Penumbra CAVT plus anticoagulation yields 479m vs 368m walk, 97% NYHA I
Penumbra’s STORM-PE trial showed 90-day outcomes for intermediate-high risk PE patients treated with CAVT plus anticoagulation included a 6-minute walk distance of 479m versus 368m (P=0.003) and 97% achieving NYHA Class I versus 76%. Safety profiles were comparable, with no device-related mortality through 90 days.
1. STORM-PE 90-Day Efficacy Outcomes
The STORM-PE randomized trial enrolled 100 intermediate-high risk PE patients across 22 sites to compare computer assisted vacuum thrombectomy (CAVT™) plus anticoagulation versus anticoagulation alone. At 90 days, the CAVT arm walked 479m on the six-minute test versus 368m in the control arm (P=0.003) and reached 94% of predicted walk distance versus 75.2% (P=0.022), with 97% achieving NYHA Class I versus 76% (P=0.022).
2. Safety and Tolerability
Safety endpoints through 90 days showed no device-related mortality, no additional PE-related deaths beyond seven days, and no difference in symptomatic PE recurrence between arms. These comparable safety profiles reinforce the procedural reliability of CAVT when added to standard anticoagulation in acute PE care.
3. STRIKE-PE Interim Analysis
Interim STRIKE-PE data set to be presented will evaluate long-term quality-of-life and functional outcomes in up to 1,500 real-world PE patients treated with CAVT. This prospective international study aims to validate STORM-PE findings in broader patient demographics and support sustained recovery trajectories.
4. Commercial and Guideline Implications
Positive STORM-PE results may accelerate incorporation of CAVT into clinical guidelines for intermediate-high risk PE and drive adoption of Penumbra’s Lightning Flash™ portfolio. Enhanced functional recovery metrics could support reimbursement discussions and expand market penetration for endovascular PE therapies.