Penumbra (NYSE:PEN) announced additional results from its STORM-PE trial of computer-assisted vacuum thrombectomy (CAVT).
The data release follows STORM-PE findings shared last week supporting the use of the company’s Lightning Flash system at TCT 2025. Investigators shared additional results at this week’s Vascular Interventional Advances (VIVA) 2025 Conference in Las Vegas.
Lightning Flash is a mechanical thrombectomy system that addresses venous and pulmonary thrombus. It features Penumbra’s Lightning Intelligent Aspiration technology and the latest dual clot detection algorithms. Those algorithms utilize both pressure- and flow-based processes to detect blood clot and blood flow.
Penumbra’s latest findings include significantly greater improvements in thrombus burden reduction, heart rate, oxygen requirement, and functional outcomes using CAVT with anticoagulation. It compared this to anticoagulation alone in patients with acute intermediate-high risk pulmonary embolism (PE).
Dr. Rachel Rosovsky, a hematologist at Massachusetts General Hospital and associate professor at Harvard Medical School, served as co-principal investigator. She said the study highlighted the critical importance of early intervention while backing CAVT therapy.
“The latest STORM-PE findings demonstrate substantial improvements in both clinical and functional outcomes, with a significantly higher proportion of patients treated with CAVT plus anticoagulation returning to normalization within 48 hours compared to anticoagulation alone—a remarkable result,” said Rosovsky.
More from the Penumbra STORM-PE study
Penumbra reported that patients receiving CAVT plus anticoagulation experienced significantly lowered thrombus burden at 48 hours. They presented a 2.7 times larger reduction in refined modified Miller score (42.1% vs. 15.6%).
Investigators reported early physiological recovery with significantly lower heart rate, less tachycardia, reduced supplemental oxygen requirements and a lower risk of clinical deterioration. They saw a 2.2 times greater likelihood of progressing toward recovery of functional status.
Penumbra also reported longer distance walked during a 90-day six-minute walking test, plus near normalization of walking distance by 90 days. Safety rates through 90 days proved comparable, the company said. It saw no device-related mortality, no additional PE-related mortality greater than seven days and no difference in symptomatic PE recurrence. This confirmed the safety profile of CAVT.
“STORM-PE confirms that mechanical thrombectomy with CAVT has a significant impact on clinical and functional outcomes,” said Dr. James F. Benenati, chief medical officer at Penumbra. “The STORM-PE results demonstrate that CAVT can rapidly and safely improve patient outcomes and should be considered as a therapeutic option for patients with acute intermediate-high risk PE.”
