Penumbra’s Lightning Bolt 12 and Lightning Bolt 6X With Trax Approved in Europe

December 3, 2025—Penumbra Inc. announced it has secured CE Mark approval for its Lightning Bolt 12 and Lightning Bolt 6X with Trax. These next-generation devices of its computer-assisted vacuum thrombectomy—CAVT—technology provide faster clot removal to rapidly restore flow, potentially without the need for thrombolysis or open surgery, noted the company.

According to Penumbra, the Lightning Bolt 12 thrombectomy system is designed for venous thromboembolism (VTE) 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 include upper extremity, portal veins, and large arterial thrombus.

Penumbra stated that the Lightning Bolt 6X with Trax enables 6-F vascular access and the ability to reach smaller vessels. The CAT 6X catheter features advanced coil-wind technology for precise control and versatility in smaller vessels.

Charlott Köhler, MD, and Arne Schwindt, MD, who are consultant vascular surgeons at St. Franziskus-Hospital in Münster, Germany, commented on the Lightning Bolt 12 in the company’s press release.

“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,” stated Dr. Köhler.

Dr. Schwindt added, “I was amazed by the performance of the device in aspirating organized thrombus with almost no blood loss. It’s incredibly fast and simple to use.”

Commenting on the Lightning Bolt 6X with Trax in the press release, Artur Mieczkowski, MD, stated, “The device is remarkably fast, reaching the foot within seconds, and its smooth navigation through complex anatomy is truly impressive. Trax is unique and navigates complex anatomy with remarkable precision and ease.” Dr. Mieczkowski is an angiologist at University Hospital No. 2 in Bydgoszcz, Poland.