Penumbra’s CAVT Evaluated in 90-Day STORM-PE Data

April 13, 2026—Penumbra, Inc. announced 90-day results of the STORM-PE randomized controlled trial (RCT) that is evaluating computer-assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash device plus anticoagulation versus anticoagulation alone for the treatment of patients with acute intermediate-high risk pulmonary embolism (PE).

The company reported that patients treated with the Penumbra CAVT system plus anticoagulation achieved far greater functional improvement compared to anticoagulation alone. Additionally, a higher proportion of patients receiving CAVT achieved New York Heart Association (NYHA) class I (no physical limitations).

The 90-day data were presented at SIR 2026, the Society of Interventional Radiology’s annual scientific meeting in Toronto, Canada.

According to Penumbra, the pivotal, prospective, multicenter STORM-PE RCT enrolled 100 patients across 22 international sites. Robert Lookstein, MD, and Rachel Rosovsky, MD, served as Coglobal Principal Investigators of STORM PE, which was conducted in partnership with The PERT Consortium.

The STORM-PE trial’s primary efficacy endpoint was reduction in right ventricle/left ventricle ratio at 48 hours, assessed by a blinded independent core laboratory. All safety events were independently adjudicated by an external clinical events committee. Dr. Lookstein presented the 48-hour data at the TCT 2025 scientific symposium in October.

As outlined in Penumbra’s press release, patients treated with CAVT plus anticoagulation demonstrated the following at 90 days versus those treated only with anticoagulation:

• Walked significantly longer distances during the 6-minute walk test (479 m vs 368 m; P = .003).
• Near normalized, walked 94% of their predicted walk distance versus 75.2% (P = .022).
• Experienced no physical limitation based on NYHA functional class scale (97% vs 76%; P = .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.

Additionaly, Penumbra advised that safety rates through 90 days were comparable, 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.

“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,” commented Dr. Lookstein in the Penumbra press release. “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.”

Dr. Rosovsky added, “STORM PE continues to highlight emerging benefits of treatment beyond anticoagulation alone for patients with intermediate-high risk PE. 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 such has the potential to greatly improve patient outcomes and recovery.”