Penumbra has received CE Mark certification in Europe for the Lightning Flash 2.0 and Lightning Bolt 7 computer-assisted vacuum thrombectomy (CAVT) technologies.
According to the New York Stock Exchange (NYSE)-listed thrombectomy company, these technologies aim to improve clot removal procedures in the vascular system.
Penumbra claimed that its Lightning products will be the only CAVT systems available in Europe.
Penumbra chief medical officer James Benenati said: “Based on outcomes from our clinical trials and from physicians using our devices globally, our CAVT technologies have greatly improved our ability to rapidly and safely remove clot in the vascular system.
“With quicker procedures and more efficient clot removal, we have improved outcomes while demonstrating a high level of safety.
“As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 and Lightning Bolt 7 will provide physicians in Europe with the confidence that CAVT is a valuable first line option to manage conditions such as PE, venous thrombosis, and acute limb ischemia.”
Lightning Flash 2.0 is a mechanical thrombectomy system designed to address venous and pulmonary thrombus. It was cleared by the US Food and Drug Administration (FDA) in April 2024.
The system incorporates Penumbra’s Lightning Intelligent Aspiration technology, which includes clot detection algorithms using pressure and flow-based processes to identify blood clot and blood flow.
The Lightning Flash 2.0 catheter uses the MaxID hypotube technology, which provides an inner diameter similar to large-bore catheters while maintaining a lower profile. It features a tip design that aims to remove blood clots quickly and safely, allowing for navigation through complex anatomical structures and delivering aspiration for clot removal with reduced blood loss.
The system also provides audio-visual feedback, allowing physicians to monitor activity at the catheter tip during procedures.
On the other hand, Lightning Bolt 7 is an arterial thrombectomy system designed for removing blood clots. It introduces modulated aspiration, a method that combines Penumbra’s Lightning Intelligent Aspiration technology with a microprocessor algorithm.
This system aims to improve the removal of large, fibrous blood clots in the arteries while reducing blood loss. It addresses conditions such as acute limb ischemia, hibernating thrombus, and visceral occlusions.
Lightning Bolt 7 is designed to detect differences between blood clot and blood flow and to modulate aspiration to break the friction between the catheter and clot, allowing for the ingestion of blood clots. It received FDA clearance in June 2023.
Lightning Flash 2.0 and Lightning Bolt 7 follow Penumbra’s recent CE Mark certification for five stroke reperfusion and access catheters, which expands its neuro and vascular portfolios in Europe.
