Penumbra Inc Announces 90-Day Results of Storm-Pe Randomized Controlled Trial

Published: 2026-04-13 14:20:44 ET PEN

Published on 04/13/2026 at 02:20 pm EDT

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 this week's Society of Interventional Radiology (SIR) Annual Scientific Meeting. 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 CAVT. 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 on April 15. 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.

In the U.S., an estimated 900,000 cases of venous thromboembolism, which includes PE, occur annually. PE can be life-threatening, representing the third leading cause of cardiovascular death after heart attack and stroke. 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.