Penumbra has secured CE Mark for the Lightning Flash™ 3.0 Computer Assisted Vacuum Thrombectomy (CAVT™) system, which includes significant upgrades that further advance our leading venous thromboembolism (VTE) platform.
“The launch of Lightning Flash 3.0 reflects Penumbra’s commitment to continuous innovation and improvement. By advancing our algorithms and catheter technology, we are helping physicians remove clot more efficiently and enhancing the treatment experience,” said Joan Kristensen, head of the Europe, Middle East and Africa region for Penumbra. “For physicians across Europe who care for patients with complex clot-related conditions, innovations such as Lightning Flash 3.0 are an important step in expanding access to advanced treatment options.”
Engineered for the rapid removal of pulmonary and venous thrombus, the latest Flash 3.0 algorithm is designed for enhanced clot detection capabilities with increased sensitivity to thrombus and blood. Lightning Flash 3.0 includes enlarged tubing coupled with an automated backflush feature tailored for large thrombus burdens and to reduce friction from aspirated thrombus.
These improvements result in a thrombectomy system that builds upon the speed, safety, and simplicity of Penumbra’s CAVT platform, including:
- 1.3x faster clot removal time1
- 60% fluid savings1
- Upgraded user interface with streamlined audio-visual feedback, including a visual display with vacuum and flow indicators
The introduction of Lightning Flash 3.0 in Europe is welcomed by current users of the CAVT technology.
“Since its launch I have been highly impressed by the efficacy and flexibility of the Flash system in treating complex DVT patients. 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,” said Dr. Andrew Wigham, Oxford University Hospitals, UK.
“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,” said Prof. Aleksander Araszkiewicz, University Clinical Hospital Poznań, Poland, who is principal investigator of the STRIKE-PE study.
The STORM-PE randomised controlled trial, recently published in Circulation, found that the use of Penumbra’s CAVT technology with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high risk pulmonary embolism (PE). This marks the first Level 1 evidence demonstrating superior results for mechanical thrombectomy over traditional anticoagulation for the treatment of pulmonary embolism (PE).
“Aspiration with Flash 3.0 allows physicians to optimise thrombus removal with continued improvements in procedure time while simultaneously minimising blood loss. These advances may translate to significant improvements in patient safety and efficiency for physicians performing these procedures,” said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “Along with the recent landmark STORM-PE findings, Lightning Flash 3.0 will provide physicians with the confidence that CAVT is a valuable frontline option and will allow for a more rapid adoption of thrombectomy.”
Lightning Flash 3.0 is part of Penumbra’s Indigo™ System with Lightning™ portfolio. The company’s Lightning products are the only CAVT systems currently available in Europe and the U.S. Lightning Flash is part of Penumbra’s complete VTE Platform, and are compatible with the Select™ + catheter, The CAT™ 16 Aspiration Catheter, and the ELEMENT™ Vascular Access System.
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/. 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. Risk information can be found at peninc.info/risk.
Copyright ©2026 Penumbra, Inc. All rights reserved. Lightning Flash, CAVT, Indigo, Lightning, Select, CAT, and ELEMENT are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries.
1. Compared to Lightning Flash 2.0. Tests performed and data on file at Penumbra, Inc. Test performed using bovine blood and water. Bovine blood took 1.3× more time to be fully ingested in bench top testing of Lightning Flash 2.0 when compared to Lightning Flash 3.0, while 60% less water was removed with Lightning Flash 3.0 when compared to Lightning Flash 2.0. Bench test results may not be indicative of clinical performance.
