Penumbra Presents Results for STORM-PE and STRIKE-PE, Adding to a Growing Body of Evidence Backing CAVT

Penumbra presented multiple data sets at the International Symposium on Endovascular Therapy in Miami last month, including landmark data from the STORM-PE randomized controlled trial, and the latest data from the STRIKE-PE trial. Penumbra also hosted a product symposium with distinguished presenters sharing cases and techniques enabled by Penumbra’s Computer Assisted Vacuum Thrombectomy (CAVT™) technology.

Landmark Findings from the STORM-PE Randomized Controlled Trial

The STORM-PE trial marks a major milestone in pulmonary embolism (PE) research — representing the first randomized controlled trial directly comparing mechanical thrombectomy with anticoagulation alone for the treatment of acute intermediate-high risk PE. Dr. Robert Lookstein, MD, MSc; co-global principal investigator of the STORM-PE RCT and professor of radiology and surgery at Icahn School of Medicine at Mount Sinai, delivered encore presentations of the primary results, physiological parameters, and early functional outcomes.

Investigators across 22 international sites enrolled 100 patients, rigorously comparing physiologic, imaging based, and functional outcomes between endovascular treatment using the Lightning Flash^® CAVT system with anticoagulation vs. standard anticoagulation alone.

“These impressive functional outcomes combined with superior reduction in right heart strain add to the growing body of evidence demonstrating the significant impact CAVT can have on acute PE patients,” said Dr. Lookstein. “This is a foundational trial that will significantly advance PE care, allowing these advanced therapies to be offered to more patients, improving patient outcomes, and potentially leading to the inclusion in future treatment guidelines.”

Key Findings from the STORM Trial:^1,2

• Patients treated with CAVT demonstrated a greater reduction in right-to-left ventricular (RV/LV) diameter ratio within 48 hours (mean reduction 0.52 vs. 0.24; P < 0.001).
• Nearly 80% of patients had positive treatment effect (>0.2 reduction) with CAVT which was significantly greater than the patients who received anticoagulation alone (78.3% vs. 51.9%; P = 0.011), reflecting rapid hemodynamic recovery.
• The rate of major adverse events (MAE) within 7 days — including a composite of PE-related mortality, symptomatic recurrent PE, clinical deterioration requiring rescue therapy, and major bleeding — was comparable between groups (4.3% [2/47] with CAVT vs. 7.5% [4/53] with anticoagulation alone).
• CAVT patients demonstrated significantly lowered thrombus burden at 48 hours, with a 2.7 times larger reduction in refined modified Miller score (42.1% relative mean reduction with CAVT vs. 15.6% with anticoagulation alone; P < 0.001).
• CAVT patients experienced early physiological recovery with significantly lower mean heart rate (80.0 bpm with CAVT vs 86.4 bpm with anticoagulation alone; P = 0.022) and less tachycardia (heart rate > 100, 2.2% with CAVT vs 20% with anticoagulation alone; P = 0.008), reduced mean supplemental oxygen requirements (0.5 L/min with CAVT vs 1.4 L/min with anticoagulation alone; P = 0.027), and a lower NEWS2 risk of clinical deterioration (1.8 with CAVT vs. 2.7 with anticoagulation alone; P = 0.034) at 48 hours.
• CAVT patients had 2.2 times greater likelihood of progressing towards recovery of functional status, based on post-venous thromboembolism functional status (PVFS) from pre-PE event to discharge (P = 0.032).
• CAVT patients who performed both 30-day and 90-day six-minute walk tests demonstrated a significantly longer distance walked during the 90-day walk test (472m for CAVT vs 376m for anticoagulation alone; P = 0.019). Additionally, CAVT patients near normalized by 90-days, walking 94% of their predicted walk distance vs 75.2% in the anticoagulation only arm (P = 0.022).
• Safety rates through 90 days were comparable, with no device-related mortality, no additional PE-related mortality > 7 days, and no difference in symptomatic PE-recurrence, confirming the safety profile of CAVT.

One-Year Outcomes from STRIKE-PE Show Sustained Functional and Quality of Life Improvements After CAVT

Dr. Brian Schiro, MD, an interventional radiologist at Miami Cardiac & Vascular Institute, and an investigator for the STRIKE-PE Study, delivered an encore presentation of one-year functional outcomes and quality of life results from STRIKE-PE, a large prospective study evaluating CAVT for intermediate and high-risk pulmonary embolism.

This interim analysis of 595 patients demonstrates not only the consistent periprocedural safety of CAVT — but also compelling evidence of functional recovery. Patients experienced rapid improvement in right ventricular strain, marked by a 26.7% reduction in RV/LV ratio at 48 hours (P < 0.001), alongside short procedure times and nearly half avoiding an ICU stay.

Key findings include:³

• RV/LV ratio improved by 26.7% at 48 hours
• 47.7% avoided an ICU stay after the procedure
• Low 48-hour MAE rate: 1.8% (11/595)
• Device-related SAEs: 0.3% (2/595)

Functional Improvements at 1 Year

• 64% increase in 6-minute walk distance (6MWT) from discharge to 1 year after CAVT
• Dyspnea improved:
  • Borg scale at rest: –4.0 from baseline to 1 year after CAVT
  • Borg after 6MWT: –1.0 from discharge to 1 year after CAVT
• 87.1% of patients reached NYHA Class I or no symptoms at 1 year — better than pre-PE baseline
• EQ VAS (EuroQol Visual Analogue Scale) improved by +27.6 from baseline to 1 year, reaching U.S. population norms at 1 year

Important Safety Information

Additional information about Penumbra’s products can be located on Penumbra’s website at: https://www.penumbrainc.com/products/peripheral-thrombectomy-cavt/. The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to Instructions for Use (IFU) for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Summary Statements, visit: peninc.info/risk. Please contact your local Penumbra representative for more information.

Copyright ©2026 Penumbra, Inc. All rights reserved. CAVT and Lightning Flash are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are the property of their respective owners.

<sup>1. Lookstein R, Konstantinides SV, Weinberg I, et al. Randomized controlled trial of mechanical thrombectomy with anticoagulation versus anticoagulation alone for acute intermediate-high risk pulmonary embolism: primary outcomes from the STORM-PE trial. CIRCULATION. 2025; [Published online ahead of print]. doi:10.1161/CIRCULATIONAHA.125.077232.
2. Presented by Rosovsky, R. Randomized controlled trial of mechanical thrombectomy with anticoagulation versus anticoagulation alone for acute intermediate-high risk PE: primary outcome, functional endpoints, and core lab findings from STORM-PE. Presented at: VIVA (Vascular InterVentional Advances) 2025; November 3, 2025; Las Vegas, NV, USA.
3. Moriarty JM, Schiro BJ, Dohad SY, et al. Periprocedural results and right ventricular outcomes of computer assisted vacuum thrombectomy treatment of acute pulmonary embolism: interim analysis of 300 patients from the STRIKE‐PE study. J Am Heart Assoc. 2025;14(17):e039975. doi:10.1161/JAHA.124.039975.</sup>