Penumbra’s Lightning Flash 2.0 and Lightning Bolt 7 CAVT Systems Receive CE Mark Approval

September 16, 2024—Penumbra, Inc. announced it has received CE Mark approval for its Lightning Flash 2.0 and Lightning Bolt 7 computer-assisted vacuum thrombectomy (CAVT) devices.

The Lightning Flash 2.0 thrombectomy system addresses venous and pulmonary thrombus. Lightning Bolt 7 is an arterial thrombectomy system that introduces a new method for removing blood clots—modulated aspiration.

According to the company, the Lightning Flash 2.0 CAVT system is 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 with minimal blood loss. It features the company’s Lightning Intelligent Aspiration 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 2.0’s catheter is made with MaxID hypotube technology, which allows an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. Additionally, the system’s streamlined audio-visual feedback enables physicians to have a better understanding of what is occurring at the tip of the catheter during a procedure.

Penumbra stated that the Lightning Bolt 7 CAVT system’s modulated aspiration pairs the Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm. When used together, the system is designed to enhance the ability to rapidly remove large, fibrous blood clots in the arteries with minimal blood loss, addressing conditions such as acute limb ischemia, hibernating thrombus, and visceral occlusions.

Additionally, the Lightning Bolt 7 is designed to detect the difference between blood clot and blood flow. It breaks the friction between the catheter and clot by having the computer algorithms rapidly modulate aspiration to quickly fatigue the thrombus and remove the clot from the arteries. This facilitates maximum vacuum force at the catheter tip for optimal, rapid ingestion of blood clots, noted Penumbra.