On Sunday, October 26, 2025, Penumbra, Inc. announced the results of the landmark STORM‑PE randomized controlled trial, the first level‑1 evidence that its Lightning Flash computer‑assisted vacuum thrombectomy (CAVT) combined with anticoagulation outperforms anticoagulation alone in patients with intermediate‑high risk pulmonary embolism. The 100‑patient, 22‑site study demonstrated a mean reduction in right‑to‑left ventricular (RV/LV) diameter ratio of 0.52 versus 0.24 in the CAVT arm, and 78.3% of patients achieved a positive treatment effect compared with 51.9% in the control group. Major adverse event rates were comparable, with 4.3% in the CAVT group versus 7.5% in the anticoagulation‑only group, underscoring the safety of the combined approach.
The trial’s outcomes were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference on October 26, 2025, and additional data will be shared at upcoming VEINS and VIVA conferences in early November. The rapid hemodynamic improvement observed—most patients achieving normalization of RV/LV ratio within 48 hours—could influence future treatment guidelines and accelerate adoption of Penumbra’s CAVT platform in the pulmonary embolism market. By providing robust clinical evidence, the study strengthens Penumbra’s position as the leading thrombectomy company and supports its broader strategy of expanding the use of CAVT across multiple disease states.
The STORM‑PE results reinforce Penumbra’s narrative of delivering clinically meaningful, technology‑driven solutions that improve patient outcomes while maintaining a favorable safety profile. The data support the company’s ongoing efforts to position CAVT as a first‑line therapy for intermediate‑high risk pulmonary embolism, potentially expanding its addressable market and driving future revenue growth. As guideline panels consider these findings, Penumbra stands to benefit from increased market penetration and a reinforced competitive moat in the thrombectomy and embolization space.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.