and that the thoughtful adoption of endovascular treatment options has the potential to greatly improve patient outcomes and recovery.”
Dr. James F. Benenati, Penumbra chief medical officer, said:
“Historically, there has been limited randomized evidence describing how different treatment strategies for PE influence longer‑term recovery. In STORM‑PE, those treated with CAVT achieved significantly greater gains in objective functional measures, including 6‑minute walk distance, compared to anticoagulation alone. Data from STRIKE-PE support a similar recovery trajectory in a broader patient population. Together, these findings provide robust evidence supporting a greater role for CAVT in the treatment of acute intermediate‑high risk PE and reinforce its impact on physiological and functional outcomes.”
