Penumbra’s Lightning Flash 3.0 CAVT System Receives CE Mark Approval

November 2, 2026—Penumbra announced it has received CE Mark approval for the Lightning Flash 3.0 computer-assisted vacuum thrombectomy (CAVT) system, which includes significant upgrades to advance the company’s venous thromboembolism platform. Lightning Flash 3.0 is part of Penumbra’s Indigo system with Lightning portfolio, noted the press release.

According to the company, the latest Flash 3.0 algorithm, which was engineered for the rapid removal of pulmonary and venous thrombus, is designed for enhanced clot detection capabilities with increased sensitivity to thrombus and blood. It includes enlarged tubing coupled with an automated backflush feature tailored for large thrombus burdens and to reduce friction from aspirated thrombus.

Andrew Wigham, BSc, MBBS, with Oxford University Hospitals in Oxford, United Kingdom, and Professor Aleksander Araszkiewicz, MD, with University Clinical Hospital in Poznań, Poland, commented in the press release on the introduction of Lightning Flash 3.0 with CAVT technology in Europe.

“Since its launch I have been highly impressed by the efficacy and flexibility of the Flash system in treating complex deep vein thrombosis patients,” stated Dr. Wigham. “I am excited to see how the technological advancements of the Flash 3.0 system will translate into even faster clot removal with reduced blood loss.”

Prof. Araszkiewicz added, “Flash 3.0 represents the next breakthrough in the innovative CAVT technology. By further enhancing clot removal efficiency while significantly reducing blood loss during the procedure, it addresses two critical priorities for physicians and patients alike. The result should mean greater procedural confidence for the operator, improved procedural efficiency, and an even higher level of safety for patients suffering from acute pulmonary embolism (PE).”

Penumbra advised that results of the STORM-PE randomized controlled trial found that the use of its CAVT technology with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high–risk PE. The level 1 evidence demonstrated superior results for mechanical thrombectomy versus traditional anticoagulation for the treatment of PE. In 2025, the STORM-PE results were published by Robert A. Lookstein, MD, et al in Circulation and presented at VIVA 2025.