Interim STRIKE-PE data shows CAVT™ with Lightning Flash™ improve clinical and functional outcomes

Interim data from the STRIKE-PE study assessed a subset of 164 pulmonary embolism (PE) patients who were treated with Penumbra’s Lightning Flash technology. The findings show that Penumbra’s computer assisted vacuum thrombectomy (CAVT) technology, when used as a frontline therapy for PE, is not only a safe, fast and effective procedure, but also improved both clinical and functional outcomes.¹ The data were presented during April’s Charing Cross (CX) 2025 vascular and endovascular symposium in London.

This interim subgroup analysis showed:

• Significant reduction of the right ventricular/left ventricular ratio by 27.8%
• Significant decrease in systolic pulmonary artery pressure of 23.4%
• Low overall major adverse event rate of 0.6%
• Fast device time of 25.5 minutes (median)

“As one of the largest and most comprehensive PE trials, STRIKE-PE will allow us to evaluate the impact of CAVT on a broad range of patients,” said Professor Andrew Sharp, MBChB, MD, Professor of Cardiology, Mater Misericordiae University Hospital, and University College Dublin, Ireland. “The real-world data from this latest subset allow us to evaluate the impact of one of the latest CAVT technologies as we continue to assess long-term functional and quality of life data.”

Penumbra’s Lightning Flash portfolio is one of the most advanced mechanical thrombectomy systems on the market to address venous and pulmonary thrombus. It features Penumbra’s CAVT technology with the latest dual clot detection algorithms, using both pressure and flow-based processes to detect blood clot and blood flow. The Lightning Flash catheters are made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. They are designed to help remove blood clots with speed, safety and simplicity, allowing physicians to better navigate the body’s complex anatomy and deliver high power aspiration for clot removal.

PE is the leading cause of hospital death and the third most frequent cause of cardiovascular mortality. Traditionally, treatment options have included anticoagulation, thrombolysis or surgery, however, catheter-directed interventions, including catheter-directed thrombolysis and aspiration thrombectomy, have been developed for patients with intermediate- or high-risk PE.²

Important Safety Information:
Additional information about Penumbra’s products can be located on Penumbra’s website at https://www.penumbrainc.com/eu/products/peripheral-thrombectomy-indigo-system/. Product availability varies by country. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Risk Statements, visit peninc.info/risk. Please contact your local Penumbra representative for more information.

Copyright ©2025 Penumbra, Inc. All rights reserved. CAVT and Lightning Flash are a registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are the property of their respective owners.

Sources:
1. Schiro, B. Computer assisted vacuum thrombectomy with Lightning Flash for acute pulmonary embolism patients: STRIKE-PE analysis of 164 patients. Presented at: SIR (Society of Interventional Radiology) 2025; Nashville, TN, USA.
2. Salinas P et al. Catheter-directed interventions in acute pulmonary embolism. Position statement of SEC-Interventional Cardiology Association / SEC-Ischemic Heart Disease and Acute Cardiovascular Care Association / SEC-Working Group on Pulmonary Hypertension. Rev Esp Cardiol. 2015;78(3):239-251.