Penumbra Receives CE Mark for Lightning Bolt 12 and Lightning Bolt 6X with TraX in Europe

Penumbra Inc., the world’s leading thrombectomy company, has secured CE Mark for its Lightning Bolt^® 12 and Lightning Bolt 6X with TraX™ — the next generation of its groundbreaking computer assisted vacuum thrombectomy (CAVT™) devices. These latest advancements provide even faster clot removal, designed to rapidly restore flow, potentially without the need for thrombolysis or open surgery.¹

The new Lightning Bolt 12 enables physicians to aspirate three times faster than the previous generation, while the new Lightning Bolt 6X with TraX enables 6 F vascular access and the ability to reach smaller vessels.¹

These latest advancements complement an already robust vascular thrombectomy portfolio featuring Lightning Bolt 7 and Lightning Flash^® 2.0. Penumbra’s Lightning portfolio of CAVT technology combines intelligent aspiration and innovative catheter engineering designed to quickly remove blood clots in a single session.

“These new technologies allow physicians the versatility to bring the power of CAVT to more of the body for the management of arterial and venous blood clots,” says Joan Kristensen, VP & Head of Penumbra EMEA. “With advanced dual clot algorithms and state of the art catheters, they are designed to significantly improve procedure time and accelerate aspiration.”

Lightning Bolt 12

Lightning Bolt 12 is the first thrombectomy system designed for venous thromboembolism with modulated aspiration. Paired with the updated Bolt 2.0 software, Lightning Bolt 12 joins Penumbra’s complete VTE platform and brings modulation to a 12 F profile. Its applications are diverse, including upper extremity, portal veins, and large arterial thrombus. The Bolt 2.0 algorithm is engineered for improved clot removal efficiency, using escalated modulation for high thrombus burden, making the system three times faster than Lightning® 12 with Separator™ 12.¹

“With the launch of Lightning Bolt 12, Penumbra completes its venous portfolio by introducing a system perfectly suited for specific indications such as Thoracic Veins and Upper Arm Deep Vein Thrombosis,” said Dr. Charlott Köhler, consultant vascular surgeon at St. Franziskus-Hospital in Münster, Germany.
“I was amazed by the performance of the device in aspirating organized thrombus with almost no blood loss,” said Dr. Arne Schwindt, consultant vascular surgeon at St. Franziskus-Hospital in Münster, Germany. “It’s incredibly fast and simple to use.”

Lightning Bolt 6X with TraX

Lightning Bolt 6X with TraX allows physicians to reach and address smaller vessels with confidence. The new CAT™6X catheter with advanced coil-wind technology is designed for precise control and versatility in smaller vessels. The enhanced hydrophilic coating is designed to create a smoother passage through the most difficult vessels by reducing friction to maximize efficiency. It comes packaged with the TraX Dilator, Penumbra’s first arterial-designed dilator that provides a 99% ledge reduction to support a continuous, seamless experience.

“The device is remarkably fast, reaching the foot within seconds, and its smooth navigation through complex anatomy is truly impressive,” said Dr. Artur Mieczkowski, angiologist at University Hospital No. 2 in Bydgoszcz, Poland. “TraX is unique and navigates complex anatomy with remarkable precision and ease.”

Important Safety Information

Additional information about Penumbra’s CAVT 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 Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Risk information can be found at peninc.info/risk. Please contact your local Penumbra representative for more information.

Copyright ©2025 Penumbra, Inc. All rights reserved. Lightning Bolt, TraX, CAVT, Lightning Flash, Lightning, Separator, and CAT are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries.

^{1. Bench top testing comparing aspiration times of Lightning Bolt 12 v Lightning 12 and Lightning Bolt 6x with TraX vs. CAT 6 and Separator 6. Tests performed and data on file at Penumbra, Inc. Bench test results may not be indicative of clinical performance.}