Penumbra Presents STORM-PE 90-day Results at SIR

April 13, 2026 — Penumbra, Inc.  announced 90-day results of the landmark STORM-PE randomized controlled trial (RCT), which found that patients with acute intermediate-high risk pulmonary embolism (PE) who were treated with computer assisted vacuum thrombectomy (CAVT) plus anticoagulation achieved greater functional improvement, including walking significantly further and a higher proportion of patients achieving NYHA Class I (no physical limitations), compared to anticoagulation alone. The first-of-its kind data were presented at the Society of Interventional Radiology (SIR) Annual Scientific Meeting in Toronto.

"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," said Robert Lookstein, MD, MSc, co‑global principal investigator of the STORM‑PE randomized controlled trial and professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai. "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."

At 90 days, patients treated with CAVT plus anticoagulation:

• Walked significantly longer distances during the six-minute walk test (479m vs 368m; P=0.003).
• Near normalized, walking 94% of their predicted walk distance vs 75.2% in the anticoagulation only arm (P=0.022).
• Experienced no physical limitation based on New York Heart Association (NYHA) Functional Class Scale compared to the anticoagulation only arm (97% vs 76%, P = 0.022).
• Returned to pre-PE functional status distribution while the anticoagulation only arm did not.
• Improved quality of life and reduced shortness of breath, which were comparable in both arms.

Additionally, safety rates through 90 days were comparable in both arms, with no device-related mortality, no additional PE-related mortality past 7 days, and no difference in symptomatic PE-recurrence, confirming the safety profile of CAVT¹.

"STORM-PE continues to highlight emerging benefits of treatment beyond anticoagulation alone for patients with intermediate‑high risk PE," said Rachel Rosovsky, MD, MPH, 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. "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."

Additionally, new interim analysis from STRIKE-PE, highlighting long-term quality-of-life data and functional outcomes in male and female PE patients who received CAVT, will be presented at SIR. STRIKE-PE is a prospective, international, multicenter study evaluating real-world safety, performance and long-term quality-of-life outcomes of CAVT in up to 1,500 patients.

"Historically, there has been limited randomized evidence describing how different treatment strategies for PE influence longer‑term recovery," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "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."

In the U.S., an estimated 900,000 cases of venous thromboembolism, which includes PE, occur annually.² PE can be life-threatening, representing the third leading cause of cardiovascular death after heart attack and stroke.³ Penumbra's Lightning Flash portfolio is the most advanced mechanical thrombectomy system on the market, and the only CAVT system designed to address venous and pulmonary thrombus. It features Penumbra's Lightning CAVT technology with the latest dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow. The portfolio is designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body's complex anatomy and deliver high power aspiration for clot removal.

1. STORM-PE was not powered to detect differences in safety

2. "Learn about Pulmonary Embolism," American Lung Association. Accessed Oct. 7, 2025. www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism

3. "Pulmonary Embolism: A Clinical Approach," American College of Cardiology. Accessed on Oct. 9, 2025. www.acc.org/Latest-in-Cardiology/Articles/2025/02/01/42/Cover-Story-Pulmonary-Embolism#:~:text=Pulmonary%20embolism%20(PE)%20continues%20to,venous%20thromboembolism%20in%20the%20country.